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

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

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.

Study Overview

• Status: Unknown
• Conditions: Dental Caries
• Intervention / Treatment: Procedure: Ionomer Restoration (control); Procedure: Oral hygiene orientation and professional fluoride application; Procedure: Ionomer Sealant (test)

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 Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05508-000
      • University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Oral hygiene orientation and professional fluoride application; Oral hygiene orientation and professional fluoride application; Procedure: Ionomer Sealant (test); Sealing of moderate caries lesions without any caries removal or cavity opening.; Other Names: glass ionomer cement, sealant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Mariana M Braga, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: December 23, 2016
• First Posted (Estimate): December 29, 2016

Study Record Updates

• Last Update Posted (Actual): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Dental Caries; Primary tooth; Ionomer Sealants; Glass Ionomer Restoration
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Cariostatic Agents; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Fluorides; Methamphetamine
• Other Study ID Numbers: SEALANT-CARDEC02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Publication of all results, accessibility to data if necessary