We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01496456
First Posted: December 21, 2011
Last Update Posted: August 8, 2017
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.
Collaborator:
DMG Dental Material Gesellschaft mbH
Information provided by (Responsible Party):
Mathilde Peters, DMD, PhD, University of Michigan
December 9, 2011
December 21, 2011
February 17, 2016
July 14, 2016
August 8, 2017
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 ]
Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).
Annual radiographic lesion progression [ Time Frame: 3 years ]
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 ]
    Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA).
  • Lesion Survival After 3 Years [ Time Frame: 3 years ]
    Discrete time survival analysis of time to first lesion progression.
Radiographic lesion size [ Time Frame: 3 years ]
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
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Sexes Eligible for Study: All
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 ( Other Identifier: U-Michigan )
No
Not Provided
Plan to Share IPD: 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
July 2017

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