search
Back to results

Resin Infiltration to Arrest Early Tooth Decay

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resin infiltration
Sham treatment
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Preventive therapy

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Saunders USADC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Resin infiltration

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).

Full Information

First Posted
April 20, 2012
Last Updated
January 22, 2019
Sponsor
University of Michigan
Collaborators
DMG Dental Material Gesellschaft mbH
search

1. Study Identification

Unique Protocol Identification Number
NCT01584024
Brief Title
Resin Infiltration to Arrest Early Tooth Decay
Official Title
Radiographic Progression of Early Caries Lesions After Resin Infiltration
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
DMG Dental Material Gesellschaft mbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Preventive therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resin infiltration
Arm Type
Active Comparator
Arm Description
Resin infiltration of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application)
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham treatment of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application)
Intervention Type
Device
Intervention Name(s)
Resin infiltration
Other Intervention Name(s)
ICON Infiltration kit (DMG, Germany) (ICON=product name)
Intervention Description
Baseline treatment of one caries lesion with resin infiltration therapy, in addition to preventative measures and behavioral modification. ICON product: FDA-510(k): K100062
Intervention Type
Device
Intervention Name(s)
Sham treatment
Intervention Description
Baseline treatment of one caries lesion with sham treatment, in addition to preventative measures and behavioral modification.
Primary Outcome Measure Information:
Title
Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions)
Description
Cumulative lesion progression as measured by PW comparison of radiographs (baseline versus 3 year)
Time Frame
3 Years
Secondary Outcome Measure Information:
Title
Number of Lesions With Progression as Measured by Depth Category (N=Lesions)
Description
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).
Time Frame
3 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathilde C Peters, DMD, PhD
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
Saunders USADC
City
West Point
State/Province
New York
ZIP/Postal Code
10996
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31526071
Citation
Peters MC, Hopkins AR Jr, Zhu L, Yu Q. Efficacy of Proximal Resin Infiltration on Caries Inhibition: Results from a 3-Year Randomized Controlled Clinical Trial. J Dent Res. 2019 Dec;98(13):1497-1502. doi: 10.1177/0022034519876853. Epub 2019 Sep 16.
Results Reference
derived

Learn more about this trial

Resin Infiltration to Arrest Early Tooth Decay

We'll reach out to this number within 24 hrs