N/A
N=17
Radiographic Progression of Infiltrated Caries Lesions In-vivo
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT01496456 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous) — 2; 11 Lesions — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resin infiltration (Device); Caries management (Behavioral)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous) |
2; 11 | 0.002 sig |
| SECONDARY Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories |
2; 9 | 0.045 sig |
| SECONDARY Lesion Survival After 3 Years |
11; 3 | 0.0077 sig |
Summary
This study is investigating the efficacy of caries lesion infiltration therapy as compared to the current preventative approach for early caries lesions.
Eligibility Criteria
Inclusion Criteria
- 14-35 year old subjects
- decayed-missing-filled permanent teeth (DMFT) ≥ 3
- having at least two early caries lesions in approximal posterior tooth surfaces
- lesion visible on radiograph
Exclusion Criteria
- Current participation in another clinical study
- Medically compromised subjects
- Hyposalivation
- Pregnancy
- Allergic to methylmethacrylates
- Allergic to latex
- Symptomatic teeth
Data sourced from ClinicalTrials.gov (NCT01496456). 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.