Radiographic Progression of Infiltrated Caries Lesions In-vivo (ICON)

University of Michigan

Status: Completed

Conditions: Dental Caries

Treatments: Behavioral: Caries management; Device: Resin infiltration

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01496456

10-PAF03721 (Other Identifier)

PG#N010508

Details and patient eligibility

About

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

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 14 to 35 years old

Volunteers: No Healthy Volunteers

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

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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17 participants in 2 patient groups, including a placebo group

Preventative measures

Placebo Comparator group

Description:

Caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation

Treatment:

Behavioral: Caries management

Lesion infiltration

Active Comparator group

Description:

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

Treatment:

Device: Resin infiltration

Behavioral: Caries management