Radiographic Progression of Sealed and Infiltrated Caries Lesions in Vivo

This study has been completed.
Sponsor:
Collaborator:
DMG, Germany
Information provided by:
Universidad El Bosque, Bogotá
ClinicalTrials.gov Identifier:
NCT01417832
First received: July 5, 2011
Last updated: August 15, 2011
Last verified: August 2011
  Purpose

The purpose of this study was to compare with a clinical randomized controlled split-mouth design study the changes in the therapeutic effect of infiltrating versus sealing proximal caries lesions and placebo treatment after 1, 2 and 3 years. The outcome was lesion progression, evaluated by radiographic techniques.


Condition Intervention Phase
Dental Caries
Drug: Resin infiltration / adhesive
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radiographic Progression of Sealed and Infiltrated Caries Lesions in Vivo

Resource links provided by NLM:


Further study details as provided by Universidad El Bosque, Bogotá:

Primary Outcome Measures:
  • Pair-wise radiographic lesion progression [ Time Frame: 1, 2, and 3 years ] [ Designated as safety issue: No ]
    Changes in the therapeutic effect of infiltrating versus sealing proximal caries lesions and placebo treatment after 1, 2 and 3 years. The outcome was lesion progression, evaluated by radiographic techniques.


Secondary Outcome Measures:
  • Digital-subtraction radiography lesion progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Changes in the therapeutic effect of infiltrating versus sealing proximal caries lesions and placebo treatment after 1 year. The outcome was lesion progression, evaluated by subtraction radiography.


Enrollment: 37
Study Start Date: January 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment with Infiltrant/Adhesive
In this split-mouth design study, one of the three randomly selected approximal lesions will be treated with an infiltrant resin, one will be treated with an adhesive resin.
Drug: Resin infiltration / adhesive
Treatment at baseline of one caries lesion with a resin infiltration conducted under rubber-dam isolation with the Icon-DMG pre-product; treatment at baseline of another caries lesion with an adhesive under rubber-dam isolation with the Prime Bont NT - Dentsply.
Other Names:
  • Infiltrant: Icon pre-product, DMG
  • Adhesive: Prime Bond NT, Dentsply
Placebo Comparator: Placebo, placebo treatment
In this split-mouth design study, one of the three randomly selected approximal lesions will be treated with a placebo treatment: At baseline one caries lesion was cleaned with a microbrush for 30 seconds and the procedure was repeated after two minutes.
Drug: Placebo
In this split-mouth design study, one of the three randomly selected approximal lesions will be treated with an infiltrant resin, one will be treated with an adhesive resin.
Other Name: Placebo (cleaning of surface)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects were to have at least three caries proximal lesions on their posterior permanent teeth with a radiographic severity classification of the lesion score of 3 -Around the enamel dentin junction (EDJ) or 4 -Dentin-outer 1/3.

Exclusion Criteria:

  • Under orthodontic treatment at enrollment
  • Moving from the city (Bogota) in the following three years after commencing the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417832

Locations
Colombia
Universidad El Bosque
Bogotá, D.c:, Colombia, 11001
Sponsors and Collaborators
Universidad El Bosque, Bogotá
DMG, Germany
Investigators
Study Chair: Stefania Martignon, PhD Universidad El Bosque, Bogotá, COlombia
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universidad El Bosque, Bogotá, Stefania Martignon
ClinicalTrials.gov Identifier: NCT01417832     History of Changes
Other Study ID Numbers: DOC_20080328131018
Study First Received: July 5, 2011
Last Updated: August 15, 2011
Health Authority: Colombia: National Institutes of Health

Keywords provided by Universidad El Bosque, Bogotá:
Dental caries
Proximal surfaces
Preventive therapy
Dental radiography
Treatment efficacy
Young adults

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

ClinicalTrials.gov processed this record on April 17, 2014