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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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This study aims to evaluate 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. 96 children aged 3-6 years will be selected. Children must have at least one occlusal surface classified as scores 3 or 4 of International Caries Detection and Assessment System (ICDAS). Children will be randomly allocated according to the treatment: glass ionomer sealant and restoration with glass ionomer. After treatment, teeth will be assessed clinically after 6, 12, 18 and 24 months by trained and blinded examiners regarding the treatment received. The need of reintervention initially treated, either by failures that require repeating of the same procedure or for progression of caries lesions will be considered as primary outcomes. The secondary outcomes will be the chil's acceptability to the treatment.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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restoration - control

Restoration

Group Type ACTIVE_COMPARATOR

Ionomer Restoration (control)

Intervention Type PROCEDURE

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

Oral hygiene orientation and professional fluoride application

Intervention Type PROCEDURE

Oral hygiene orientation and professional fluoride application

sealant - test

Sealant

Group Type EXPERIMENTAL

Ionomer Sealant (test)

Intervention Type PROCEDURE

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

Oral hygiene orientation and professional fluoride application

Intervention Type PROCEDURE

Oral hygiene orientation and professional fluoride application

Interventions

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Ionomer Restoration (control)

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

Intervention Type PROCEDURE

Ionomer Sealant (test)

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

Intervention Type PROCEDURE

Oral hygiene orientation and professional fluoride application

Intervention Type PROCEDURE

Other Intervention Names

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glass ionomer cement, restoration glass ionomer cement, sealant

Eligibility Criteria

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Inclusion Criteria

They will be included in this study children:

* aged 3 years and 6 years and 11 months;
* With complete primary dentition;
* Who have at least one active caries lesion score 3 or 4 ICDAS, in the occlusal molars surfaces.
* Who have assented to participate and whose parents have consented to their participation by signing the Instrument of Consent.

Exclusion Criteria

* who have medical and / or behavioral conditions that require special considerations regarding handling / treatment;
* who are involved in other research that may impact on this study;
* whose parents that not agree in participate.

Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No