Phase 3
N=983
Prevention of Adult Caries Study (PACS)
Caries, Dental
Bottom Line
View on ClinicalTrials.gov: NCT00357877 ↗Enrolled (actual)
983
Serious AEs
6.0%
Results posted
Jun 2017
Primary outcome: Primary: Total Net D12FS Caries Increment (Total of Non-cavitated Lesions (D1), Cavitated Lesions (D2) and Sound Surfaces (S)) — 2.43; 2.68 weighted increment units/13 months — p=0.56
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 10% w/v chlorhexidine acetate coating FDA IND #45466 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tufts University
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Net D12FS Caries Increment (Total of Non-cavitated Lesions (D1), Cavitated Lesions (D2) and Sound Surfaces (S)) |
2.43; 2.68 | 0.56 |
| SECONDARY Cumulative Net D12FS Caries Increment |
5.53; 5.88 | 0.54 |
| SECONDARY Total Crude D12FS Caries Increment |
6.47; 5.96 | 0.18 |
| SECONDARY Cumulative Crude D12FS Caries Increment |
11.39; 10.72 | 0.24 |
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.
Eligibility Criteria
Inclusion Criteria
- 18 years of age and older
- at least 20 intact natural teeth, excluding third molars
- 2 or more lesions, of which at least one must be a cavitated D2 or D3
- willing and able to provide informed consent
Exclusion Criteria
- pregnant or planning to become pregnant or planning to become pregnant during the study (breastfeeding is permitted)
- use of fixed orthodontic appliances
- allergic to any of the ingredients of the study medication
- long-term antibiotic therapy
- a history of, or currently active, radiation therapy for cancers of the head or neck
- Sjögren's syndrome
- advanced periodontitis
- consumption of the equivalent of more than five servings of acidic or sugared drinks per day
- having 10 or more lesions requiring restorative care at the time of the screening visit
- remineralization therapy within one month of randomization
- investigator discretion
Data sourced from ClinicalTrials.gov (NCT00357877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.