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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014