Radiographic Progression of Infiltrated Caries Lesions In-vivo

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Device: Resin infiltration; Behavioral: Caries management

• Registration Number: NCT01496456
• Lead Sponsor: University of Michigan

Brief Summary

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

Detailed Description

A 3-year longitudinal, prospective, randomized control clinical trial (RCT) is designed incorporating a split-mouth intra-oral design. Young volunteers (14-35 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 infiltrating the lesions. The infiltration protocol included application of on-market materials and applicators, and was performed in one session.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-12-09
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-21
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2016-02-17
• Results First Submitted QC: 2016-07-12
• Results First Posted: 2016-07-14
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-09
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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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
Lesion infiltration	Resin infiltration	Resin infiltration of caries lesion in addition to caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation
Lesion infiltration	Caries management	Resin infiltration of caries lesion in addition to caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation
Preventative measures	Caries management	Caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation

Primary Outcome Measures

Name	Time	Method
Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)	Baseline through 3 years	Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).

Secondary Outcome Measures

Name	Time	Method
Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories	Baseline through 3 years	Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA).
Lesion Survival After 3 Years	3 years	Discrete time survival analysis of time to first lesion progression.

Trial Locations

Locations (1)

University of Toledo Medical Center; 🇺🇸 Toledo, Ohio, United States