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

This study has been completed.
Sponsor:
Collaborator:
DMG Dental Material Gesellschaft mbH
Information provided by (Responsible Party):
Mathilde Peters, DMD, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01496456
First received: December 9, 2011
Last updated: July 12, 2016
Last verified: July 2016
  Purpose
This study is investigating the efficacy of caries lesion infiltration therapy as compared to the current preventative approach for early caries lesions.

Condition Intervention Phase
Dental Caries
Device: Resin infiltration
Behavioral: Caries management
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radiographic Progression of Infiltrated Caries Lesions In-vivo

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous) [ Time Frame: Baseline through 3 years ] [ Designated as safety issue: No ]
    Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).


Secondary Outcome Measures:
  • Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories [ Time Frame: Baseline through 3 years ] [ Designated as safety issue: No ]
    Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA).

  • Lesion Survival After 3 Years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Discrete time survival analysis of time to first lesion progression.


Enrollment: 17
Study Start Date: May 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   14 Years to 35 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: December 9, 2011
Results First Received: February 17, 2016
Last Updated: July 12, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by 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

ClinicalTrials.gov processed this record on August 25, 2016