Resin Infiltration to Arrest Early Tooth Decay

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

Detailed Description
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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.

Official Title
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Radiographic Progression of Early Caries Lesions After Resin Infiltration

Conditions
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Dental Caries

Intervention / Treatment
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* Device: Resin infiltration
* Device: Sham treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resin infiltration<br>Resin infiltration of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application) | Device: Resin infiltration<br>* Baseline treatment of one caries lesion with resin infiltration therapy, in addition to preventative measures and behavioral modification. ICON product: FDA-510(k): K100062<br>* Other names: ICON Infiltration kit (DMG, Germany) (ICON=product name);|
| Sham Comparator: Control<br>Sham treatment of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application) | Device: Sham treatment<br>* Baseline treatment of one caries lesion with sham treatment, in addition to preventative measures and behavioral modification.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions) | Cumulative lesion progression as measured by PW comparison of radiographs (baseline versus 3 year) | 3 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Lesions With Progression as Measured by Depth Category (N=Lesions) | 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). | 3 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Preventive therapy