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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
BACKGROUND: Dental caries is one of the primary causes of tooth loss among adults. It is estimated to affect a majority of Americans aged 55 and older, with a disproportionately higher burden in disadvantaged populations. Although a number of treatments are currently in use for caries prevention in...
Autores principales: | , , , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
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BioMed Central
2010
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2976725/ https://www.ncbi.nlm.nih.gov/pubmed/20923557 http://dx.doi.org/10.1186/1472-6831-10-23 |
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author | Vollmer, William M Papas, Athena S Bader, James D Maupomé, Gerardo Gullion, Christina M Hollis, Jack F Snyder, John J Fellows, Jeffrey L Laws, Reesa L White, B Alexander |
author_facet | Vollmer, William M Papas, Athena S Bader, James D Maupomé, Gerardo Gullion, Christina M Hollis, Jack F Snyder, John J Fellows, Jeffrey L Laws, Reesa L White, B Alexander |
author_sort | Vollmer, William M |
collection | PubMed |
description | BACKGROUND: Dental caries is one of the primary causes of tooth loss among adults. It is estimated to affect a majority of Americans aged 55 and older, with a disproportionately higher burden in disadvantaged populations. Although a number of treatments are currently in use for caries prevention in adults, evidence for their efficacy and effectiveness is limited. METHODS/DESIGN: The Prevention of Adult Caries Study (PACS) is a multicenter, placebo-controlled, double-blind, randomized clinical trial of the efficacy of a chlorhexidine (10% w/v) dental coating in preventing adult caries. Participants (n = 983) were recruited from four different dental delivery systems serving four diverse communities, including one American Indian population, and were randomized to receive either chlorhexidine or a placebo treatment. The primary outcome is the net caries increment (including non-cavitated lesions) from baseline to 13 months of follow-up. A cost-effectiveness analysis also will be considered. DISCUSSION: This new dental treatment, if efficacious and approved for use by the Food and Drug Administration (FDA), would become a new in-office, anti-microbial agent for the prevention of adult caries in the United States. TRIAL REGISTRATION NUMBER: NCT00357877 |
format | Text |
id | pubmed-2976725 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2010 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-29767252010-11-10 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 Vollmer, William M Papas, Athena S Bader, James D Maupomé, Gerardo Gullion, Christina M Hollis, Jack F Snyder, John J Fellows, Jeffrey L Laws, Reesa L White, B Alexander BMC Oral Health Study Protocol BACKGROUND: Dental caries is one of the primary causes of tooth loss among adults. It is estimated to affect a majority of Americans aged 55 and older, with a disproportionately higher burden in disadvantaged populations. Although a number of treatments are currently in use for caries prevention in adults, evidence for their efficacy and effectiveness is limited. METHODS/DESIGN: The Prevention of Adult Caries Study (PACS) is a multicenter, placebo-controlled, double-blind, randomized clinical trial of the efficacy of a chlorhexidine (10% w/v) dental coating in preventing adult caries. Participants (n = 983) were recruited from four different dental delivery systems serving four diverse communities, including one American Indian population, and were randomized to receive either chlorhexidine or a placebo treatment. The primary outcome is the net caries increment (including non-cavitated lesions) from baseline to 13 months of follow-up. A cost-effectiveness analysis also will be considered. DISCUSSION: This new dental treatment, if efficacious and approved for use by the Food and Drug Administration (FDA), would become a new in-office, anti-microbial agent for the prevention of adult caries in the United States. TRIAL REGISTRATION NUMBER: NCT00357877 BioMed Central 2010-10-05 /pmc/articles/PMC2976725/ /pubmed/20923557 http://dx.doi.org/10.1186/1472-6831-10-23 Text en Copyright ©2010 Vollmer et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Study Protocol Vollmer, William M Papas, Athena S Bader, James D Maupomé, Gerardo Gullion, Christina M Hollis, Jack F Snyder, John J Fellows, Jeffrey L Laws, Reesa L White, B Alexander 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 |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2976725/ https://www.ncbi.nlm.nih.gov/pubmed/20923557 http://dx.doi.org/10.1186/1472-6831-10-23 |
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