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Cost-efficacy of Sealing Moderate Caries Lesions in Occlusal Surfaces of Primary Molars

NCT03005405 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2018-03-22

No results posted yet for this study

Summary

This protocol aims to assess the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. Initially, a non-inferiority study was designed in order to verify if sealing could be non-inferior than restoration. In this case, it could be preferable since it is less invasive. Therefore, cost will be put forward into the analysis considering even reintervention during the follow-ups (cost-efficacy analyses). Finally, the acceptability could be another differential point between treatments.

Conditions

  • Dental Caries

Interventions

PROCEDURE

Ionomer Restoration (control)

Restoration of moderate caries lesions after partial caries removal using high viscosity glass ionomer cements

PROCEDURE

Ionomer Sealant (test)

Sealing of moderate caries lesions without any caries removal or cavity opening.

PROCEDURE

Oral hygiene orientation and professional fluoride application

Oral hygiene orientation and professional fluoride application

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Mariana M Braga, PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2018-12-31
Completion
2018-12-31

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 NCT03005405 on ClinicalTrials.gov