8974052

Are Electric Toothbrushes More Effective In Reducing Plaque Than Manual Toothbrushes?

Supervisor: Professor Nicholas Grey

Word Count: 3,758 Student ID: 8974052

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Abstract

Background

Plaque-associated diseases, such as gingivitis and periodontal disease are widely prevalent among the UK population; a study conducted by the Adult Dental Health Survey (2009) found that “66% of dentate adults had visible plaque on at least one tooth.” It has been suggested that such diseases have “considerable impacts on individuals and society and are costly to treat” (Batchelor, 2014). Treatment of plaque-associated diseases may consist of scaling (sub and/or supra elements) and also “at home care” e.g. the use of toothbrushes, of which there are a wide range. Patients therefore, may struggle to decipher which product is the most effective. This paper aims to identify whether ‘powered’ toothbrushes are more effective than manual toothbrushes in reducing plaque.

Method

Cochrane, PubMed and Medline databases were searched for studies that compared the efficacy of electric and manual toothbrushes in reducing plaque. Studies were required to be tested on humans and to be in ‘full English text.’ A total of three studies were found to be suitable.

Results

All three studies conclusively found that electric toothbrushes were statistically significant in reducing plaque, compared to manual toothbrushes.

Conclusion

With the set criterion, there is not enough ‘high quality’ evidence to suggest that electric toothbrushes are more effective in reducing plaque than manual toothbrushes. Therefore, further research is required in order to strengthen available evidence.

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Contents

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1) Background

Clinical scenario

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1. BackgroundClinical Scenario

4 4

IntroductionDental PlaquePrevalenceAetiologyPotential Treatment Options

4 4 4

5 5

2. Research Question 8

3. Identification of Studies 8

4. Search Results and Inclusion Criteria 9

5. Critical Appraisal 13

6. Summary 16

7. Implications for Future Practice and Research

20

8. Research protocol 21

9. Bibliography 24

A patient presents with high plaque and bleeding scores. The patient states they are currently using a manual toothbrush and wonders whether a ‘powered’ toothbrush would be more effective in reducing their plaque and bleeding scores. “Delivering Better Oral Health” (2014) helps provide advice on reducing the incidence of plaque- associated diseases by suggesting the “brushing of the gum line and each tooth twice daily either with a manual or powered toothbrush.”

The patient states that they have seen ‘powered’ toothbrushes advertised and wondered whether they were worth the investment.

You are unsure whether powered are more effective in reducing plaque than manual toothbrushes and therefore, decide to consult available literature.

Introduction

Dental Plaque

Dental plaque is defined “as the soft deposits that form the biofilm adhering to the tooth surface” (Sudhakar et al., 2008) and is “composed of organic and inorganic materials derived from saliva, crevicular fluid and bacterial products.” (Rao, 2012)Dental plaque is described as the “aetiological agent” (Seneviratne CJ, 2016) for both gingivitis and periodontal disease and as a result may “affect the course and pathogenesis of a number of systemic diseases, such as cardiovascular disease, bacterial pneumonia, diabetes mellitus and low birth weight.” (Xiaojing Li, 2000)Gingivitis may present as bleeding and/or reddened gingivae, eventually resulting in bone or clinical attachment loss to the surrounding periodontium; (Periodontitis.) Periodontitis may also present with recession, excessive probing depths and mobile teeth.

Prevalence

Gingivitis is common in “early childhood, more prevalent and severe in adolescence and tends to level off in older age groups” (Burt, 2005). However, periodontitis is more likely seen in older patients than younger patients “due to many years of exposure and the various risk factors associated with periodontitis.” (Noble, 2012) Periodontitis also has a higher prevalence among men than in women, yet this may be attributed to lower dental attendance rates that are associated with men.

Aetiology

8974052 environmental determinants

PhysicochemicalWater

pH of saliva

Adhesion, Aggregation

and Coaggregation

Nutritional Diet

Host ProtectionAmount of

saliva

5

The ‘environmental determinants’ that affect microorganisms in the development of plaque can be categorised into four factors (Fig. 1) Moreover, for both gingivitis and periodontitis there are established ‘risk’ (smoking and stress) and ‘background factors’ (age, gender, ethnicity, and genetics) that allow the development of such diseases to become more likely.

Potential Treatment Options

Treatment of plaque induced diseases such as gingivitis and periodontitis ‘can be improved by the sole use of oral hygiene.’ Renz et al., (2007) However, depending on the severity of the disease it may be necessary for the dental care professional to remove deposits of calculus and potential stagnation sites. This may hinder an individual’s ability to effectively remove deposits in addition to controlling any potential risk factors to the disease such as smoking, diabetes, and/or diet.

Oral hygiene instruction given by the dental care professional and ‘at home care’ is synergistic; in order to ensure effective plaque removal the patient must be shown how to effectively remove deposits; by use of either a ‘powered’ or manual toothbrush.

For use of manual toothbrushes, ‘the modified bass technique’ (as shown below in Fig. 2) is the

recommended way of brushing and was shown to have a “2.9 fold effectiveness over normal practices in reducing plaque.” Poyato-Ferrera M, (2016)

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Fig. 1: Environmental Determinants (Perioexpertise.com, 2016)

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‘Powered’ toothbrushes may be divided into several categories, the most common types being the oscillating-rotating, which has a smaller rounded head, and the sonic. Sonic powered toothbrushes, as shown in Fig. 3, have a vibrating side-to-side motion and bare some resemblance to that of the manual toothbrush in both appearance and instrumentation. When using Sonic powered toothbrushes patients, as with a manual toothbrush, must adopt small circular rolling movements and angle the toothbrush 45-degrees towards the gingival margin. In contrast, it is not necessary when using the oscillating-rotating powered toothbrush, to adopt the use of small circular movements, as the toothbrush itself does this automatically.

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Fig. 2: The Modified Bass Technique (MEDCHROME, 2013)

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A key factor to consider is the possibility that the population who own either ‘powered’ toothbrushes (sonic or oscillating-rotating) or manual toothbrushes have differing understandings of how to use them effectively. A study in Sweden in 2013 conducted by the Sahlgrenska Academy, University of Gothenburg showed that most people did in fact brush their teeth on a regular occurrence, yet, ‘only a few’ knew the best brushing technique.’ (Jensen O, 2016)

The recommended brushing time as mentioned by “Delivering Better Oral Health” (2014) is two minutes; however, most people over estimate their brushing time. Manufacturers and supporters of electric toothbrushes claim the effectiveness of electric toothbrushes over manual toothbrushes comes from both the built in timers (mostly set at 2-3 minutes;) which many electric toothbrushes now have, and also reduction of skill required in order to effectively use them (less pressure and less movement.)

2) Research Question

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Fig. 3: Oscillating-rotating and Ultrasonic (Best Oral Hygiene, 2014)

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Are electric toothbrushes more effective in reducing plaque than manual toothbrushes?

To formulate an effective research question I used the PICO format:

Population: Patients suffering from plaque induced diseases, e.g. Gingivitis

Intervention: Electric toothbrushes

Comparison: Manual toothbrushes

Outcome: Reduction in plaque-induced diseases and overall plaque levels

3) Identification of studies

The following primary concepts were identified:

-Plaque

-Manual toothbrushes

-Electric toothbrushes

-Powered toothbrushes

Searches were then made using the following databases:

Cochrane databases 18/10/15

Number Searches Results

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1 Powered toothbrush 52 Electric toothbrush 23 Plaque 444 Manual toothbrush 55 1 and 3 and 4 46 2 and 3 and 4 17 5 or 6 78 7 Publication date

>20007

PubMed (Medline) 18/10/15Number Searches Results

1 Powered or Electric Toothbrush

457

2 Plaque 889263 Manual toothbrush 4534 1, 2 and 3 1935 Limit 4 to

Full text Human English language Publish date

after 2000 Ages 18-65 years

32

Embase 1974 to 2015 week 49 (Ovid)

Number Searches Results1 Powered toothbrush or

electric toothbrush142

2 Plaque 1147783 Manual toothbrush 104 1 and 2 and 3 44 Limit 4 to:

Full text Human English language Publication date

after 2000 Ages 18-65 years

2

4) Search results and inclusion criteria

Inclusion criteria

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Patients: Had at least 20 fully-erupted permanent teeth Did not have implants Patients were not wearing fixed or removable appliances Patients were fit and healthy, with no impairments other than an established

gingival disease Were 18-65 years of age Did not have established severe periodontal disease Studies: Must look at plaque levels Randomized controlled trials must be over 4 weeks Must compare manual toothbrushes to electric toothbrushes No other dentifrices used in the study e.g. floss ionic toothbrushes not included within studies

Accepted Studies

Of the 41 studies identified from the databases 3 were found to be suitable (below)

1. Zimmer S. et al., (2002). Clinical efficacy of a new sonic/ultrasonic toothbrush.

2. Dentino A.R. et al., (2002). Six-month comparison of powered versus manual toothbrushing for safety and efficacy in the absence of professional instruction in mechanical plaque control.

3. Mielczarek A., Banach, J. and Górska, R., (2013). Comparison of Effectiveness of Manual and Electric Toothbrushes in Elimination of Dental Plaque and Gingivitis Reduction. (*)

Articles within the systematic review (*) were subsequently researched, allowing the following study to be accepted:

Jain, Y. (2013). A comparison of the efficacy of powered and manual toothbrushes in controlling plaque and gingivitis: a clinical study- gave instructions

Rejected Studies

A Cochrane review, such as “Powered versus manual tooth brushing for oral health” (Yaacob et al.,., 2014) is regarded as the “gold standard” in scientific research. However, due to a plethora of reasons; e.g. the inclusion of children and orthodontic patients no studies form this systematic review could be accepted. A further systematic review, Mielczarek, A., Banach, J. and Górska, R. (2013) was also cross-referenced for studies that met the inclusion criteria; allowing Jain, Y. (2013) to be accepted. Many results from the databases were also found to be irrelevant to the

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subject or included patients with medical impairments. A full explanation of rejected studies can be seen in the diagrams below.

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Cochrane 7 results

5 Irrelevant 2 Excluded

1 study systematic review(Yaacob et al., 2014)

1 study looked at different modes of

toothbrushes and did not compare to manual toothbrushes

(Deacon et al., 2010)

Embase 2 results

1 Irrelevant 1 systematic review

(Mielczarek, A., Banach, J. and Górska, R, 2013)

Cross Referenced (Mielczarek, A., Banach, J. and Górska, R, 2013)

to find (Jain Y, 2013)

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Pubmed 32 results

2 Included(Zimmer S et al., 2002)

(Dentino AR et al., 2002)

4 irrelevent 26 excluded

7 studies included orthodontic patients

(Marini I et al., 2014) (Erbe C et al., 2013) (Costa MR et al., 2010)

(Hickman J et al., 2002) (PG, 2005)(Thienpont V et al., 2001) (Costa MR

et al., 2007)

7 studies included patients with severe

peridontal disease (McCracken GI et al., 2004) (Bogren A et al.,,2008) (Bogren A et al., 2007) (Sicilia A et al., 2009) (Haffajee AD et

al., 2001) (Gugerli P et al., 2007) (Lazarescu D et al., 2003)

1 study compared different types of

electric toothbrushes not comparing them to manual

toothbrushes (Claydon N et al., 2004)

4 studies included patients with medical

impairments (Sharma A et al., 2012) (Doğan MC et

al., 2004) (Yuen HK et al., 2011)

1 study included patients with implants(Vandekerckhove B et al., 2004)

1 study used other dentrifices (floss)

(Rosema NA et al., 2008)

3 studies no full text available

(Williams K et al., 2004) (Pizzo G et al., 2010)(Terézhalmy GT et al., 2005)

1 study involved Hygienists brushing for the patients

(Danser MM et al., 2003)

1 study used an ionic toothbrush (van der Weijden et al., 2002)

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Study Patient group Intervention Details Outcomes Assessed Key Results Study Type, Including Strengths, Weaknesses and Potential Bias

Zimmer S, et al.,.(2002)

PubMed

Berlin, Germany

64 subjects (32 males and 32 females)

63 completed the trial, one subject excluded from analysis because of missing last examination

Inclusion Criteria:

A PBI (Papillary Bleeding Index, Mühlemann & Son 1971) per tooth ≥ 0.5

A PI (Quigley-Hein Plaque Index 1962) per tooth ≥ 2.0

Exclusion Criteria:

Severe Periodontal Disease

Long-term use of anti-inflammatory drugs

Removable Dentures

Less than 20 Natural teeth

Regular use of an electric toothbrush during the past year

After a screening examination and stratification by age, sex and papillary bleeding index (PBI), the participants were randomly assigned to two groups with 32 subjects in each.

The two toothbrushes used were as follows:

1. A powered toothbrush: Ultra sonex Ultima ®

2. A manual toothbrush: (Aronal öko dent kompakt, medium, 31 tufts, GABA, Lörrach, Germany)

Subjects were provided with a professional tooth cleaning and given the same toothpaste (Elmex, GABA, Lörrach, Germany.)

Subjects were given OHI by a person not involved in the study and instructed to brush for 3 mins for two times/day and were provided with an hour glass (GABA)

-Electric toothbrush technique: instructions to follow the manufacturer’s recommendations

- Manual toothbrush Technique: Modified Bass

*During the study period, mouth rinses, gels and the use of any interdental cleaning aids were prohibited

All examinations were treatment blind and performed by one examiner

Clinical Parameters:

1.The Approximal Plaque index (API) (Lange et al.,.1977) Qualitative (yes/no decision)

2.Turesky modification (1970) of the Quigley-Hein Plaque index (PI) Rated on a scale of 0-4

3.The Papillary Bleeding Index (PBI) (Mühlemann & Son 1971)Rated on a scale of 0-5

* All recorded at baseline, and again at 4 and 8 weeks

At baseline, there was no statistically significant difference between any indexes.

Approximal Plaque Index:There were no statistically significant differences after 4 and 8 weeks (p>0.001)

Plaque Index:A statistically significant difference was found after 4 and 8 weeks (p<0.001) At the end of the study the median PI for the manual group was 1.96 compared to 0.92 for the powered group.

Papillary Bleeding index:A statistically significant difference was found after 4 and 8 weeks (p<0.001) At the end of the study the median PBI for the manual group was 0.63 compared to 0.29 for the powered group.

Overall:The powered brush resulted in marked reductions but not in complete removal of plaque. Regarding the PI and PBI the Ultra sonex Ultima ® was more efficacious in removing plaque and preventing gingivitis than the manual toothbrush.

Randomised parallel-design treatment-blind study over an 8-week period

Stratified randomisation Standardized conditions: groups given same

toothpaste Instructions given by someone not involved in the

study All subjects told to brush for the same amount of

time p value= 0.001 Toothpaste was weighed following completion to

determine whether subjects had over or under used

8 weeks Intra examiner reliability was tested with repeated

measurements Statistical analysis was performed with SPSS 9.0

program The Mann-Whitney U-test was used for non-

parametric unrelated samples Friedmann test was used for non-parametric

related samples Justified brushing time for 3 mins (recommended

in Germany) Sample size of only 63 subjects, 1 exclusion from

analysis Age range of subjects not mentioned Single-blind Unclear whether subjects were given OHI by the

same person Potential for Hawthorne effect No power calculation done Study funded by Sonex Deutschland therefore,

giving the potential for bias No explanation of the randomisation process Median toothpaste use for the manual brush was

61.9g and 72.0g for the electric brush Qualitative plaque assessment (API) not

appropriate for this study

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5) Critical Appraisal

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Study Patient group Intervention Details Outcomes Assessed Key Results Study Type Including Strengths, Weaknesses and Potential Bias

Jain, Y. (2013)

Embase

Gurgaon (Haryana), India.

60 Dental Students of both sexes, with ages ranging from 18-28 years.

Inclusion criteria:

Good general and oral health No periodontal therapy during

the past three months Moderate gingivitis (at least

25% of test sites showing bleeding on probing)

Ability to attend the hospital at recall intervals

All teeth present, except third molars

Exclusion criteria:

Poor manual dexterity Use of drugs that could affect

the state of the gingival tissues Current orthodontic therapy Muco-gingival problems 5 or more carious teeth requiring

immediate treatment Use of any other supplemental

plaque control measures, such as interdental cleansing aids or mouthwashes

A habit of taking alcohol, smoking or chewing tobacco

Eligible subjects were stratified and randomized to one of the two brushing groups.

Randomisation was carried out by using the coin toss method by a second examiner who was not involved in the recording of clinical parameters.

Group A (n=30)

Toothbrush: (Manual) Oral B® Classic ultraclean mediumDentifrice: Pepsodent®Technique: Modified BassDuration of brushing: 2 mins

Group B (n=30)

Toothbrush: (Powered) Oral B® vitality dual cleanDentifrice: Pepsodent®Technique: Bristles perpendicular to gingival marginDuration of brushing: 2 mins

Prior to the study Scaling and polishing was done for all subjects, and their baseline scores were made zero.

Told to return at 1,2 and 6 weeks

Clinical findings were recorded at one, two and six weeks at six sites on each tooth (distobuccal, mid-buccal, mesio-buccal, disto-lingual, mid-lingual and mesiolingual.)

Three Clinical Parameters:

-Plaque Index (O’Leary, 1972) with aid of a disclosing agent: Alpha Plac DPI

-Oral Hygiene Index-Simplified (Green and Vermillon, 1964)

-Gingival Index (Loe and Silness, 1963)

*Carried out with a William’s Periodontal probe and a mouth mirror under a dental light.

Plaque Index (O’Leary, 1972):

2 weeks:Group B had statistically significantly lower (p= 0.0014) mean plaque scores (44.033) compared to Group A (60.255)

6 weeks:Group B had statistically significantly (p= <0.001) lower mean plaque scores (20.491) compared to Group A (43.786)

Oral Hygiene Index-Simplified (Green and Vermillon, 1964)

The mean Oral Hygiene score for Group A fell from 0.596 on the 7th day to 0.196 on the 42nd day. Group B also showed a decline from 0.703 on the 7th day to 0.18 on the 42nd day. However, in comparing the two groups there was no statistically significant difference.

Gingival Index (Loe and Silness, 1963)

The mean Gingival score for Group A fell from 1.156 on the 7th day to 1.038 on the 42nd day. Group B also showed a decline from 1.145 on the 7th day to 1.018 on the 42nd day, however, in comparing the two groups there was no statistically significant difference.

Overall:There was a definite and gradual improvement in reduction of plaque and health of gingiva observed in both groups by the sixth week. However, the subject group using the powered toothbrush demonstrated clinical and statistical improvement

6 week (45 days), Parallel arm, Double Blind RCT Showed method of

randomisation No drop outs All subjects maintained recall

appointments Double-blind Both groups given the same

toothpaste Used a paired t-test p- Value set at 0.05 Proforma prepared for the

study Author reports not conflicts of

interest Subgroups/parameters

compared and evaluated using student’s t-test

Unpaired t-test used 6 weeks 60 subjects Included dental students, who

will know the correct way to brush their teeth

Did not show how subjects were stratified

Used the coin toss method for randomisation

No power calculation No specified amount of

toothpaste stated Toothpaste was not weighed

during or at the end of the trial to see over/under use

Hawthorne effect No female: male ratio shown No funding source stated Not clear who carried out OHI

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in overall plaque scores.Study Patient group Intervention Details Outcomes Assessed Key Results Study Type Including Strengths, Weaknesses

and Potential Bias

Dentino AR et al.,

(2002)

PubMed

Wisconsin (USA)

Medically healthy subjects (18-65 years)

172 subjects met screening criteria

157 subjects finished the trial

15 subjects did not finish trial

Screening criteria: (performed by a Periodontist)

Inclusion Criteria:

-Modified Gingival Index (MGI) of at least 1.2

-20% or more sites showing bleeding on probing

-No previous experience using a powered toothbrushNatural Teeth

Patients were stratified by gender, MGI, plaque index and smoking via a computer program and randomly assigned to two groups:

1. Oscillating Rotating Powered toothbrush (PB) (n=76)

2. ADA accepted standard soft- bristle Manual toothbrush (M) (n=81)

Instructions given:1. (PB) Group told to read

manufacturer’s instructions2. (M) Group provided with an

ADA approved pamphlet3. Both groups were told to abstain

from flossing/mouthwash or any other dentifrices than those provided

4. Both groups told to brush two times/day for 2 mins

Other: All subjects were given the

same toothpaste (Crest, Procter & Gamble)

Patients were given a prophylaxis at baseline

No timer was given to MB group

PB group had built in timer to toothbrush

Both groups told to return at 3 months for measurements/assessments and replacements of toothbrushes and heads

A total of 157 subjects were assessed:PB (n=76) and M (n=81)

Calculus and stain assessments: (single examiner) consisted of two parts (canines were not included)

1. Volpe-Man hold calculus index: assessed on lingual surfaces of mandibular incisors, using a UNC probe. Analysed as a mean value per tooth

2. Claydon stain index: facial surfaces of maxillary and mandibular incisors

Measures of inflammation

1. Gingival Crevicular Fluid (GCF): single examiner 4 sites per tooth, on randomly selected patients (n=126), GCF samples collected from posterior interproximal sites using a standard method (collected for 30 secs) results collected using an electronic impedance device)

2. Lobene Modified Gingival Index: (2 calibrated examiners) Facial/lingual, marginal tissue and interproximal papillae scored on a scale of 0-3, full mouth means calculated

3. Percent of sites with Bleeding on Probing (BOP): (Dual examiner) Using a UNC probe and a dichotomous index on 6 sites per tooth, 30 secs after probing (bleeding present/absent)

Measure of plaque

1. Turesky modification of the plaque index- used disclosing solution, and calculated at baseline 3 and 6 months

Time spent brushingWhen subjects returned at 3 and 6 months, they were instructed to brush in a room separate to the examiner and were timed without their knowledge.

Calculus and stain assessments:

1. Volpe-Man hold calculus index: PB users were found to have lower calculus levels at 3 months (p=0.0304) and 6 months (p=0.0078)

2. Claydon stain index: No statistical significant difference for stain between PB and M groups, even though values at 3 & 6 months numerically favoured PB users.

Measures of inflammation

PB group’s change from baseline remained greater in all tests at the 6-month assessment, but there was no significant statistical difference

Measure of plaque

1. Turesky modification of the plaque index

At 3 months: Greater reduction in full mouth plaque levels of PB (0.29) compared to M (0.13) (p=0.027)

At 6 months: Statistically significantly lower plaque levels for PB (1.09) compared to M (1.39) (p=0.0025)

Time spent brushingPB (125 secs), M (84 secs) (p=0.0157)

(PB) 50/76 spent 2 mins brushing (M) 14/81 spent 2 mins brushing

6 month, single-masked parallel design, randomised clinical trial.

6 months 157 subjects completed the trial Paired t-tests Shown stratification process Analysis of variance (ANOVA) Analysis of covariance (ANCOVA) Power calculation done (80%) Patients were stratified using a computer

program All given the same toothpaste Patients screened by periodontist Single examiner for calculus and stain

assessment showed strong reproducibility Noted the state of the toothbrushes when they

came back for recall, to see whether they had been used or not

Bristle splaying showed all subjects had used the brush

Baseline measurements showed the population as a whole entered with gingivitis

No explanation of the randomisation process 15 did not complete the trial Unclear which groups the 15 dropouts were

from Members of the same household were given

the same toothbrush Toothpaste was not weighed at end of study Time constraints not all patients’ GCF

measured Funded by Braun/Oral B® Limited usefulness of stain assessment:

subjects started with stain variability Inclusion of smokers; reduction in BOP Only included Caucasian race Female heavy More smokers in manual group (7more) Single examiner

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6) Summary

Notable similarities and differences in approach

The three independent studies carried out by Zimmer S, et al., (2002), Jain, Y. (2013) and Dentino AR, et al,. (2002) have notable similarities and differences along with strengths and weaknesses of which are highlighted below:

Patient group

Studies conducted by Zimmer S, et al.,(2002) and Jain, Y. (2013) had a similar size subject group of 63 and 60, respectively. However, the study conducted by Dentino AR, et al., (2002) had an overall larger subject group of 157. In terms of age ranges that were included in the studies, both Jain, Y. (2013) and Dentino AR, et al., (2002) involved subjects that were ≥ 18, and even though within Zimmer S, et al., (2002) the study the age range is not specified, we can assume this was also the case as search parameters for PubMed were set at 18-65 years. For the inclusion criteria, the percentage of teeth showing Bleeding on Probing (BOP) was used for Jain, Y. (2013) and Dentino AR, et al., (2002); however, other differing indices (such as Modified Gingival index and Papillary Bleeding Index) were also used to determine the presence of gingivitis among the study population.

Dentino AR, et al., (2002) within their sample chose to include smokers (which the other studies excluded) and confined the population to Caucasian races only.

Exclusion criteria for Dentino AR, et al., (2002) and Zimmer S, et al., (2002) was similar in that both studies rejected subjects with previous experience using powered toothbrush, this was not specified in Jain, Y. (2013)

Intervention Details

All three studies claimed to be randomized, however, only Jain, Y. (2013) actually stated the method used (a coin toss.) In addition, Both Zimmer S, et al., (2002) and Dentino AR, et al., (2002) chose to stratify subjects by gender along with plaque and bleeding indices, however the chosen stratification method was not specified in the study carried out by Jain, Y. (2013)

Supplemental plaque controls such as, interdental cleaning aids and/or mouthwashes were prohibited during the course of all three studies, in order to help control independent variables. Subjects at baseline were also given both a prophylaxis and set of oral hygiene instructions prior to the commencement of the study.

Verbal oral hygiene instructions were given in Zimmer S, et al., (2002) compared to Dentino AR, et al., (2002) in which they were written. Specification as to whether subjects received verbal or written instructions was not mentioned in the study carried out by Jain, Y. (2013)

Within the three studies the same toothpaste was given to both groups in order to maintain standardized conditions; however, in comparing the three studies all chose

8974052 17

different dentifrices: Pepsodent®, Elmex® and Crest®. However, only Zimmer S, et al., (2002) weighed the toothpastes used by the subjects; so as to determine whether toothpaste had been over or under used.

Outcomes assessed:

Zimmer S, et al., (2002) and Dentino AR, et al., (2002), both used the Turesky Modification of the Plaque Index (1970) in order to look at plaque levels to determine success. Jain, Y. (2013) differed by choosing the O’Leary plaque index (1972) to measure outcomes.

All three studies included further differing indices to measure superiority. For example, Jain, Y. (2013) included the OHI-S Green and Vermillon. (1964), Zimmer S, et al., (2002) included the API Lange et al., (1977) and PBI Mühlemann & Son (1971) indices; whereas, Dentino AR, et al., (2002), included calculus, stain and inflammation indices. Outcomes were assessed by single examiners for Zimmer S, et al.,(2002) and Dentino AR, et al.,. (2002); however, Jain, Y. (2013) failed to mention who outcome assessments were carried out by.

Jain, Y. (2013)

A disadvantage of this study was that no power calculation was shown. As there was no justification of the sample size; it becomes difficult to say, whether a sample size of 60 is a satisfactory and accurate representation of the population. However, a positive aspect of the study was that there were no withdrawals and both men and women were included.

The inclusion of dental students may have been a potential disadvantage as they are not an accurate representation of the wider population; it is likely that most of the students were aware of the correct way to brush their teeth regardless of the instructions they were given and what groups they were assigned to. The “Hawthorne effect” is also likely to of occurred in this study along with Zimmer S, et al., (2002) and Dentino AR, et al., (2002).

Males and females were said to be included within this study; however it fails to specify the female to male ratio; making it difficult to distinguish whether the study as a whole was female/male heavy, or if within the two groups one group was more female/male heavy.

An advantage of this study was that it was randomised and the method was shown; removing any investigator bias. Yet, in the same token the chosen coin toss method is a disadvantage as it may produce high unpredictability. Alternatively, using a computer to carry out randomisation would have reduced any potential for bias. In addition, the study was double-blinded; helping to reduce the potential for operator and patient bias.

Furthermore, the p-value was set at 0.05 and t-tests were used in order to calibrate the statistical significance of data. A further advantage was that the author reported no conflicts of interest.

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Although an effort was made to keep all independent variables the same; giving all subjects the same toothpaste (Pepsodent®) There was no mention of how much toothpaste should be used by the subjects; therefore, patients could have over/under used the toothpaste; potentially causing lower plaque levels and a reduction in gingivitis in one group compared to the other.

To rectify this, the specific amount of toothpaste required for use could have been specified at the beginning of the trial and/or toothpaste could have been weighed during and/or after the trial was completed; as was done by Zimmer S, et al., (2002)

Zimmer S, et al., (2002)

Like Jain, Y. (2013) no power calculation was shown; therefore, a total sample size of 63 (one excluded from analysis) is potentially too small to be representative. In addition, a confidence interval was not included within the study; this was also the case in Jain, Y. (2013) and Dentino AR, et al., (2002)

At the beginning of the study, there was an equal male to female ratio, however, it was not clear which group the excluded subject was from and whether they were in fact female/male.

In terms of intervention the randomisation procedure used was stratification by age, sex and papillary bleeding index; this is advantageous as it ensures similarity between the two groups. Again, no further explanation was given as to how randomisation took place.

The researches maintained independent variables such as toothpaste well; all subjects were provided with the same toothpaste Elmex®; this was also weighed at the end of the study to identify over or under use. The median toothpaste use for the manual group was 61.9g and 72.0g for the powered toothbrush; which could be regarded as a potential amplification of results in favour of the electric toothbrush.

For key results, the p-value was set at 0.001 and both the Mann-Whitney U-test and Friedmann test were used for non-parametric unrelated and related samples. Intra examiner reliability was also tested with repeated measurements, which can be seen as an advantage to the study. Yet, in the same token the study was carried out by a single examiner, increasing risk of bias.

Like Jain, Y. (2013) and Dentino AR, et al., (2002) it again becomes questionable whether the subjects of this study were victim to the “Hawthorne Effect;” exaggerated brushing could have occurred in the days leading up to examination.

Furthermore, the study conducted by Zimmer S, et al.,(2002) was funded by Sonex Deutschland; the overall outcome of the study suggests the superiority of the powered Ultra Sonex Ultima over the manual toothbrush; opening up speculation of funding bias.

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Dentino AR, et al., (2002)

The study conducted by Dentino AR, et al., (2002) had a larger sample size (157 subjects) than Jain, Y. (2013) and Zimmer S, et al., (2002); even though 15 failed to complete the trial. An advantage of the study done by Dentino AR, et al., (2002) compared to Jain, Y. (2013) and Zimmer S, et al., (2002) was that a power calculation of 80% had been carried out; to allow a detection of a true difference between the two treatment groups. This study was also carried out for the longest period of time (6 months), compared to the other two studies appraised, increasing the validity of the study.

The patient group, like Jain, Y. (2013) required subjects to be at least 18 years old, however, in comparison Dentino AR, et al., (2002) chose to include patients over the age of 44. By including older patients (who are potentially less manually dexterous) the study conducted by Dentino AR, et al., (2002) is able to represent a more diverse range of ages better.

A disadvantage of the study was the inclusion of smokers; which were not included in Jain, Y. (2013) and Zimmer S, et al., (2002) With the inclusion of smokers there is a danger of inaccurately reporting a reduction in bleeding on probing as well as inflammation and erythema, due to the vasoconstrictive properties of smoke.

Members of the same household were included in this study; the members were also given the same toothbrush; these subjects may have influenced each other throughout the study, potentially skewing results.

A Periodontist carried out screening and potential subjects were required, (as in Jain, Y. (2013) to have at least 20% or more sites with bleeding on probing; confirming all subjects entered the study with gingivitis. A further advantage to the study was that patients were randomised by stratification using a computer (gender, MGI, plaque index and smoking) however, as was the same in Zimmer S, et al., (2002), there was no specification on how randomisation was carried out.

The study conducted by Dentino AR, et al., (2002) used more clinical parameters than the other two studies to test the superiority of one group over the other, as the clinical question was also researching the safety of the toothbrushes, however, these will not be discussed. Dentino AR, et al., (2002) in comparison to Jain, Y. (2013) and Zimmer S, et al., (2002) chose to look at stain, calculus and inflammation. However, the inclusion of the Claydon Stain Index could be seen as a disadvantage as it is of little significance; subjects could have entered the trial with stain variability.

This study was a single blinded and single examiner study; meaning there was potential for bias. In order to compare outcomes between and within the two groups a number of statistical analyses were carried out such as, analysis of variance (ANOVA,) analysis of covariance (ANCOVA) and paired t-tests; the p-value was also set at 0.05.

Lastly, the study was supported by Braun® and Oral-B® questioning the potential for funding bias.

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Conclusion:

All three studies appraised were similar in patient grouping, study design, and concluding results; statistically significant differences in levels of plaque existed when comparing electric toothbrushes to manual toothbrushes.

However, there were a number of problems with the three studies; such as funding and sample size that reduce the studies’ integrity. Even though, the Cochrane review conducted by Yaacob et.al.,( 2014) conclusively decided that powered toothbrushes were in fact better than manual toothbrushes in terms of oral health, the inclusion criteria for the systematic review differed from those included within this critically appraised topic. Moreover, Yaacob et.al.,( 2014) suggested within the Cochrane review that results from the studies included were of “moderate quality;” suggesting that further trials are needed to be able to confidently implement change within clinical practice.

7) Implications for Future Practice and Research

Clinical practice

As mentioned before; the current advice given by “Delivering Better Oral Health” (2014) on reducing plaque induced diseases, (e.g. gingivitis) fails to specify which out of a powered and manual toothbrush should be chosen by the patient. Instead, emphasis is placed on the importance of twice daily self-care over professional cleaning, and stresses the importance of brushing the ‘Gum line.’

Furthermore, the findings of the three systematic reviews appraised, correlate to the systematic review done by Yaacob et.al. (2014); electric are more effective than manual toothbrushes regarding to oral health. However, as was discovered in Dentino AR, et al., (2002), Jain, Y. (2013) and Zimmer S, et al., (2002); evidence used to draw conclusions from the research trials used were of “moderate quality.” Yaacob et al., ( 2014) Due to many factors, there is not ‘high quality evidence’ from Dentino AR, et al., (2002), Jain, Y. (2013) and Zimmer S, et al., (2002) to support the superiority of manual toothbrushes over powered toothbrushes with the set inclusion criteria.

For example, two out of the three RCT’s appraised used products from oral health companies which actually funded the research (Braun®, Oral-B®, Sonex®.) As marketed electric toothbrushes are generally more expensive than conventional manual toothbrushes, oral health companies who market the powered toothbrushes, such as Braun®, may have a particular interest in results favouring that particular intervention group.

Moreover, small sample sizes, absences of power calculations and the inability to control independent variables; (such as toothpaste use and brushing times) reduces the quality of the evidence shown, even though it was shown to be statistically significant. Evidently, this suggests the need for more high quality evidence regarding the superiority of powered over manual toothbrushes in reducing plaque associated diseases.

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Research

As mentioned, an additional study is required in order to rectify weaknesses highlighted in the three appraised studies; in order to produce a study with robust evidence. Strengths from the three studies will be integrated as well as improvements; this may be done in the following ways:

Patient sampling should look to exclude dental students and ensure the stratified sample is actually representative of the population, perhaps by giving more consideration to the inclusion of more races and not just age and sex. All independent variables (e.g. toothpaste) in the study should be controlled more efficiently by weighing the toothpaste in order to regulate over/under use.

A statistician should be employed to determine power calculations so as to ensure an adequate sample size; to see statistically significant differences. Furthermore, a 6 month study should be regarded as minimum.

Lastly, in order to have no conflicts of interest, an independent funding source should be sought.

8) Research Protocol

Title ‘Are electric toothbrushes more effective in reducing plaque than manual toothbrushes?’

Aim To determine whether electric toothbrushes are more effective in reducing plaque induced diseases (such as gingivitis/periodontitis) and improving overall oral health than manual toothbrushes

Null hypothesis Electric toothbrushes are no more effective in reducing plaque than manual toothbrushes

Ethical Approval Approval will be sought from the local ethics committee prior to commencement of the study

Study Design

Study type:

A 6 month, double-blinded/single-blinded, parallel, stratified randomized controlled trial

Inclusion Criteria:

At least 20 fully-erupted permanent teeth 18-65 years of age No Implants or orthodontic patients of any kind Medically healthy patients with no impairments other than an established gingival

disease

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At least 20% or more sites with BOP and or/ PI (Quigley-Hein Plaque Index 1962) per tooth ≥ 2.0

Exclusion Criteria:

Severe periodontal disease Smokers Patients with any previous experience of a powered toothbrush Subjects from the same households

Sampling:

Recruitment of adults aged 18-65 years, will take place from hospitals and dental practices within the UK.

No subjects from same households Both males and females included, as well as different races. A statistician will carry out a power calculation of 80% to see a 0.05 statistically

significant difference

Treatment Protocol:

Patients will be randomised by stratification in a double-blind fashion (age, sex, race and plaque indices) into two treatment groups using a recognized computer randomisation program.

Group A will be given an electric toothbrush, while Group B will be given a manual toothbrush.

All independent variables will be controlled and accounted for.

Outcomes measured:

*Dual examiner, measured at baseline, three and six months.

1. Turesky modification (1970) of the Quigley-Hein Plaque index (PI) calculated using a registered disclosing solution

2. Percent of sites with Bleeding on Probing (BOP): Using a UNC probe and a dichotomous index on 6 sites per tooth, 30 secs after probing (bleeding present/absent)

Analysis of results

Statistical tests will be used in order to determine statistical significance of outcomes:

t-tests ANCOVA ANOVA: will be used for comparisons of treatment groups in regards to age,

gender, sex and race 95% confidence interval levels

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p value (0.05)

Resource requirements and budget

An independent sponsor will be sought out so as to have no conflicts of interest

Time frame

Six months

Expected outcome

Electric toothbrushes will prove superior to manual toothbrushes in reduction of plaque levels

Dissemination of results

Results and evidence form the study will be appraised appropriately and changes implemented in practice as necessary

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