Resin Infiltration to Arrest Early Tooth Decay

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Device: Resin infiltration; Device: Sham treatment

• Registration Number: NCT01584024
• Lead Sponsor: University of Michigan

Brief Summary

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

Detailed Description

A 3-year prospective, randomized control clinical trial (RCT) is designed incorporating a split mouth intra-oral design. Young volunteers (18-24 years old) with at least two early lesions in posterior teeth will be enrolled into this clinical trial to evaluate the clinical effectiveness of arresting lesion progression by resin infiltration therapy as adjunct to standard-of-care preventative measures. Lesion status (non-cavitated) is clinically confirmed prior to implementing the assigned therapy.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-04-20
• Study First Posted: 2012-04-24
• Study Start: 2013-03
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Results First Submitted: 2018-12-22
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-22
• Last Update Submitted: 2019-01-22
• Results First Posted: 2019-02-12
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

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Exclusion Criteria

• Current participation in another clinical study
• Medically compromised subjects
• Hyposalivation
• Pregnancy
• Allergic to methylmethacrylates
• Allergic to latex
• Symptomatic teeth

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resin infiltration	Resin infiltration	Resin infiltration of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application)
Control	Sham treatment	Sham treatment of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application)

Primary Outcome Measures

Name	Time	Method
Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions)	3 Years	Cumulative lesion progression as measured by PW comparison of radiographs (baseline versus 3 year)

Secondary Outcome Measures

Name	Time	Method
Number of Lesions With Progression as Measured by Depth Category (N=Lesions)	3 Years	Radiographic lesion depth categories: E2 (inner enamel), D1 (outer dentin) and D2-rest (middle dentin or restored). Lesion depth assessment on single radiograph (baseline, 3 yr).

Trial Locations

Locations (1)

Saunders USADC; 🇺🇸 West Point, New York, United States