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NCT00357877 · ClinicalTrials.gov registry record · Phase 3
Prevention of Adult Caries Study (PACS)
A Phase 3 study, sponsored by Tufts University.
- Completed
- Registry status
- Phase 3
- Development phase
- 983
- Enrollment target
NCT00357877: Completed Phase 3 study, sponsored by Tufts University.
NCT00357877 is a Phase 3 study that has completed, run by Tufts University. The registered enrollment target is 983 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00357877, a Phase 3 study, has completed, sponsored by Tufts University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 983 participants
- Enrollment target
Study 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.
Primary Outcome
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,
Interventions
- OTHER Placebo
- DRUG 10% w/v chlorhexidine acetate coating FDA IND #45466
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 983 participants |
| Start Date | 2006-07 |
| Est. Completion | 2010-06 |
| Phase | Phase 3 |
What the finished NCT00357877 record still lists
NCT00357877 is an interventional study that assigns participants to a tested intervention. The registered 983 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00357877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00357877 about?
NCT00357877 is a clinical study titled "Prevention of Adult Caries Study (PACS)". 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 ...
What is the current status of trial NCT00357877?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 983 participants. The study started on 2006-07. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00357877?
The interventions under investigation include: Placebo (OTHER), 10% w/v chlorhexidine acetate coating FDA IND #45466 (DRUG).
Who is sponsoring clinical trial NCT00357877?
This trial is sponsored by Tufts University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00357877's enrollment target sits among peer trials
983 322nd of 2000 higher than 1,679 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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