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

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03005405
• Other study ID #: SEALANT-CARDEC02
• Status: Active, not recruiting
• Phase: N/A
• First received: August 17, 2016
• Last updated: March 20, 2018
• Start date: February 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Procedure:
• Ionomer Restoration (control)
Restoration of moderate caries lesions after partial caries removal using high viscosity glass ionomer cements
• Ionomer Sealant (test)
Sealing of moderate caries lesions without any caries removal or cavity opening.
• Oral hygiene orientation and professional fluoride application
Oral hygiene orientation and professional fluoride application

Locations

Country	Name	City	State
Brazil	University of São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need of reintervention	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.	24 months
Secondary	Child's reported discomfort	The discomfort will be an outcome collected right after the end of treatment, using Wong baker scale	1st day
Secondary	Duration of treatments	Time spent in interventions will be recorded.	1st day