Skip to main content
OpenTrials
Completed

NCT Number: NCT01496456

Radiographic Progression of Infiltrated Caries Lesions In-vivo

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

14 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Resin infiltration

Device

Split-mouth design (at least two lesions per patient): Treatment of one caries lesion with resin infiltration therapy

Other names: ICON (DMG, Germany)

Caries management

Behavioral

Split-mouth design (at least two lesions per patient). Baseline preventative caries management: dietary and behavioral modification, and over-the-counter fluoride supplements

Other names: Home use of over-the-counter oral health products

Primary outcomes

  1. Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)

    Time frame: Baseline through 3 years

    Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).

Secondary outcomes

  1. Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories

    Time frame: Baseline through 3 years

    Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA).

  2. Lesion Survival After 3 Years

    Time frame: 3 years

    Discrete time survival analysis of time to first lesion progression.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • DMG Dental Material Gesellschaft mbH

Registry information

Acronym: ICON

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 21, 2011
Registry last updated
Aug 8, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.