NCT00357877|CompletedPhase 3ResultsDMC
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Sponsor study identifier
Secondary identifiers
NIH
interventional
983
1 country
4
Study Start
July 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2009
Actual (reported)Study Completion
June 2010
Actual (reported)Adult tooth decay is an infectious disease that afflicts the majority of Americans aged 55 and older and is the most common chronic disease at midlife with an ever growing economic toll. Despite the fact that specific bacteria cause tooth decay, no FDA-approved anti-microbial treatment for decay is available to the American dental professional. The Prevention of Adult Caries Study (PACS) is a study designed to evaluate the efficacy of a topical, temporary, 10% w/v chlorhexidine dental coating in reducing new decay in adult dental patients at risk for decay.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2006
Date type not reportedThis date has not been verified as actual or estimated.
July 26, 2006
Actual (reported)July 28, 2006
Actual (reported)August 2009
Actual (reported)June 2010
Actual (reported)June 14, 2017
Actual (reported)Total Net D12FS Caries Increment (Total of Non-cavitated Lesions (D1), Cavitated Lesions (D2) and Sound Surfaces (S))
Study duration was too short to have progression from D2 (cavitated lesions) to D3 (cavitated lesions that involved dentin). D2 and D3 were treated equivalently for analysis. This measure is computed as the sum of weighted counts of transitions in tooth surface status (root and coronal surfaces combined) from randomization to the 13-month follow-up visit. Disease progression had a positive weight (e.g., S-to-D1 (sound to non-cavitated lesion) or D1-to-D2 (non-cavitated to cavitated lesion) = 1, S-to-D2 (sound to cavitated lesion)= 2). Reversal had a negative weight (e.g., D1-to-S = -1). No change, transitions to or from missing or unscorable, and impossible transitions had 0 weight. Incident fillings and crowns were treated the same as incident D2 lesions for purposes of scoring. More details of the transition weights may be found at Vollmer WM et al. (2010). Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a
(V1) to the 13 month follow-up visit
Cumulative Net D12FS Caries Increment
Visit 1, 7-month follow-up, 13-month follow-up
Total Crude D12FS Caries Increment
V1-13-month follow-up
Cumulative Crude D12FS Caries Increment
Visit 1, 7-month follow-up, 13-month follow-up
Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
10% w/v chlorhexidine acetate coating FDA IND #45466. Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition
Dental coating topically applied by dental professional supragingivally to the full dentition
Tuba City Regional Health Care
Tuba City, Arizona, 86045-0600, United States
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111, United States
Dental Services of Massachusetts
Boston, Massachusetts, 02129, United States
Center for Health Research
Portland, Oregon, 97227, United States
Papas AS, Vollmer WM, Gullion CM, Bader J, Laws R, Fellows J, Hollis JF, Maupome G, Singh ML, Snyder J, Blanchard P; PACS Collaborative Group. Efficacy of chlorhexidine varnish for the prevention of adult caries: a randomized trial. J Dent Res. 2012 Feb;91(2):150-5. doi: 10.1177/0022034511424154. Epub 2011 Dec 7.
Singh M, Papas A, Vollmer W, Bader J, Laws R, Maupome G, Snyder J, Blanchard P. Predictors of coronal caries progression in adults: results from the Prevention of Adult Caries Study. Community Dent Oral Epidemiol. 2013 Dec;41(6):558-64. doi: 10.1111/cdoe.12059. Epub 2013 Jul 9.
Athena Papas, PhD DMD
Tufts University of Dental Medicine
983 participants (actual enrollment reported by the registry).
First Submitted
July 26, 2006
First Posted
July 28, 2006
Study Start
July 2006
Date type not reportedThis date has not been verified as actual or estimated.
Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Banting DW, Amaechi BT, Bader JD, Blanchard P, Gilbert GH, Gullion CM, Holland JC, Makhija SK, Papas A, Ritter AV, Singh ML, Vollmer WM. Examiner training and reliability in two randomized clinical trials of adult dental caries. J Public Health Dent. 2011 Fall;71(4):335-44. doi: 10.1111/j.1752-7325.2011.00278.x. Epub 2011 Aug 17.
Vollmer WM, Papas AS, Bader JD, Maupome G, Gullion CM, Hollis JF, Snyder JJ, Fellows JL, Laws RL, White BA; PACS Collaborative Research Group. 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. BMC Oral Health. 2010 Oct 5;10:23. doi: 10.1186/1472-6831-10-23.
Primary Completion
August 2009
Actual (reported)Study Completion
June 2010
Actual (reported)Last Updated
June 14, 2017
Results First Posted
June 14, 2017
Record last verified: 2017-05
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Source: ClinicalTrials.gov.
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