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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

December 9, 2011
November 13, 2013
May 2010
May 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01496456 on ClinicalTrials.gov Archive Site
  • 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
Radiographic lesion size [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Radiographic lesion size as determined visually (single and pair-wise comparison)
Not Provided
Not Provided
 
Radiographic Progression of Infiltrated Caries Lesions In-vivo
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Dental Caries
  • 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
  • Placebo Comparator: Preventative measures
    Caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation
    Intervention: Behavioral: Caries management
  • Active Comparator: Lesion infiltration
    Resin infiltration of caries lesion in addition to caries management by preventative measures
    Interventions:
    • Device: Resin infiltration
    • Behavioral: Caries management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
16
June 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
14 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01496456
PG#N010508, 10-PAF03721
No
Mathilde Peters, DMD, PhD, University of Michigan
University of Michigan
DMG Dental Material Gesellschaft mbH
Study Chair: Mathilde C Peters, DMD, PhD University of Michigan
University of Michigan
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP