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EFFICACY OF BIOGRAFT (β TRICALCIUM PHOSPHATE) IN ALVEOLAR RIDGE

PRESERVATION – A RANDOMIZED CONTROLLED CLINICAL STUDY’’

Authors and Affiliations:

1. Dr. Mohit Rana , Post graduate student , Department of Oral and Maxillofgacial Surgery,

Faculty of Dental Sciences, M.S Ramaiah University of Applied Sciences, Ph no.

9990169709, mohit.vipulc@gmail.com

2. Dr. R. M Lalitha, Senior Professor, Department of Oral and Maxillofgacial Surgery,

Faculty of Dental Sciences, M.S Ramaiah University of Applied Sciences, Ph no.

9448460933, drrmlalitha@gmail.com

3. Dr. Vineeth Kumar, Reader, Department of Oral and Maxillofgacial Surgery, Faculty of

Dental Sciences, M.S Ramaiah University of Applied Sciences, Ph no. 9620100084,

drvineethk@gmail.com

4. Dr. Abhishek Nandavar, Post graduate student , Department of Oral and Maxillofgacial

Surgery, Faculty of Dental Sciences, M.S Ramaiah University of Applied Sciences, Ph

no. 9986946461, abhishek_0726@yahoo.com

5. Corresponding author contact information - Dr. Mohit Rana , Post graduate student ,

Department of Oral and Maxillofgacial Surgery, Faculty of Dental Sciences, M.S

Ramaiah University of Applied Sciences, Ph no. 9990169709, mohit.vipulc@gmail.com

Word count: 2135

Number of photographs:3

Photograph captions: Figure 1: Placement of graft in extraction socket

Figure 2: Vista scan images: immediately after extraction (A)

: 6th month postoperatively (B)

Graph 1: Age distribution among with and without graft groups

Graph 2: Gender distribution among with and without graft group

Graph 3: Comparison of mean changes (post –pre) parameter values in with and without graft

group

Number of tables:1

Table captions: Table 1: Comparison of parameters (post-pre) in study groups with and without

graft

Key words: Alveolar ridge preservation, Guided Bone Regeneration, Collagen Membrane,

Synthetic bone substitute, Beta tricalcium phosphate, allograft.

ABSTRACT

PURPOSE: The purpose of this study is to evaluate the efficacy of biograft (ß tricalcium

phosphate) in alveolar ridge preservation.

MATERIALS AND METHODS: Patients requiring tooth extraction except the third molars

and who agreed for bone grafting were selected for the study. Randomly these were divided into

two groups, one was the socket preservation group in which after extraction, bone graft (

β−tricalcium phosphate) was placed in the extraction socket and protected with a collagen

membrane and the other was a control group wherein no graft was placed and extraction socket

was left to heal normally. Radiographic height and width was assessed, at time of extraction and

6 month postoperatively using vista scan and bone calliper. .

RESULTS: β - TCP placed at the time of grafting extraction socket was well tolerated in all

sites with barrier membrane used. There was no incidence of graft rejection or infection. The

reduction in the height and width of alveolar bone at the end of 6 months showed lesser

reduction in Group 1(with graft) as compared to Group 2( without graft) with a P value of <

0.001 in horizontal width measurement which is considered to be strongly significant.

CONCLUSION: Guided Bone Regeneration is a successful method of alveolar ridge

preservation and that synthetic bone substitute (β- TCP) with a collagen membrane can be

usefully utilized for this purpose.

(3) Manuscript Text Document

1. INTRODUCTION

Alveolar bone seems to play a key role in providing support to the teeth. Tooth extraction leads

to typical bone deficiency of ridge width and height of alveolar crest and reduces the possibility

of placing screw titanium implants. The bone resorption process is initiated immediately after

extraction, leading to an average 40–60% decrease in the horizontal and vertical dimensions of

the alveolar ridge, during the first 2 years 1

To restore alveolar bone loss and support efficient placement of dental implants, many different

bone substitute such as autografts, allografts, xenografts, synthetic biomaterials and osteoactive

agents have been proposed2.

Morbidity of donor sites, attempts at reduction in the number of surgical sites, and limitations in

amount of bone available are some objective reasons driving the search of bone substitute to

replace the use of autogenous bone.

Ridge preservation using the Guided Bone Regeneration (GBR) technique has been shown to

improve ridge height and width dimensions when compared with tooth extraction alone3. The use

of bone grafts in the maxillofacial region has been considered for regeneration of bone defects

and to re-establish the original skeletal contour and function.

According to previous studies ß TCP shows great osteoconductive potential because of its

macroporosity (1 micron -1000 micron), which leads to good bone growth. Approximately 90%

of this material is interconnected void spaces. ß TCP bonds directly to bone, which facilitates

healing4.

Therefore, in our study we are using Beta Tricalcium Phosphate (β-TCP) with a resorbable

collagen membrane. The present study was carried out to evaluate the alveolar ridge preservation

achieved following tooth extraction with or without the placement of β-TCP.

2. MATERIALS AND METHODS

30 Patients aged between 18-50 years, irrespective of sex reported to the Dept. of Oral and

Maxillofacial Surgery, M.S. Ramaiah Dental College and Hospital, Bangalore for the extraction

of teeth were included in the study. Each was given numbers and odd and even numbers were

selected. Randomly these were divided into 2 groups of 15 cases each, one was the experimental

group i.e. the socket preservation group in which after extraction, bone graft (β tricalcium

phosphate) was placed in the extraction socket and covered with a collagen membrane

(collagen), and the other was a control group wherein no graft was placed and extraction socket

was left to heal normally. All patients were followed up for a period of 6 months. Alveolar

height and width of both groups was assessed at post extraction / 7 th day and 6th months

respectively.

2.1 INCLUSION CRITERIA:

Patients with ASA I (Healthy patient without any systemic disease), tooth indicated for

extraction and extraction socket with four intact walls after extraction of tooth were included in

study.

2.2 EXCLUSION CRITERIA:

Patients with presence of any chronic systemic disease like diabetes, hypertension, bleeding

disorder etc. that contraindicate surgical treatment, allergic to local anesthesia or adrenaline,

undergoing chronic treatment with any medication known to affect bone turnover like heparin,

cyclosporine, bisphosphonates, chemotherapeutic drugs – methotrexate etc., pregnant or lactating

women and heavy smokers (a smoker with cigarettes consumption more than 20 pieces per day).

2.3 MATERIALS USED:

βTCPbiograftWith granule size 250-350 microns was used as bone graft material. Collagen

Membrane as barrier over graft. 3-0 Black braided silk sutures were used for primary closure.

Informed consent was taken prior to surgery.

2.4 SURGICAL PROCEDURE:

Atraumatic tooth extractions were performed using periosteal elevators and forceps under local

anaesthesia (lignocaine 2% with epinephrine 1:2, 00,000).Site preparation was accomplished

with fine curettes by removing granulation tissue followed by irrigation with saline.

Vista scan image of tooth was taken and horizontal (a straight line joining the CEJ of anterior

tooth to the CEJ of posterior tooth adjacent to extracted socket drawn) and vertical height (a

straight line joining the CEJ of anterior tooth to the CEJ of posterior tooth adjacent to extracted

socket drawn, from centre of horizontal line a straight line drop to the crest of alveolar ridge)

were measured. Buccolingual ridge width was measured using bone calliper (placing its tip one

on buccal side and other on lingual side at upper bone level and on most central part of alveolar

ridge)

The Bone graft material was dispensed from its container into a sterile stainless-steel kidney tray

and placed and packed into the socket until it filled the socket space (Figure 1). Collagen

membrane was placed over the grafted site and closure was done with 3-0 silk suture.

Postoperative instructions were given.

Postoperatively the alveolar bone height and width of both groups were assessed (using vista

scan) and compared with the pre surgical values respectively (Figure 2). The reduction in the

ridge dimensions were evaluated and compared.

Univariate analyses of the dichotomous variables encoded was performed by means of the Chi

square test with Yates correction and Student “t’ test was used to determine whether there was a

statistical difference between male and female subjects in the parameters measured.

3. RESULTS

30 patients divided into two groups - GROUP 1 (with graft) consisting of 15 patients and the

GROUP 2 (without graft) consisting of 15 patients were included in study. The patients were

aged between 18 and 50 years with mean age of 31.4 ± 7.029 years in group 1 and 31.87 ± 7.463

years in group 2. (Graph 1)

Among the 30 patients 18 (60%) were male and 12 (40%) were females, the two groups

suggesting an equal distribution of both genders in the study groups (Graph 2)

Preoperative and postoperative (after 6 months ) comparison of mean value of parameters ;

buccolingual width pre - 9.00 mm and post – 8.30 mm, horizontal width pre - 9.25 mm and post

8.95mm and vertical height pre –1.94 mm and post -2.03mm in group 1 (with graft) showed

slight decrease in alveolar ridge dimensions that were comparable to Preoperative and

postoperative (after 6 months ) comparison of mean value of parameters in group 2 (without

graft) ; buccolingual width pre : 10.067 mm and post : 9.233 mm, horizontal width pre : 9.600

mm and post: 8.933mm and vertical height pre : 1.540 mm and post : 1.400mm .

Comparison of parameters (post-pre) in study groups with and without graft showed

Buccolingual width in group 1: - 0.700 ± 0.0254 mm, Group 2: - 0.833 ± 0.748 mm

P value: 0.519, Horizontal width in group 1: - 0.293 ± 0.202, Group 2: - 0.607 ± 0.179 mm

P value :< 0.001, Vertical height in group 1: 0.087 ± 0.074mm Group 2: 0.140 ± 0.074 mm

P value: 0.058. (Graph 3, table 1)

P value of < 0.001 in horizontal width measurement showed that use of β-tcp in alveolar ridge

preservation was statistically significant. No incidence of infection or dehiscence occurred

4. DISCUSSION

Characteristic of ideal bone replacement graft material include safety, efficacy and ability for the

graft material to be replaced by vital alveolar bone. The β tcp graft material used in this study

was purely synthetic material6, osteoconductive7 in nature and has no organic components,

therefore no chance of antigenicity or allergic reaction. Compared with autogenous bone

grafting, this synthetic graft has unlimited availability without second site morbidity8.

Contrary to GTR procedures, additional bone grafting materials for space maintenance, tend to

improve GBR outcomes9 .In this study, we used Guided bone graft augmentation (GBGA)10

which designates a barrier membrane application to help preserve and maintain the bone graft ,

based on principle of osteopromotion11.

Bone substitutes were able to preserve post extraction alveolar ridge dimensions to some extent,

the quantity and the quality of the bone tissue formed in the socket have been variable and their

presence often interfered with the normal healing process 12. But in this study, quantity and

quality of bone formed was good with trabecuale resembling adjacent natural bone and there

were no cases of infection and dehiscence. Healing was satisfactory and uneventful.

Post-extraction alveolar ridge resorption was observed in previous randomized controlled clinical

trials where extraction sockets were treated with either β tcp4, a combination of HA and β-TCP

bone graft and a collagen membrane13 or porcine xenograft and a collagen membrane14. Also, in

a study healing of extraction sockets filled with freeze – dried bone and collagen membrane was

compared with the healing of “empty” untreated extraction sockets15

In study, both pre and postoperative radiographic measurements on Vista scan were taken from

the Cemento-enamel junction of the adjacent mesial tooth to Cemento-enamel junction of the

adjacent distal tooth to the corresponding highest Alveolar bone crest level. The results clearly

showed less dimensional change in horizontal width, vertical height and buccolingual width in

Group 1 patients which indicate decreased bone resorption as compared to more resorption in

Group 2 patients over a period of six months post operatively. Horizontal width measurement

with p value <0.001 gave statistically significant result.

One of the advantages of our study is the presence of a negative control group in which

unassisted socket healing was observed for a similar period of time in the patient where socket

preservation procedure was carried out. The limitation of the present study was that the sample

size was small consisting of 15 patients and histological evaluation was not performed for all the

treated sites which would have given us a clear picture of bone formation.

5. CONCLUSION

β tricalcium phosphate is a bio graft material, resorbable, osteoconductive in nature, economical,

with minimal rejection and no donor site morbidity. Collagen membrane is resorbable in nature.

In the present study we used combination of β tcp and collagen membrane. It gave significant

results with regard to preservation of horizontal width of the socket and also helped in

preservation of buccolingual width and vertical height.

Hence use of β tcp and collagen membrane is viable option after routine extraction of tooth.

However the limitation of this study is small sample size, hence long term study with a larger

sample size is recommended.

Product IdentificationIFGL Bio Ceramics Ltd

Manuscript References

1. Ashman A. Post extraction ridge preservation with synthetic alloplast. Implant dentistry

2000; 9(2):168-176.

2. Nevins, M., Camelo, M., De Paoli, S., Friedland, B., Schenk, R. K., Parma Benfenati, S.,

Simion, M., Tinti, C. &Wagenberg, B. A study of the fate of the buccal wall of extraction

sockets of teeth with prominent roots. International Journal of Periodontics & Restorative

Dentistry 2006 ; 26: 19–29

3. Lekovic, V., Kenney, E., Weinlaender, M., Han, T., Klokkevold, P., Nedic,

M. &Orsini, M. A bone regenerative approach to alveolar ridge maintenance following

tooth extractions. Report of 10 cases. Journal of Periodontology 1997; 68:563–570

4. Horowitz RA, Mazor Z, Miller RJ, Krauser J, Prasad HS , Rohrer MD . Clinical

evaluation of alveolar ridge preservation with a beta-tricalcium phosphate socket graft.

Comp Cont. Educ dent (Jamesburg, N.J.: 1995) 30(9):588-90, 592, 594 passim; quiz 604,

606.

5. Nevins, M., Camelo, M., De Paoli, S., Friedland, B., Schenk, R. K., Parma Benfenati, S.,

Simion, M., Tinti, C. &Wagenberg, B. A study of the fate of the buccal wall of extraction

sockets of teeth with prominent roots. International Journal of Periodontics & Restorative

Dentistry 2006 ; 26: 19–29

6. Tadic, M. Epple. A thorough physicochemical characterisation of 14 calcium phosphate-

based bone substitution materials in comparison to natural bone. Biomaterials 2004; 25:

987–994

7. Luvizuto ER1, Queiroz TP, Margonar R, Panzarini SR, Hochuli-Vieira E, Okamoto T,

Okamoto R.Osteoconductive properties of β-tricalcium phosphate matrix, polylactic and

polyglycolic acid gel, and calcium phosphate cement in bone defects. J Craniofac Surg.

2012 Sep;23(5):e430-3.

8. Ehrler DM, Vaccaro AR: The use of allograft bone in lumbar spine surgery.

Clin Orthop Relat Res 2000, 1:38–45

9. Callan D P, Rohrer M D, Use of bovine-derived hydroxyapatite in the treatment of

edentulous ridge defects: a human clinical and histological case report. Journal of

Periodontology, 1993; 64(6):575-82.

10. Daniel van S, Reinhilde J., Clinical procedures of guided bone augmentation. In Philip J

Boyne(ed): Alveolar ridge augmentation/ Guided tissue regeneration and Bone grafting.

W B Saunders Company, Philadelphia, 2001; 479.

11. Güven O1, Tekin US Healing of bone defects by an osteopromotion technique using

solvent-dehydrated cortical bone plate: a clinical and radiological study. J Craniofac

Surg. 2006 Nov; 17(6):1105-10.

12. Nikolaos Donos. Alveolar ridge preservation with guided bone regeneration and a

synthetic bone substitute or a bovine-derived xenograft: a randomized, controlled clinical

trial. Clinical Oral Implants Research.2010; 21(7):688-98

13. Mardas N, Chadha V, Donos N. Alveolar ridge preservation with guided bone

regeneration and a synthetic bone substitute or a bovine-derived xenograft: a

Randomized controlled clinical trial. Clin Oral Implants Res. 2010 Jul; 21(7):688-98.

14. Barone A et al. Xenograft versus extraction alone for ridge preservation after tooth

removal: a clinical and histomorphometric study. Journal of Periodontology 2008; 79(8):

1370-1377.

15. Iasella J M ,Ridge preservation with freeze dried bone allograft and a collagen membrane

compared to extraction alone for implant site development: A Clinical and histologic

study in Humans” Journal Of Periodontology 2003;74(7):990-999.

(4) Photographs

FIGURE

Figure 1

Placement of graft in extraction socket

(A) (B)

Immediately after extraction 6th month postoperatively

Figure 2

(5) Tables, Figures, Diagrams, Artwork

GRAPH

Graph 1

Age distribution among with and without graft groups

Graph 2

Gender distribution among with and without graft group

Graph 3

Comparison of mean changes (post –pre) parameter values in with and without graft group

TABLE

    N Mean SD Min. Max. ‘t’

value

‘p’

value

Buccolingual

Width

With

Graft

15 -0.70 0.254 -1 -0.5 0.427 0.519

Without

Graft

15 -0.83 0.748 -2 1

Horizontal

width

With

Graft

15 -0.29 0.202 -0.7 0 20.24 <0.001

Without

Graft

15 -0.61 0.179 -1 -0.3

Vertical

Height

With

Graft

15 0.09 0.074 0 0.2 3.896 0.058

Without

Graft

15 0.14 0.074 0 0.3

Table 1

Comparison of parameters (post-pre) in study groups with and without graft