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

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ClinicalTrials.gov Identifier: NCT03005405
Recruitment Status : Active, not recruiting
First Posted : December 29, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Mariana Minatel Braga, University of Sao Paulo

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 Not Applicable

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  (Clinical Trial)
Estimated 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 : February 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

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 Name: 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 Name: glass ionomer cement, sealant

Procedure: Oral hygiene orientation and professional fluoride application
Oral hygiene orientation and professional fluoride application




Primary Outcome Measures :
  1. Need of reintervention [ Time Frame: 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 :
  1. Child's reported discomfort [ Time Frame: 1st day ]
    The discomfort will be an outcome collected right after the end of treatment, using Wong baker scale

  2. Duration of treatments [ Time Frame: 1st day ]
    Time spent in interventions will be recorded.



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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03005405


Locations
Brazil
University of São Paulo
São Paulo, SP, Brazil, 05508-000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Mariana M Braga, PhD University of São Paulo

Responsible Party: Mariana Minatel Braga, PhD, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03005405     History of Changes
Other Study ID Numbers: SEALANT-CARDEC02
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication of all results, accessibility to data if necessary

Keywords provided by Mariana Minatel Braga, University of Sao Paulo:
Dental Caries
Primary tooth
Ionomer Sealants
Glass Ionomer Restoration

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Methamphetamine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors