N/A N=42 Randomized Double-blind Treatment

Resin Infiltration to Arrest Early Tooth Decay

Dental Caries

Bottom Line

View on ClinicalTrials.gov: NCT01584024 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions) — 4; 14 Lesions — p==0.003

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Resin infiltration (Device); Sham treatment (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions)	4; 14	=0.003 sig
SECONDARY Number of Lesions With Progression as Measured by Depth Category (N=Lesions)	3; 7	=0.17

Summary

The purpose of this study is to determine whether lesion infiltration is an effective management strategy to arrest early tooth decay.

Eligibility Criteria

Inclusion Criteria

DMFT ≥ 3 (DMFT = index of decayed-missing-filled permanent teeth)
Having at least two early caries lesions in approximal posterior tooth surfaces
Lesions 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 (NCT01584024). 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.