Resin Infiltration to Arrest Early Tooth Decay

Dental Caries Clinical Trial

Official title:

Radiographic Progression of Early Caries Lesions After Resin Infiltration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01584024
• Other study ID #: N010508-S3
• Secondary ID: 12-PAF02598
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• Resin infiltration
Baseline treatment of one caries lesion with resin infiltration therapy, in addition to preventative measures and behavioral modification. ICON product: FDA-510(k): K100062
• Sham treatment
Baseline treatment of one caries lesion with sham treatment, in addition to preventative measures and behavioral modification.

Locations

Country	Name	City	State
United States	Saunders USADC	West Point	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	DMG Dental Material Gesellschaft mbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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