Efficacy of Chlorhexidine Varnish for the Prevention of Adult Caries A Randomized Trial
The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weigh...
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| Published in: | Journal of dental research Vol. 91; no. 2; pp. 150 - 155 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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Los Angeles, CA
SAGE Publications
01-02-2012
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| Online Access: | Get full text |
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| Abstract | The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v) dental coating (CHX). We excluded participants for whom the study treatment was contraindicated or whose health might affect outcomes or ability to complete the study. Participants were randomly assigned to receive either the CHX coating (n = 490) or a placebo control (n = 493). Coatings were applied weekly for 4 weeks and a fifth time 6 months later. The primary outcome (total net D1-2FS increment) was the sum of weighted counts of changes in tooth surface status over 13 months. We observed no significant difference between the two treatment arms in either the intention-to-treat or per-protocol analyses. Analysis of 3 protocol-specified secondary outcomes produced similar findings. This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for the prevention of new caries (Clinicaltrials.gov registration number NCT00357877). |
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| AbstractList | The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v) dental coating (CHX). We excluded participants for whom the study treatment was contraindicated or whose health might affect outcomes or ability to complete the study. Participants were randomly assigned to receive either the CHX coating (n = 490) or a placebo control (n = 493). Coatings were applied weekly for 4 weeks and a fifth time 6 months later. The primary outcome (total net D(1-2)FS increment) was the sum of weighted counts of changes in tooth surface status over 13 months. We observed no significant difference between the two treatment arms in either the intention-to-treat or per-protocol analyses. Analysis of 3 protocol-specified secondary outcomes produced similar findings. This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for the prevention of new caries (Clinicaltrials.gov registration number NCT00357877). The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v) dental coating (CHX). We excluded participants for whom the study treatment was contraindicated or whose health might affect outcomes or ability to complete the study. Participants were randomly assigned to receive either the CHX coating (n = 490) or a placebo control (n = 493). Coatings were applied weekly for 4 weeks and a fifth time 6 months later. The primary outcome (total net D1-2FS increment) was the sum of weighted counts of changes in tooth surface status over 13 months. We observed no significant difference between the two treatment arms in either the intention-to-treat or per-protocol analyses. Analysis of 3 protocol-specified secondary outcomes produced similar findings. This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for the prevention of new caries (Clinicaltrials.gov registration number NCT00357877). The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v) dental coating (CHX). We excluded participants for whom the study treatment was contraindicated or whose health might affect outcomes or ability to complete the study. Participants were randomly assigned to receive either the CHX coating (n = 490) or a placebo control (n = 493). Coatings were applied weekly for 4 weeks and a fifth time 6 months later. The primary outcome (total net D 1-2 FS increment) was the sum of weighted counts of changes in tooth surface status over 13 months. We observed no significant difference between the two treatment arms in either the intention-to-treat or per -protocol analyses. Analysis of 3 protocol-specified secondary outcomes produced similar findings. This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for the prevention of new caries ( Clinicaltrials.gov registration number NCT00357877). |
| Author | Maupome, Gerardo Kirk, Kelly Singh, Mabi Brooks, Leah Phipps, Kathy Peaches, Rantreva Fellows, J. Tavano, Joanne White, Alex Stevens, George Meltesen, Gayle Sundaralingam, Shankeertha Krizova, Lucie Brown, Ashley Giullion, Christina Tzavaras, Elizabeth Douglas, Mark Bardsley, Jeanette Blanchard, Peter Lee, Karen Reck, Deborah Casey, Moira Johnson, Joanne Gulati, Harish Goldtooth, Tracy Gullion, C.M. Soter, John Cleeve Dixon, Arthor Chen, Ping Massinger, Lisa Russell, David Hollis, Jack Singh, M.L. Deane, Joy-Ann Funkhouser, Kimberly Molina, Nydia Booker, Kristina Honanie, Eric Vollmer, William M. Snyder, J. Cheek, Paul Strong, Barbara Rasathurai, Sumithran Bernel, Diane Bader, James Richards, Kim Laws, R. Vollmer, W.M. Fellows, Jeffrey Blanchard, P. Ryczek, Shelli Little, Sally Jo Hankins, Janet Muessig, Kristin Clark, Donna O’Connor, Kimberly Elder, Charles Johnson, Cheryl Papas, A.S. Machen, Celeste Talayumptewa, Corina Masaquaptewa, Adrinne Olson, Ora Lee Burns, Virginia Gleason, Donna Downing, Joyce Haskie, Jacqueline Harrington, Dorothy Ragone, La |
| AuthorAffiliation | 5 Kaiser Permanente Dental Associates, Portland, OR 97227, USA 2 Kaiser Permanente Center for Health Research, 3800 North Interstate Avenue, Portland, OR 97227, USA 6 Delta Site, Oral Health Center, Westborough, MA 01581, USA 3 University of North Carolina School of Dentistry, Chapel Hill, NC 27599-7450, USA 7 See Authors’ Note for the full list 1 Tufts University School of Dental Medicine, Boston, MA 02111, USA 4 Indiana University School of Dentistry and the Regenstrief Institute, Indianapolis, IN 46202, USA |
| AuthorAffiliation_xml | – name: 6 Delta Site, Oral Health Center, Westborough, MA 01581, USA – name: 2 Kaiser Permanente Center for Health Research, 3800 North Interstate Avenue, Portland, OR 97227, USA – name: 3 University of North Carolina School of Dentistry, Chapel Hill, NC 27599-7450, USA – name: 1 Tufts University School of Dental Medicine, Boston, MA 02111, USA – name: 4 Indiana University School of Dentistry and the Regenstrief Institute, Indianapolis, IN 46202, USA – name: 5 Kaiser Permanente Dental Associates, Portland, OR 97227, USA – name: 7 See Authors’ Note for the full list |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/22156917$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Contributor | Maupome, Gerardo Kirk, Kelly Singh, Mabi Brooks, Leah Phipps, Kathy Peaches, Rantreva Tavano, Joanne White, Alex O'Connor, Julie Stevens, George Meltesen, Gayle Sundaralingam, Shankeertha Krizova, Lucie Brown, Ashley Giullion, Christina Tzavaras, Elizabeth Vollmer, William M Douglas, Mark Bardsley, Jeanette Blanchard, Peter Lee, Karen Reck, Deborah Casey, Moira Johnson, Joanne Gulati, Harish Goldtooth, Tracy Soter, John Cleeve Dixon, Arthor Chen, Ping Robertson, L D Massinger, Lisa Russell, David Hollis, Jack Deane, Joy-Ann Funkhouser, Kimberly Molina, Nydia Booker, Kristina Honanie, Eric Cheek, Paul Strong, Barbara Rasathurai, Sumithran Bernel, Diane Bader, James Richards, Kim Fellows, Jeffrey Ryczek, Shelli Little, Sally Jo Hankins, Janet Muessig, Kristin Clark, Donna Elder, Charles Johnson, Cheryl Machen, Celeste Talayumptewa, Corina Masaquaptewa, Adrinne Olson, Ora Lee Burns, Virginia Gleason, Donna Downing, Joyce Haskie, Jacqueline Harrington, Dorothy Ragone, Lauren Ganda, Kachan Torresyap, Gay Singh, Medha Johnson, Kristen Marangi-Marsden, Rose |
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| Copyright | 2012 International & American Associations for Dental Research 2012 International & American Associations for Dental Research 2012 International & American Associations for Dental Research |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-News-2 ObjectType-Feature-3 content type line 23 Alex White DDS, DrPH, MS; Peter Blanchard DDS, MBA; Joy-Ann Deane DDS; Keith Hamburger RDH; Joanne Johnson RDH; Kristen Johnson RDH; Rosemary Marangi-Marsden RDH; Nydia Molina DA; Kimberly O’Connor CDA; Joanne Tavano CDA; Gay Torresyap RDH, MS, CCRC Athena Papas DMD, PhD; Elizabeth Arkema BS; Ashley Brown BS; Virginia Burns BS, RDH; Moira Casey BS; Pamela Corrado BS; Mark Douglas DH; Kachan Ganda MD; Harish Gulati DMD; Dorothy Harrington BS; Lucie Krizova MPH; Karen Lee BS; Julie O’Connor BS, DH; Lauren Ragone BS; David Russell DMD, MPH; Medha Singh BDS, MS; Mabi Singh BDS, MS; John Cleeve Soter BS DH; George Stevens DMD; Shankeertha Sundaralingam BS, MS; Elizabeth Tzavaras DA John Snyder DMD; Diane Bernel RDH; John Brittan DMD; Leah Brooks CRSI; Jennifer Carlston CRSII; Paul Cheek; Donna Clark CRSII; Joyce Downing; Kelsie Farrell CRSII; Donna Gleason; Janet Hankins RDH; Jack Hollis PhD; Cheryl Johnson EdM; Dan LaFerriere RN; Sally Jo Little RDH; Lisa Massinger; Kristin Muessig CRSII; Ora Lee Olson RDH; Kim Richards CRSI; Craig Snyder DMD; Barbara Strong Gerardo Maupome BDS, MSc, PhD; Marilyn Begay; Tracy Goldtooth; Jacqueline Haskie; Eric Honanie; Adrinne Masaquaptewa; Junhie Oh DDS, MPH; Rantreva Peaches; Kathy Phipps PhD, DDS; L.D. Robertson MD, MPH; Shelli Ryczek RDH, BS; Corina Talayumptewa; TCRHCC officers and staff; NNHRRB officers and staff William M. Vollmer PhD; James Bader DDS, MPH; Jeanette Bardsley; Kristina Booker BS; Chuhe Chen PhD; Ping Chen MS; Arthor Dixon MS; Judy Donald MA; Charles Elder MD, MPH; Jeffrey Fellows PhD; Kimberly Funkhouser BS; Christina Giullion PhD; Kelly Kirk; Reesa Laws BS; Celeste Machen; Gayle Meltesen MS; Sumithran Rasathurai PhD; Deborah Reck |
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| References | Axelsson, Nystrom, Lindhe 2004; 31 Pitts, Fyffe 1988; 67 James, Parnell, Whelton 2010; 44 Banting, Papas, Clark, Proskin, Schultz, Perry 2000; 17 Chesters, Pitts, Matuliene, Kvedariene, Huntington, Bendinskaite 2002; 81 Slot, Vaandrager, Van Loveren, Van Palenstein Helderman, van der Weijden 2011; 45 Vollmer, Papas, Bader, Maupome, Gullion, Hollis 2010; 10 Schafer, Graham 2002; 7 Featherstone 2008; 53 Bekhuis 2011; 11 Kingman, Selwitz 1997; 25 Banting, Amaechi, Bader, Blanchard, Gilbert, Holland 2011 Forgie, Paterson, Pine, Pitts, Nugent 2000; 34 Griffin, Griffin, Swann, Zlobin 2005; 84 Cohen 1960; 20 9088693 - Community Dent Oral Epidemiol. 1997 Feb;25(1):60-8 21605831 - J Evid Based Dent Pract. 2011 Jun;11(2):84-6 22320292 - J Public Health Dent. 2011 Fall;71(4):335-44 22156916 - J Dent Res. 2012 Feb;91(2):122-4 18782377 - Aust Dent J. 2008 Sep;53(3):286-91 11808057 - Gerodontology. 2000 Dec;17(2):67-76 20606432 - Caries Res. 2010;44(4):333-40 11014911 - Caries Res. 2000 Sep-Oct;34(5):432-9 16040728 - J Dent Res. 2005 Aug;84(8):715-20 3049719 - J Dent Res. 1988 Mar;67(3):592-6 15312097 - J Clin Periodontol. 2004 Sep;31(9):749-57 20923557 - BMC Oral Health. 2010;10:23 12202647 - J Dent Res. 2002 Sep;81(9):637-40 22722412 - Evid Based Dent. 2012 Jun;13(2):45 12090408 - Psychol Methods. 2002 Jun;7(2):147-77 21525751 - Caries Res. 2011;45(2):162-73 15286115 - J Dent Res. 2004;83 Spec No C:C15-7 bibr11-0022034511424154 bibr16-0022034511424154 Cohen J (bibr7-0022034511424154) 1960; 20 bibr2-0022034511424154 bibr3-0022034511424154 bibr19-0022034511424154 Biesbrock AR (bibr5-0022034511424154) 2005 bibr8-0022034511424154 bibr13-0022034511424154 bibr15-0022034511424154 bibr17-0022034511424154 bibr6-0022034511424154 bibr4-0022034511424154 bibr12-0022034511424154 bibr1-0022034511424154 bibr10-0022034511424154 bibr9-0022034511424154 bibr14-0022034511424154 bibr20-0022034511424154 bibr18-0022034511424154 |
| References_xml | – volume: 10 start-page: 23 year: 2010 article-title: Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries publication-title: BMC Oral Health contributor: fullname: Hollis – volume: 81 start-page: 637 year: 2002 end-page: 640 article-title: An abbreviated caries clinical trial design validated over 24 months publication-title: J Dent Res contributor: fullname: Bendinskaite – volume: 20 start-page: 37 year: 1960 end-page: 46 article-title: A coefficient of agreement of nominal scales publication-title: Psychol Bull contributor: fullname: Cohen – volume: 53 start-page: 286 year: 2008 end-page: 291 article-title: Dental caries: a dynamic disease process publication-title: Aust Dent J contributor: fullname: Featherstone – volume: 44 start-page: 333 year: 2010 end-page: 340 article-title: The caries-preventive effect of chlorhexidine varnish in children and adolescents: a systematic review publication-title: Caries Res contributor: fullname: Whelton – volume: 67 start-page: 592 year: 1988 end-page: 596 article-title: The effect of varying diagnostic thresholds upon clinical caries data for a low prevalence group publication-title: J Dent Res contributor: fullname: Fyffe – volume: 34 start-page: 432 year: 2000 end-page: 439 article-title: A randomised controlled trial of the caries-preventive efficacy of a chlorhexidine-containing varnish in high-caries-risk adolescents publication-title: Caries Res contributor: fullname: Nugent – volume: 31 start-page: 749 year: 2004 end-page: 757 article-title: The long-term effect of a plaque control program on tooth mortality, caries and periodontal disease in adults. Results after 30 years of maintenance publication-title: J Clin Periodontol contributor: fullname: Lindhe – volume: 84 start-page: 715 year: 2005 end-page: 720 article-title: New coronal caries in older adults: implications for prevention publication-title: J Dent Res contributor: fullname: Zlobin – volume: 45 start-page: 162 year: 2011 end-page: 173 article-title: The effect of chlorhexidine varnish on root caries: a systematic review publication-title: Caries Res contributor: fullname: van der Weijden – volume: 11 start-page: 84 year: 2011 end-page: 86 article-title: Chlorhexidine varnish may prevent dental caries in children and adolescents publication-title: J Evid Based Dent Pract contributor: fullname: Bekhuis – volume: 17 start-page: 67 year: 2000 end-page: 76 article-title: The effectiveness of 10% chlorhexidine varnish treatment on dental caries incidence in adults with dry mouth publication-title: Gerodontology contributor: fullname: Perry – year: 2011 article-title: Examiner training and reliability in two randomized clinical trials of adult dental caries publication-title: J Public Health Dent contributor: fullname: Holland – volume: 25 start-page: 60 year: 1997 end-page: 68 article-title: Proposed methods for improving the efficiency of the DMFS index in assessing initiation and progression of dental caries publication-title: Community Dent Oral Epidemiol contributor: fullname: Selwitz – volume: 7 start-page: 147 year: 2002 end-page: 177 article-title: Missing data: our view of the state of the art publication-title: Psychol Methods contributor: fullname: Graham – start-page: 143 volume-title: Proceedings of the Seventh Indiana Conference year: 2005 ident: bibr5-0022034511424154 contributor: fullname: Biesbrock AR – ident: bibr6-0022034511424154 doi: 10.1177/154405910208100912 – ident: bibr15-0022034511424154 – ident: bibr9-0022034511424154 – ident: bibr19-0022034511424154 doi: 10.1159/000327374 – ident: bibr1-0022034511424154 doi: 10.1111/j.1600-051X.2004.00563.x – ident: bibr4-0022034511424154 doi: 10.1016/j.jebdp.2011.03.004 – ident: bibr11-0022034511424154 doi: 10.1177/154405910508400806 – ident: bibr12-0022034511424154 doi: 10.1177/154405910408301s03 – ident: bibr18-0022034511424154 doi: 10.1037/1082-989X.7.2.147 – ident: bibr14-0022034511424154 doi: 10.1111/j.1600-0528.1997.tb00900.x – ident: bibr16-0022034511424154 doi: 10.1177/00220345880670031401 – ident: bibr17-0022034511424154 doi: 10.1002/9780470316696 – ident: bibr10-0022034511424154 doi: 10.1159/000016619 – ident: bibr20-0022034511424154 doi: 10.1186/1472-6831-10-23 – volume: 20 start-page: 37 year: 1960 ident: bibr7-0022034511424154 publication-title: Psychol Bull contributor: fullname: Cohen J – ident: bibr8-0022034511424154 doi: 10.1111/j.1834-7819.2008.00064.x – ident: bibr13-0022034511424154 doi: 10.1159/000315346 – ident: bibr3-0022034511424154 doi: 10.1111/j.1752-7325.2011.00278.x – ident: bibr2-0022034511424154 doi: 10.1111/j.1741-2358.2000.00067.x |
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| Snippet | The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk... |
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| SubjectTerms | Administration, Topical Adolescent Adult Aged Aged, 80 and over Anti-Infective Agents, Local - administration & dosage Chlorhexidine - administration & dosage Crowns Dental Caries - classification Dental Caries - prevention & control Dental Caries Susceptibility - drug effects Dental Enamel - drug effects Dental Enamel - pathology Dental Restoration, Permanent Dentin - drug effects Dentin - pathology Dentistry Disease Progression DMF Index Double-Blind Method Female Follow-Up Studies Humans Male Middle Aged Placebos Research Reports Root Caries - prevention & control Tooth Loss - classification Tooth Root - drug effects Tooth Root - pathology Treatment Outcome Young Adult |
| Subtitle | A Randomized Trial |
| Title | Efficacy of Chlorhexidine Varnish for the Prevention of Adult Caries |
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