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

Sponsor

University of Sao Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT03005405

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Procedure: Ionomer Restoration (control) Procedure: Ionomer Sealant (test) Procedure: Oral hygiene orientation and professional fluoride application	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Cost-efficacy and Applicability of the Treatment of Moderate Caries Using Sealants as an Alternative to the Restorations on Occlusal Surfaces of Deciduous Teeth: a Randomized Controlled Trial

Study Start Date :

Feb 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: restoration - control Restoration	Procedure: Ionomer Restoration (control) Restoration of moderate caries lesions after partial caries removal using high viscosity glass ionomer cements Other Names: glass ionomer cement, restoration Procedure: Oral hygiene orientation and professional fluoride application Oral hygiene orientation and professional fluoride application
Experimental: sealant - test Sealant	Procedure: Ionomer Sealant (test) Sealing of moderate caries lesions without any caries removal or cavity opening. Other Names: glass ionomer cement, sealant Procedure: Oral hygiene orientation and professional fluoride application Oral hygiene orientation and professional fluoride application

Arm

Intervention/Treatment

Active Comparator: restoration - control

Restoration

Procedure: Ionomer Restoration (control)

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

Other Names:

glass ionomer cement, restoration

Procedure: Oral hygiene orientation and professional fluoride application

Oral hygiene orientation and professional fluoride application

Experimental: sealant - test

Sealant

Procedure: Ionomer Sealant (test)

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

Other Names:

glass ionomer cement, sealant

Procedure: Oral hygiene orientation and professional fluoride application

Oral hygiene orientation and professional fluoride application

Outcome Measures

Primary Outcome Measures

Need of reintervention [24 months]
Need of reintervention will be considered as all failures after initial treatment that demand repair and/or caries progression associated to the treated lesion at baseline. After cleaning, It will be analyzed the clinical evaluation of restorations and sealants, will be assessed the presence of caries lesions in dentin and / or evolution of ICDAS scores and if will be necessary other types of treatment, such as endodontics and extraction of teeth included.

Secondary Outcome Measures

Child's reported discomfort [1st day]
The discomfort will be an outcome collected right after the end of treatment, using Wong baker scale
Duration of treatments [1st day]
Time spent in interventions will be recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.