N/A Completed N=17 Randomized Double-blind Treatment

Radiographic Progression of Infiltrated Caries Lesions In-vivo

Source: ClinicalTrials.gov NCT01496456 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2016

Primary outcomePrimary: Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous) — 2; 11 Lesions — p=0.002

Summary

This study is investigating the efficacy of caries lesion infiltration therapy as compared to the current preventative approach for early caries lesions.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.