Resin Infiltration to Arrest Early Tooth Decay

University of Michigan

Status: Completed

Conditions: Dental Caries

Treatments: Device: Sham treatment; Device: Resin infiltration

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01584024

N010508-S3

12-PAF02598 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Resin infiltration

Active Comparator group

Description:

Resin infiltration of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application)

Treatment:

Device: Resin infiltration

Control

Sham Comparator group

Description:

Sham treatment of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application)

Treatment:

Device: Sham treatment