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Trial record 40 of 1200 for:    tooth decay

Resin Infiltration to Arrest Early Tooth Decay

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ClinicalTrials.gov Identifier: NCT01584024
Recruitment Status : Completed
First Posted : April 24, 2012
Results First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
DMG Dental Material Gesellschaft mbH
Information provided by (Responsible Party):
Mathilde Peters, DMD, PhD, University of Michigan

Brief Summary:
The purpose of this study is to determine whether lesion infiltration is an effective management strategy to arrest early tooth decay.

Condition or disease Intervention/treatment Phase
Dental Caries Device: Resin infiltration Device: Sham treatment Not Applicable

Detailed Description:
A 3-year prospective, randomized control clinical trial (RCT) is designed incorporating a split mouth intra-oral design. Young volunteers (18-24 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 resin infiltration therapy as adjunct to standard-of-care preventative measures. Lesion status (non-cavitated) is clinically confirmed prior to implementing the assigned therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radiographic Progression of Early Caries Lesions After Resin Infiltration
Study Start Date : March 2013
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Active Comparator: Resin infiltration
Resin infiltration of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application)
Device: Resin infiltration

Baseline treatment of one caries lesion with resin infiltration therapy, in addition to preventative measures and behavioral modification.

ICON product: FDA-510(k): K100062

Other Name: ICON Infiltration kit (DMG, Germany) (ICON=product name)

Sham Comparator: Control
Sham treatment of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application)
Device: Sham treatment
Baseline treatment of one caries lesion with sham treatment, in addition to preventative measures and behavioral modification.




Primary Outcome Measures :
  1. Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions) [ Time Frame: 3 Years ]
    Cumulative lesion progression as measured by PW comparison of radiographs (baseline versus 3 year)


Secondary Outcome Measures :
  1. Number of Lesions With Progression as Measured by Depth Category (N=Lesions) [ Time Frame: 3 Years ]
    Radiographic lesion depth categories: E2 (inner enamel), D1 (outer dentin) and D2-rest (middle dentin or restored). Lesion depth assessment on single radiograph (baseline, 3 yr).



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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DMFT ≥ 3 (DMFT = index of decayed-missing-filled permanent teeth)
  • Having at least two early caries lesions in approximal posterior tooth surfaces
  • Lesions visible on radiograph

Exclusion Criteria:

  • Current participation in another clinical study
  • Medically compromised subjects
  • Hyposalivation
  • Pregnancy
  • Allergic to methylmethacrylates
  • Allergic to latex
  • Symptomatic teeth

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584024


Locations
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United States, New York
Saunders USADC
West Point, New York, United States, 10996
Sponsors and Collaborators
University of Michigan
DMG Dental Material Gesellschaft mbH
Investigators
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Study Chair: Mathilde C Peters, DMD, PhD University of Michigan
  Study Documents (Full-Text)

Documents provided by Mathilde Peters, DMD, PhD, University of Michigan:

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Responsible Party: Mathilde Peters, DMD, PhD, Professor Emerita, University of Michigan
ClinicalTrials.gov Identifier: NCT01584024     History of Changes
Other Study ID Numbers: N010508-S3
12-PAF02598 ( Other Identifier: U-Michigan )
First Posted: April 24, 2012    Key Record Dates
Results First Posted: February 12, 2019
Last Update Posted: February 12, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mathilde Peters, DMD, PhD, University of Michigan:
Dental caries
Proximal surfaces
Posterior teeth
Carious lesions
Tooth diseases
Preventive therapy

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases