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<ul><li><p>The</p><p>Journal ofClinical Dentistry</p><p>THE INTERNATIONAL JOURNAL OF APPLIED DENTAL RESEARCHwww.JClinDent.com</p><p>Volume XVII 2006 Number 3</p><p>SENIOR EDITORRobert C. Emling, EdD</p><p>EDITORIAL BOARDMartin Addy, BDS, MSc, PhD, FDSRCSJoln Bnczy, MD, PhD, DScCaren M. Barnes, RDH, MSAugusto R. Elias Boneta, DMD, MSDAnnerose Borutta, Prof.Dr.med.habil.Robert L. Boyd, DDS, MEdKenneth H. Burrell, DDS, MSMark E. Cohen, PhDWilliam Michael Edgar, PhD, DDSc,FDSRCSDenise Estafan, DDS, MSJohn D.B. Featherstone, MSc, PhDRalph P. Feller, DMD, MS, MPHStuart L. Fischman, DMDRosa Helena Miranda Grande, DDS, PhDJohn J. Hefferren, PhDElliot V. Hersh, DMD, PhDMark E. Jensen, DDS, PhDCarl J. Kleber, MSD, PhDIsrael Kleinberg, DDS, PhD, DScKarl F. Leinfelder, DDS, MSJohn H. Manhold, MA, DMDJonathan Mann, DMD, MScMilton V. Marshall, PhD, DABTPier Francesco Porciani, MD, MScDHoward M. Proskin, PhDMark S. Putt, MSD, PhDBruce R. Schemehorn, MSWarren Scherer, DDSThomas Schiff, DMDCharles M. Schoenfeld, DDS, PhDPramod M. Soparkar, BDS, DMD, MSJon B. Suzuki, DDS, PhD, MBAJason M. Tanzer, DMD, PhDWei-Ming Tay, BDS, FDS, PhDNorman Tinanoff, DDS, MSHenry O. Trowbridge, DDS, PhDRichard I. Vogel, DMDJames S. Wefel, PhDWayne T. Wozniak, PhDStefan Zimmer, Priv.-Doz. Dr. med. dent.Samuel L. Yankell, MS, PhD, RDH (Chair) </p><p>PUBLISHERStephen M. Siegel</p><p>The Journal of?Clinical Dentistry (ISSN 0895-8831) is published by Professional Audience Communications, Inc., P.O. Box 243, Yardley, PA 19067.POSTMASTER; Send address changes to P. O. Box 8, Moorestown, NJ 08057.Copyright 2006 by the YES Group, Inc. All rights reserved. No part of this publication may be reproduced without written permission from the publisher.</p><p>Reprint</p><p>Interproximal Gingivitis and Plaque Reductionby Four Interdental Products</p><p>Kevin G. Yost, PhD</p><p>Sunstar Americas, Inc.Chicago, IL, USA</p><p>Mark E. Mallatt, DDS, MSD</p><p>Indiana State Department of HealthIndianapolis, IN, USA</p><p>Joanne Liebman, RDH, MEd</p><p>Hill Top ResearchWest Palm Beach, FL, USA</p></li><li><p>Abstract Objective: The study was conducted to compare the performance of three interdental products to dental floss in the control and</p><p>removal of plaque, and in the reduction of gingivitis. Methodology: One-hundred and twenty subjects were screened for the presence of interproximal sites of a size suitable for a GUM</p><p>Go-Betweens cleaner, and for being in compliance with inclusion and exclusion criteria. They were then assessed with thePlaque, Gingivitis, and Eastman Interdental Bleeding Indices (EIBI) at baseline, given a prophylaxis, randomly assigned to one offour products (Glide dental floss, Butler flossers, GUM Go-Betweens cleaners, and GUM Soft-Picks cleaners), and givenproduct use instructions. Subjects returned at three weeks for a compliance review and at six weeks for a final visit. Plaque wasassessed at the final visit before and after using the assigned products. Plaque, gingivitis, and bleeding scores were evaluated byanalysis of covariance using the baseline measurements as the covariate.</p><p> Results: All four interdental products significantly reduced interdental plaque from baseline to before-use at the final visit (aftersix weeks) employing baseline plaque as a covariate. Reductions were 16% to 24%. Similarly, use of the products at the final visitresulted in 26% to 31% reductions in plaque with the before-use plaque as a covariate. Interdental gingivitis scores showed a reductionboth lingually and buccally, with reductions ranging from 27% to 36% for the former and 34% to 53% for the latter (baseline wasthe covariate). No statistical differences were found between the products on the lingual interdental sites. The Go-Betweens clean-ers showed a statistically greater reduction in the Gingival Index score buccally than the other three products. No differences werenoted among the products for the EIBI.</p><p> Conclusion: In this study, dental floss, the recognized gold standard for gingivitis reduction, was matched in performance byflossers and an interdental cleaner with small elastomeric fingers, and surpassed by an interdental brush. All products performedcomparably for plaque reduction and removal. </p><p>(J Clin Dent 17:7983, 2006)</p><p>79</p><p>IntroductionToothbrushes are the primary and most frequently used tool</p><p>for maintaining good oral hygiene. About 98% of Americansuse a toothbrush to clean their teeth. However, tooth brushing isnot enough. With a good design and careful technique a tooth-brush can clean into the embrasure, the open and easily accessi-ble area between teeth. Toothbrush bristles cannot properly pen-etrate under the contact and thoroughly clean interproximalspaces.1</p><p>It has long been known the most severe gingivitis occurs inter-proximally.2 Mechanical cleaning has even been found to per-form better than chemical treatment in reducing gingivitis.1 TheAmerican Dental Association recommends the use of dentalfloss for complete between-teeth cleaning. By disturbing andremoving plaque, flossing has become the standard of care sinceit reaches the area where gingivitis starts and is often missedwhen brushing. Traditional dental floss is not easy to use, how-ever, presenting a barrier to achieving good oral care to those withreduced dexterity or an inability or unwillingness to devote timeto the flossing procedure.</p><p>Alternatives to traditional floss include single-use flossers andinterdental brushes. Previous studies have examined the plaqueremoval capabilities of interdental brushes to floss with varyingresults.3-7 In particular, Yamamoto, et al.4 found the addition offlossing to brushing resulted in an increase in plaque removal, andthe use of an interdental brush with regular brushing removedeven more plaque. This study compared the plaque removal andgingivitis reduction capabilities of a flosser, a fine, small-diame-ter, interdental brush, and an interdental cleaner with small syn-thetic rubber fingers, to those of traditional dental floss.</p><p>Materials and MethodsStudy Population</p><p>Study participants were chosen from an urban and suburbanpopulation in Florida. A total of 154 subjects were screened andsigned the consent form, with 128 meeting all the study criteriato be enrolled and randomized. An additional eight subjectswere dropped after randomization with the remaining 120subjects completing the study. A summary of the demographicsappears in Table I.</p><p>Interproximal Gingivitis and Plaque Reduction by Four Interdental ProductsKevin G. Yost, PhD</p><p>Sunstar Americas, Inc.Chicago, IL, USA</p><p>Mark E. Mallatt, DDS, MSD</p><p>Indiana State Department of HealthIndianapolis, IN, USA</p><p>Joanne Liebman, RDH, MEd</p><p>Hill Top ResearchWest Palm Beach, FL, USA</p></li><li><p>80 The Journal of Clinical Dentistry Vol. XVII, No. 3</p><p>tips (all Sunstar Americas, Inc., Chicago, IL, USA). Flossersconsist of a short piece of floss held between tines of a device forsingle-use flossing. The Go-Betweens Cleaners interdentalbrushes have a handle molded around the twisted wire of a smallcylindrical brush. The Soft-Picks interdental cleaners resemblethe brushes, but do not have metal or fiber bristles. Instead, theyhave small elastomeric fingers protruding perpendicularly froma plastic core. Subjects were also provided Crest Regular tooth-paste (Procter &amp; Gamble, Cincinnati, OH, USA) and GUM</p><p>430 soft toothbrushes (Sunstar Americas, Inc., Chicago, IL, USA).There was no negative control.</p><p>Statistical analysis was performed using JMP 3.2 (SAS Insti-tute Inc., Cary, NC, USA) software.</p><p>ResultsNot all sites in the subjects mouths were considered suitable</p><p>for the study since the interproximal areas needed to be acces-sible to all of the types of products tested. Figure 1 shows the fre-quency of sites meeting this criterion in the maxilla andmandible. As would be expected, sufficiently accessible siteswere more frequently found toward the back of the mouth, al-though missing teeth reduced the number of posterior sites.</p><p>For plaque, the within-treatment analyses were conducted uti-lizing Students t-test for paired data to evaluate the changes frombaseline to before-use at the final visit. The same method wasused to compare the before-use plaque levels at the final visit tothe after-use levels at the final visit (Table II, Figure 2). Those re-sults indicated statistically significant changes for all productstested. </p><p>The between-treatment analyses were conducted with ananalysis of covariance, using the baseline plaque level as the co-variate for the analysis of mean change from baseline, and theplaque level at the final visit before-use as the covariate for thechange at the final visit from before- to after-use. The results ofthose analyses indicated no significant differences between treat-ments (Table III).</p><p>Within-treatment analyses of gingivitis changes from baselineto the final visit using the Students t-test for paired data are pre-sented in Table IV and Figures 3a and 3b. Means for the wholemouth, and separate analyses of the changes for the lingual andbuccal aspects are shown. All products showed statistically sig-</p><p>Although all four treatments are intended for cleaning of theinterproximal spaces, the products are of different sizes and fitinto different size interdental spaces. For any qualified subject touse any of the four treatments, an interproximal site in a subjectsmouth was identified for treatment if the site could accommodatethe interdental brush. To be included in the study, subjects wererequired to have at least five interproximal sites of this size withadjacent teeth being natural dentition, as well as having a meanplaque score of at least 1.5 and a mean gingival score of at least1.0. The subjects needed to have the ability to floss, though werenot to be current floss users.</p><p>Subjects were excluded if they were on antibiotic or anti-coagulant therapy, steroids, or other anti-inflammatory productswithin the previous month (acetaminophen and 81 mg dailyaspirin were not considered anti-inflammatory). Diabetes,rheumatic fever, hepatic or renal disease, gross caries or otherhard tissue pathology, other transmissible diseases, heavy cal-culus, orthodontics, prosthodontics, piercings, and allergy to redfood dye were each also a basis for exclusion.</p><p>Study ProceduresAt the baseline visit, subjects presented having refrained from</p><p>oral hygiene procedures for the previous 1218 hours. Exami-nations were performed in the order of oral soft tissue, gingivi-tis (Le and Silness Gingival Index5), plaque level (Benson mod-ification of the Quigley-Hein Index6), and interdental bleeding(Eastman Interdental Bleeding Index,7 EIBI). Subjects weregiven a prophylaxis to remove all supragingival calculus andplaque, randomly assigned one of the four test products, andgiven product use and diary instructions. Product use by thesubjects was supervised at this visit to ensure the product wasused correctly. The subject was informed of the designated in-terdental sites to be treated with the assigned product once daily. </p><p>Subjects returned at three weeks for a medical/dental historyupdate, diary and compliance review, and additional product asneeded.</p><p>At six weeks, subjects again presented at the site having re-frained from oral hygiene for 1218 hours. An oral soft tissueexam was followed by gingivitis and plaque examinations of thedesignated sites. The subjects used their assigned product in aseparate area to maintain examiner blinding, followed by a re-peated plaque exam and an EIBI assessment.</p><p>Products TestedThe four test products were Crest Glide original dental</p><p>floss (Procter &amp; Gamble, Cincinnati, OH, USA) as the positivecontrol, Butler Flossers, GUM Go-Betweens Cleaners, avery small interdental brush, and GUM Soft-Picks interden-tal cleaners, plastic cleaners with elastomeric (synthetic rubber)</p><p>Table I Study Demographics</p><p>Females: 83 Age mean and range: 39.6; 1863Males: 37 Age mean and range: 35.1; 1957</p><p>Caucasian: 71 Smokers: 12African American: 19 Non-Smokers: 108</p><p>Hispanic: 27Other: 3</p><p>Figure 1. Total number of sites found at each arch location across all subjects.</p><p>0</p><p>10</p><p>20</p><p>30</p><p>40</p><p>50</p><p>60</p><p>70</p><p>80</p><p>90</p><p>100</p><p>0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15</p><p>Tooth Number</p><p>Nu</p><p>mb</p><p>er o</p><p>f S</p><p>ites</p><p>Maxilla</p><p>Mandible</p><p>Right Side Left Side</p></li><li><p>Vol. XVII, No. 3 The Journal of Clinical Dentistry 81</p><p>nificant reductions in gingivitis, both lingually and buccally.For gingivitis, the between-treatment analyses were conducted</p><p>separately of the mean change from baseline for the lingual andbuccal sites, utilizing analysis of covariance with the baseline</p><p>gingivitis level as the covariate. The results of those analyses in-dicated no significant differences between treatments for the lin-gual sites, but a significant difference between the treatments atthe buccal sites favoring the gingivitis reduction achieved bythe Go-Betweens Cleaners (Table V). </p><p>With a statistically significant result for the analysis of co-variance for the buccal sites, the four treatments were compared</p><p>Table VAnalysis of Covariance of Gingivitis Level Changes fromBaseline to Final Visit for the Lingual and Buccal Sites</p><p>GingivitisBetween-treatment AnalysesLingual Sites</p><p>Least Squares Means (Changes from Baseline)</p><p>Flossers Glide Floss Go-Betweens Soft-Picks0.390 0.397 0.533 0.445</p><p>Analysis of Covariance p-value: Significant Comparisons:0.3016 No significant differences between products</p><p>Buccal SitesLeast Squares Means (Changes from Baseline)</p><p>Flossers Glide Floss Go-Betweens Soft-Picks0.475 0.417 0.647 0.450</p><p>Analysis of Covariance p-value: Significant Comparisons:0.0208 Go-Betweens vs. other three products</p><p>Table IIIBetween-treatment Analysis of Covariance of Plaque LevelChanges from Baseline to Final Visit Before-use, and of the</p><p>Plaque Removed at the Final Visit During Use</p><p>PlaqueBetween-treatment AnalysesLeast Squares Means Changes: Baseline to Final Visit Before-use</p><p>Flossers Glide Floss Go-Betweens Soft-Picks0.577 0.395 0.491 0.410</p><p>Analysis of Covariance p-value: Significant Comparisons:0.3375 No significant differences between products</p><p>Least Squares Means Changes: Final Visit from Before to After Use</p><p>Flossers Glide Floss Go-Betweens Soft-Picks0.619 0.540 0.558 0.506</p><p>Analysis of Covariance p-value: Significant Comparisons:0.2623 No significant differences between products</p><p>Figure 2. Whole mouth plaque levels (as Plaque Index) at baseline, at the finalvisit before product use, and at the final visit after product use. Error bars arestandard errors.</p><p>Plaque Levels</p><p>0</p><p>0.5</p><p>1</p><p>1.5</p><p>2</p><p>2.5</p><p>3</p><p>Flossers Glide Go-Betw eens Soft-Picks</p><p>Baseline</p><p>Final Before</p><p>Final After</p><p>Table IIAnalysis of Changes from Baseline Plaque</p><p>Utilizing Students t-test for Paired Data</p><p>Plaque Index</p><p>Mean t-test %Evaluation n Mean Change* p-value Change</p><p>Baseline 2.60 Flossers Before Use at Final Visit 28 1.98 0.62 &lt; 0.0001 24%</p><p>After Use at Final Visit 1.36 0.62 &lt; 0.0001 31%</p><p>Baseline 2.46 Glide Floss Before Use at Final Visit 31 2.06 0.40 &lt; 0.001 16%</p><p>After Use at Final Visit 1.51 0.55 &lt; 0.0001 27%</p><p>Baseline 2.30 Go-Betweens Before Use at Final Visit 31 1.84 0.47 &lt; 0.001 20%</p><p>After Use at Final Visit 1.29 0.55 &lt; 0.001 30%</p><p>Baseline 2.34 Soft-Picks Before Use at Final Visit 30 1.95 0.39 &lt; 0...</p></li></ul>