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

This study is ongoing, but not recruiting participants.
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: November 13, 2013
Last verified: November 2013
  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:
  • Annual radiographic lesion progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Pair-wise radiographic lesion progression after 1, 2 and 3 years as determined by subtraction radiography


Secondary Outcome Measures:
  • Radiographic lesion size [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Radiographic lesion size as determined visually after 1, 2 and 3 years

  • Radiographic lesion size [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Change from Baseline in Radiographic Lesion Size as determined visually after 1, 2 and 3 years


Enrollment: 16
Study Start Date: May 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 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 OTC-fluoride supplements
Other Name: Home use of OTC oral health products
Active Comparator: Lesion infiltration
Resin infiltration of caries lesion in addition to caries management by preventative measures
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 OTC-fluoride supplements
Other Name: Home use of OTC 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 14-35 year old subjects
  • 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

No publications provided

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
Last Updated: November 13, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 01, 2014