Efficacy of Proximal Caries Infiltration

This study is currently recruiting participants.
Verified November 2012 by DMG Dental Material Gesellschaft mbH
Sponsor:
Collaborators:
UNIVERSIDADE FEDERAL DO RIO DE JANEIRO (FACULDADE DE ODONTOLOGIA)
Brazilian agency (FAPERJ); grant: FAPERJ-APQ1 E-26/110.273/2012
Information provided by (Responsible Party):
DMG Dental Material Gesellschaft mbH
ClinicalTrials.gov Identifier:
NCT01726179
First received: November 1, 2012
Last updated: September 5, 2013
Last verified: November 2012
  Purpose

the goal of the project is to investigate the clinical efficacy of management of early caries lesions by resin infiltration and to further scrutinize the patient stress experiences.


Condition Intervention
Dental Health
Caries
Device: Icon infiltration
Device: control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by DMG Dental Material Gesellschaft mbH:

Primary Outcome Measures:
  • caries progression after infiltration [ Time Frame: 1 yr, 2 yrs, 3 yrs ] [ Designated as safety issue: No ]
    To test the efficacy of caries infiltration with a low viscosity resin (Infiltrant; DMG, Hamburg, Germany) in controlling the progression of non-cavitated proximal lesions in primary molars in comparison to conventional non invasive treatment (daily plaque control brushing with fluoride dentifrice and flossing).


Secondary Outcome Measures:
  • stress reaction during treatment [ Time Frame: baseline ] [ Designated as safety issue: No ]
    To evaluate dental anxiety and stress reactions in relation to the caries infiltration procedure in comparison with a dental examination appointment and conventional resin restoration appointment.


Estimated Enrollment: 66
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Icon infiltration
Icon infiltration regarding instructions for use
Device: Icon infiltration

Patients and their guardians will be instructed to use dental floss to remove dental biofilm in both proximal sites once a day and to brush teeth with fluorated toothpaste twice a day. Besides that, test lesion will be infiltrated with a low viscosity resin (Icon, DMG, Hamburg, Germany). The test lesions will be treated using Icon (DMG, Hamburg, Germany) following the instruction for use.

A sub-sample with children with indication for a composite restoration in at least one proximal surface will be selected for the analysis of dental anxiety and stress.

Active Comparator: control
conventional non invasive treatment
Device: control

Patients and their guardians will be instructed to use dental floss to remove dental biofilm in both proximal sites once a day and to brush teeth with fluoridated toothpaste twice a day.

A sub-sample with children with indication for a composite restoration in at least one proximal surface will be selected for the analysis of dental anxiety and stress.


Detailed Description:

The aim of this study is to test the clinical efficacy of caries infiltration to arrest proximal caries lesions in primary molars. It was hypothesized that infiltrated lesions (test lesions) will progress significantly less than non infiltrated lesions (control lesions). Additionally, it was hypothesized that dental anxiety and stress related to caries infiltration will be significantly less than dental anxiety related to a conventional restorative procedure. The study will be a controlled clinical trial with a split mouth design and blind evaluation of the outcome (caries progression). Caries progression will be evaluated annually, 12, 24, and 36 months after treatment.

  Eligibility

Ages Eligible for Study:   5 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with one tooth surface with active caries lesions
  • two primary molars with proximal lesion detected on the x-ray (scores 2 (E2) or 3 (D1) in Mejàre et al. scoring system with less depth
  • asigned informed consent.

Exclusion Criteria:

  • children who do not cooperate during dental appointments
  • primary molars supposed to exfoliate in less than two years
  • lesions showing obvious cavitation or clear sings of inactivity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726179

Contacts
Contact: Vera M Soviero, Prof., Dr. +(21) 25 87 63 72 verasoviero@gmail.com
Contact: Ivete PR de Souza, Prof., Dr. +(21) 25 62 21 01

Locations
Brazil
Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia. Recruiting
Rio de Janeiro, Brazil, 20551-031
Contact: Vera M Soviero, Prof., Dr.    +(21) 25 87 63 72    verasoviero@gmail.com   
Contact: Ivete PR de Souza, Prof., Dr.    +(21) 25 62 21 01      
Principal Investigator: Vera M Soviero, Prof., Dr.         
Sub-Investigator: Ivete PR de Souza, Prof., Dr.         
Sub-Investigator: Michelle Ammari, Dr.         
Sponsors and Collaborators
DMG Dental Material Gesellschaft mbH
UNIVERSIDADE FEDERAL DO RIO DE JANEIRO (FACULDADE DE ODONTOLOGIA)
Brazilian agency (FAPERJ); grant: FAPERJ-APQ1 E-26/110.273/2012
Investigators
Principal Investigator: Vera Mendes Soviero, Prof., Dr. Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia. Boulevard 28 de Setembro, 157 Vila Isabel 20551-031 - Rio de Janeiro, RJ Brasil
  More Information

No publications provided

Responsible Party: DMG Dental Material Gesellschaft mbH
ClinicalTrials.gov Identifier: NCT01726179     History of Changes
Other Study ID Numbers: ECIPRJ13
Study First Received: November 1, 2012
Last Updated: September 5, 2013
Health Authority: Brazil: Comissão Nacional de Ética em Pesquisa (Conep)

Keywords provided by DMG Dental Material Gesellschaft mbH:
caries infiltration
caries arrest
dental anxiety
dental stress

ClinicalTrials.gov processed this record on April 15, 2014