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 2012-02, Vol.91 (2), p.150-155
Main Authors: Papas, A.S., Vollmer, W.M., Gullion, C.M., Bader, J., Laws, R., Fellows, J., Hollis, J.F., Maupomé, G., Singh, M.L., Snyder, J., Blanchard, P., White, Alex, Blanchard, Peter, Deane, Joy-Ann, Hamburger, Keith, Johnson, Joanne, Johnson, Kristen, Marangi-Marsden, Rosemary, Molina, Nydia, O’Connor, Kimberly, Tavano, Joanne, Torresyap, Gay, Maupome, Gerardo, Begay, Marilyn, Goldtooth, Tracy, Haskie, Jacqueline, Honanie, Eric, Masaquaptewa, Adrinne, Oh, Junhie, Peaches, Rantreva, Phipps, Kathy, Robertson, L.D., Ryczek, Shelli, Talayumptewa, Corina, Papas, Athena, Arkema, Elizabeth, Brown, Ashley, Burns, Virginia, Casey, Moira, Corrado, Pamela, Douglas, Mark, Ganda, Kachan, Gulati, Harish, Harrington, Dorothy, Krizova, Lucie, Lee, Karen, O’Connor, Julie, Ragone, Lauren, Russell, David, Singh, Medha, Singh, Mabi, Soter, John Cleeve, Stevens, George, Sundaralingam, Shankeertha, Tzavaras, Elizabeth, Snyder, John, Bernel, Diane, Brittan, John, Brooks, Leah, Carlston, Jennifer, Cheek, Paul, Clark, Donna, Downing, Joyce, Farrell, Kelsie, Gleason, Donna, Hankins, Janet, Hollis, Jack, Johnson, Cheryl, LaFerriere, Dan, Little, Sally Jo, Massinger, Lisa, Muessig, Kristin, Olson, Ora Lee, Richards, Kim, Snyder, Craig, Strong, Barbara, Vollmer, William M., Bader, James, Bardsley, Jeanette, Booker, Kristina, Chen, Chuhe, Chen, Ping, Dixon, Arthor, Donald, Judy, Elder, Charles, Fellows, Jeffrey, Funkhouser, Kimberly, Giullion, Christina, Kirk, Kelly, Laws, Reesa, Machen, Celeste, Meltesen, Gayle, Rasathurai, Sumithran, Reck, Deborah
Format: Article
Language:English
Subjects:
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
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Summary: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).
ISSN:0022-0345
1544-0591
DOI:10.1177/0022034511424154