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

NCT04195022 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2019-12-11

No results posted yet for this study

Summary

Atypical cavities, which involve more than two surfaces, one being buccal or lingual/palatal, are a challenge for restorative dentistry, since the risk of restorative failure is related to the number of surfaces involved. Thus, the purpose of this umbrella project is to conduct a randomized controlled trial (RCT) to evaluate the efficacy and patient-centered outcomes of a chemically activated composite alkasite resin in atypical deciduous molar lesions. Primary molars of children aged 4 to 7 years with at least one atypical cavitary lesion in primary molars will be selected for the RCT. The selected teeth will be randomly divided into: Alkasite chemically activated composite resin and Bulk fill composite resin. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The effectiveness of the treatments will be evaluated by the longevity of the restorative procedures and paralysis of the 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 Bulk fill resin composite

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

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
2020-01-30

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 NCT04195022 on ClinicalTrials.gov