Resin Infiltration to Arrest Early Tooth Decay

January 22, 2019 updated by: Mathilde Peters, DMD, PhD, University of Michigan

Radiographic Progression of Early Caries Lesions After Resin Infiltration

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • West Point, New York, United States, 10996
        • Saunders USADC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Resin infiltration
Resin infiltration of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application)
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

Other Names:
  • ICON Infiltration kit (DMG, Germany) (ICON=product name)
Sham Comparator: Control
Sham treatment of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application)
Device: Sham treatment
Baseline treatment of one caries lesion with sham treatment, in addition to preventative measures and behavioral modification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions)
Time Frame: 3 Years
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)
Time Frame: 3 Years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

DMG Dental Material Gesellschaft mbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

April 20, 2012

First Submitted That Met QC Criteria

April 20, 2012

First Posted (Estimate)

April 24, 2012

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N010508-S3
  • 12-PAF02598 (Other Identifier: U-Michigan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Caries

Clinical Trials on Resin infiltration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe