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Radiographic Progression of Infiltrated Caries Lesions In-vivo (ICON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01496456
Recruitment Status : Completed
First Posted : December 21, 2011
Results First Posted : July 14, 2016
Last Update Posted : August 8, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Dental Caries Device: Resin infiltration Behavioral: Caries management

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radiographic Progression of Infiltrated Caries Lesions In-vivo
Study Start Date : May 2010
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Preventative measures
Caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation
Behavioral: Caries management
Split-mouth design (at least two lesions per patient). Baseline preventative caries management: dietary and behavioral modification, and over-the-counter fluoride supplements
Other Name: Home use of over-the-counter oral health products
Active Comparator: Lesion infiltration
Resin infiltration of caries lesion in addition to caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation
Device: Resin infiltration
Split-mouth design (at least two lesions per patient): Treatment of one caries lesion with resin infiltration therapy
Other Name: ICON (DMG, Germany)
Behavioral: Caries management
Split-mouth design (at least two lesions per patient). Baseline preventative caries management: dietary and behavioral modification, and over-the-counter fluoride supplements
Other Name: Home use of over-the-counter oral health products


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496456


Locations
United States, Ohio
University of Toledo Medical Center
Toledo, Ohio, United States, 43614
Sponsors and Collaborators
University of Michigan
DMG Dental Material Gesellschaft mbH
Investigators
Study Chair: Mathilde C Peters, DMD, PhD University of Michigan
More Information

Publications:
Peters MC, Tuzzio F, Nedley M, Davis W, Bayne SC. Resin Infiltration Effects In A Caries-Active Environment. J Dent Res 92(Spec Iss A):377, 2013.
Peters MC, Tuzzio F, Nedley M, Davis W, Bayne SC. Resin Infiltration Effects In A Caries-Active Environment - 2YR Results. J Dent Res 93(Spec Iss A):161, 2014.
Peters MC, Bula A, Nedley M, Davis W, Bayne SC. Efficacy of Resin Infiltration in High Caries-Active Environment -- 3YR Results. J Dent Res 93(Spec Iss B): 1017, 2014.

Responsible Party: Mathilde Peters, DMD, PhD, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01496456     History of Changes
Other Study ID Numbers: PG#N010508
10-PAF03721 ( Other Identifier: U-Michigan )
First Posted: December 21, 2011    Key Record Dates
Results First Posted: July 14, 2016
Last Update Posted: August 8, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mathilde Peters, DMD, PhD, University of Michigan:
Dental caries
Proximal surfaces
Posterior teeth
Carious lesions
Tooth diseases
Preventive therapy

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs