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Completed

NCT Number: NCT01584024

Resin Infiltration to Arrest Early Tooth Decay

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

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saunders USADC

West Point, New York, 10996, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resin infiltration

Device

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 treatment

Device

Baseline treatment of one caries lesion with sham treatment, in addition to preventative measures and behavioral modification.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • DMG Dental Material Gesellschaft mbH

Registry information

Official study title

Radiographic Progression of Early Caries Lesions After Resin Infiltration

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 24, 2012
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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