CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 983 enrolled
Drug / intervention
10% w/v chlorhexidine acetate coating FDA IND #45466 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00357877
NCT00357877Phase 3Completed
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Prevention of Adult Caries Study

Tufts University·interventional·Posted Jul 28, 2006·Updated Jun 14, 2017

In Brief

A Phase 3 clinical trial evaluating 10% w/v chlorhexidine acetate coating FDA IND #45466 and Placebo for Caries, Dental. Completed, enrolled 983 participants across 4 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCaries, Dental
CountriesUnited States
CollaboratorsNational Institute of Dental and Craniofacial Research (NIDCR)

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 28, 2006
Enrollment StartJul 1, 2006
Primary CompletionAug 1, 2009
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 19.9 years ago

Interventions

10% w/v chlorhexidine acetate coating FDA IND #45466drug

Dental coating topically applied by dental professional supragingivally to the full dentition

Placeboother