At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 33 enrolled
Drug / intervention
C16G2 Varnish +1 moredrug
Likely dose
C16G2 Varnish dose not specified in provided informationAI-extracted
Key inclusion· 6
- ✓Ages 12-75 years
- ✓Minimum 12 bicuspids and molars total, with at least 8 molars and bicuspids without restorations, crowns, or sealants
- ✓Salivary S. mutans of 1.0 x 10^5 CFUs/mL or greater at Screening
- ✓Able to expectorate ≥2 mL of stimulated saliva in 5 minutes
Key exclusion· 8
- ✕Advanced periodontal disease
- ✕Active caries lesion(s) within 30 days prior to study drug administration (insipient, non-cavitated lesions are allowed)
- ✕Partially erupted teeth where entire crown is not erupted or operculum is present
- ✕Full dentures or permanent orthodontic appliances (braces)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Single-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Microbiology of C16G2 Varnish Administered in Multiple Doses to Adolescent and Adult Dental Subjects
In Brief
A Phase 2 clinical trial evaluating C16G2 Varnish and Placebo Varnish for Dental Caries. Completed, enrolled 33 participants across 3 sites.
Detailed Summary
The purpose of this single-blind study is to evaluate whether C16G2 Varnish administered in multiple doses can effectively kill the bacteria in the oral cavity that cause dental caries.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartJan 2017
Primary CompletionMar 2017
TodayJul 2026
First PostedDec 28, 2016
Enrollment StartJan 27, 2017
Primary CompletionMar 29, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.5 years ago
Interventions
C16G2 Varnishdrug
Antimicrobial Peptide
Placebo Varnishdrug
Placebo