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

December 9, 2011
July 12, 2016
May 2010
July 2014   (final data collection date for primary outcome measure)
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).
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
Complete list of historical versions of study NCT01496456 on ClinicalTrials.gov Archive Site
  • 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.
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 over-the-counter fluoride supplements
    Other Name: Home use of over-the-counter 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 of oral hygiene instruction, diet counseling and fluoride supplementation
    Interventions:
    • Device: Resin infiltration
    • Behavioral: Caries management
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
14 Years to 35 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01496456
PG#N010508, 10-PAF03721
No
No
Not Provided
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
July 2016

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