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Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth

NCT04195386 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2019-12-11

No results posted yet for this study

Summary

Atypical cavities, which involve more than two surfaces being one of them vestibular or lingual/palatine, are a challenge for restorative dentistry, since the risk of failure of the restorations are related to the number of surfaces involved. Thus, the objective of this project is to conduct a randomized clinical trial in order to evaluate the efficacy and patient-centered outcomes of a chemically-activated alkasite composite resin in atypical lesions of deciduous molars. Deciduous molars of children between 4 and 7 years of age with at least one atypical cavity lesion in deciduous molars will be selected for the ECR. The selected teeth will be randomly divided into two groups: Chemically activated composite resin Alkasite and resin-Modified glass ionomer cement. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The efficacy of the treatments will be evaluated by the longevity of the restoring procedures and the arrestment of the caries lesions. Patient-centered outcomes will also be evaluated.

Conditions

  • Dental Caries in Children

Interventions

PROCEDURE

Dental Restoration with Chemically activated Composite resin Alkasite

Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with chemically activated composite resin Alkasite.

PROCEDURE

Dental Restoration with Resin-Modified Glass ionomer Cement

Selective removal of dental caries with manual instruments, under relative isolation, application of polyacrylic acid and restoration with resin-modified glass ionomer cement.

Sponsors & Collaborators

  • Faculty Sao Leopoldo Mandic Campinas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-01-30
Completion
2021-01-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04195386 on ClinicalTrials.gov