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)

  Hide Detailed Description

Detailed Description:

Fissure sealing has been shown to inhibit not only the formation of occlusal caries but also to impede the progression of existing caries lesions. Lately, the concept of sealing caries to arrest lesion progression has been transferred to approximal surfaces. In a clinical study sealed approximal lesions showed significantly reduced progression after 18 month compared with those that were treated only with preventive measures.

The pores of enamel caries lesions provide diffusion pathways for acids and dissolved minerals. The aim of caries infiltration is to occlude these pores by infiltration with light curing resins in order to block the diffusion of acids into the lesion body. In contrast to caries sealing, caries infiltration aims to occlude the pores within the lesion rather then placing a diffusion barrier on the lesion surface. Several studies showed significantly reduced progression of infiltrated enamel lesions in demineralizing environments.

This split-mouth placebo-controlled randomized clinical trial was conducted on 16-35 year-old subjects in Bogotá, Colombia (IRB UB.162-2008).

The sample size calculated was of minimum 29 patients with 3 approximal lesions around the EDJ or in the dentin outer third.

The study population was students and patients from Unversidad El Bosque. Two visits were planned for the patients within same week. In the first visit baseline standardized bitewing radiographs were obtained and 3 proximal selected lesions were randomly selected. A clinical examination was conducted to assess DMF-T/S, and individual caries risk. Elastic orthodontic bands were placed between teeth of selected surfaces for elective temporary separation.

In the second visit selected lesions were visually classified with ICDAS criteria and activity status of lesions was assessed. The 3 lesions were randomly allocated to: A. Infiltration, B. Sealing, C. Placebo, and lesions were treated.

Subjects were clinically examined after one, two, and three years by two examiners (AC, JSL) blinded to the selected treatment groups and referral for operative treatment were done if needed. Standardized bitewing radiographs were made each year.

Lesions progression was assessed on radiographs by pair-wise reading by an external examiner blinded to groups. Additionally, after one year reading of images was conducted by digital-subtraction radiography of scanned images. For reproducibility assessment the examiner repeated 20% of radiograph readings by both methods one week after the first reading.

Statistical analysis Intra-examiner reliability for radiographs readings was assessed by unweighted kappa scores; caries experience (DMF-T/S), individual caries risk levels, ICDAS criteria, radiographic scores, and progression' status of selected lesions were reported descriptively.

The outcome variable of changes in lesion progression after 1, 2 and 3 years was assessed by pair-wise radiographic reading and after one year also by digital-subtraction radiography.

Differences in lesion progression between treatments at each follow-up were tested by the Cochran Q test and in case of significant difference between groups, by the McNemar Change test, including the therapeutic effect and the 95% confidence intervals [Siegel & Castellan, 1988].

In all tests p-values less than 0.05 were considered significant.

  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
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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