NCT03005405

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

3.8 years

First QC Date

August 17, 2016

Last Update Submit

March 20, 2018

Conditions

Dental Caries

Keywords

Dental CariesPrimary toothIonomer SealantsGlass Ionomer Restoration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Child's reported discomfort

    1st day

  • Duration of treatments

    1st day

Study Arms (2)

restoration - control

ACTIVE COMPARATOR

Restoration

Procedure: Ionomer Restoration (control)Procedure: Oral hygiene orientation and professional fluoride application

sealant - test

EXPERIMENTAL

Sealant

Procedure: Ionomer Sealant (test)Procedure: Oral hygiene orientation and professional fluoride application

Interventions

Ionomer Restoration (control)PROCEDURE

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

Also known as: glass ionomer cement, restoration
restoration - control
Ionomer Sealant (test)PROCEDURE

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

Also known as: glass ionomer cement, sealant
sealant - test
Oral hygiene orientation and professional fluoride applicationPROCEDURE

Oral hygiene orientation and professional fluoride application

restoration - controlsealant - test

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Glass Ionomer Cements

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental CementsDental MaterialsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Mariana M Braga, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Associate Professor

Study Record Dates

First Submitted

August 17, 2016

First Posted

December 29, 2016

Study Start

February 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 22, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share

Publication of all results, accessibility to data if necessary

Locations

BR(1)