Efficacy of chlorhexidine varnish for the prevention of adult caries: a randomized trial
A S Papas, W M Vollmer, C M Gullion, J Bader, R Laws, J Fellows, J F Hollis, G Maupomé, M L Singh, J Snyder, P Blanchard, PACS Collaborative Group, Alex White, Peter Blanchard, Joy-Ann Deane, Keith Hamburger, Joanne Johnson, Kristen Johnson, Rosemary Marangi-Marsden, Nydia Molina, Kimberly O'Connor, Joanne Tavano, Gay Torresyap, Gerardo Maupome, Marilyn Begay, Tracy Goldtooth, Jacqueline Haskie, Eric Honanie, Adrinne Masaquaptewa, Junhie Oh, Rantreva Peaches, Kathy Phipps, L D Robertson, Shelli Ryczek, Corina Talayumptewa, Athena Papas, Elizabeth Arkema, Ashley Brown, Virginia Burns, Moira Casey, Pamela Corrado, Mark Douglas, Kachan Ganda, Harish Gulati, Dorothy Harrington, Lucie Krizova, Karen Lee, Julie O'Connor, Lauren Ragone, David Russell, Medha Singh, Mabi Singh, John Cleeve Soter, George Stevens, Shankeertha Sundaralingam, Elizabeth Tzavaras, John Snyder, Diane Bernel, John Brittan, Leah Brooks, Jennifer Carlston, Paul Cheek, Donna Clark, Joyce Downing, Kelsie Farrell, Donna Gleason, Janet Hankins, Jack Hollis, Cheryl Johnson, Dan Laferriere, Sally Jo Little, Lisa Massinger, Kristin Muessig, Ora Lee Olson, Kim Richards, Craig Snyder, Barbara Strong, William M Vollmer, James Bader, Jeanette Bardsley, Kristina Booker, Chuhe Chen, Ping Chen, Arthor Dixon, Judy Donald, Charles Elder, Jeffrey Fellows, Kimberly Funkhouser, Christina Giullion, Kelly Kirk, Reesa Laws, Celeste Machen, Gayle Meltesen, Sumithran Rasathurai, Deborah Reck, A S Papas, W M Vollmer, C M Gullion, J Bader, R Laws, J Fellows, J F Hollis, G Maupomé, M L Singh, J Snyder, P Blanchard, PACS Collaborative Group, Alex White, Peter Blanchard, Joy-Ann Deane, Keith Hamburger, Joanne Johnson, Kristen Johnson, Rosemary Marangi-Marsden, Nydia Molina, Kimberly O'Connor, Joanne Tavano, Gay Torresyap, Gerardo Maupome, Marilyn Begay, Tracy Goldtooth, Jacqueline Haskie, Eric Honanie, Adrinne Masaquaptewa, Junhie Oh, Rantreva Peaches, Kathy Phipps, L D Robertson, Shelli Ryczek, Corina Talayumptewa, Athena Papas, Elizabeth Arkema, Ashley Brown, Virginia Burns, Moira Casey, Pamela Corrado, Mark Douglas, Kachan Ganda, Harish Gulati, Dorothy Harrington, Lucie Krizova, Karen Lee, Julie O'Connor, Lauren Ragone, David Russell, Medha Singh, Mabi Singh, John Cleeve Soter, George Stevens, Shankeertha Sundaralingam, Elizabeth Tzavaras, John Snyder, Diane Bernel, John Brittan, Leah Brooks, Jennifer Carlston, Paul Cheek, Donna Clark, Joyce Downing, Kelsie Farrell, Donna Gleason, Janet Hankins, Jack Hollis, Cheryl Johnson, Dan Laferriere, Sally Jo Little, Lisa Massinger, Kristin Muessig, Ora Lee Olson, Kim Richards, Craig Snyder, Barbara Strong, William M Vollmer, James Bader, Jeanette Bardsley, Kristina Booker, Chuhe Chen, Ping Chen, Arthor Dixon, Judy Donald, Charles Elder, Jeffrey Fellows, Kimberly Funkhouser, Christina Giullion, Kelly Kirk, Reesa Laws, Celeste Machen, Gayle Meltesen, Sumithran Rasathurai, Deborah Reck
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 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).
Conflict of interest statement
The authors have no conflicts of interest related to this research. Although CHX Technologies was primarily responsible for the design of the study and provided the active and placebo treatments, the company played no part in the statistical analysis, in the drafting of this manuscript, or in the approval of the final wording. The conduct of PACS was approved and overseen by the PACS DSMB and project officer at NIDCR, and the primary and sec-ondary analyses presented here are in accordance with the analysis plan approved by the DSMB and on file at clinicaltrials.gov
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Source: PubMed