Overview

This trial is active, not recruiting.

Conditions dental health, caries
Treatments icon infiltration, control
Sponsor DMG Dental Material Gesellschaft mbH
Collaborator Universidade Federal do Rio de Janeiro
Start date December 2012
End date December 2016
Trial size 66 participants
Trial identifier NCT01726179, ECIPRJ13

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
Icon infiltration regarding instructions for use
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)
conventional non invasive treatment
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.

Primary Outcomes

Measure
caries progression after infiltration
time frame: 1 yr, 2 yrs, 3 yrs

Secondary Outcomes

Measure
stress reaction during treatment
time frame: baseline

Eligibility Criteria

Male or female participants from 5 years up to 7 years old.

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

Additional Information

Official title Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial
Principal investigator Vera Mendes Soviero, Prof., Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by DMG Dental Material Gesellschaft mbH.