Selective Dentine Removal in Primary Teeth

March 12, 2019 updated by: Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas

Selective Dentine Removal in Primary Teeth: a Randomized Clinical Trial

Background There is little information regarding the longevity of the restored tooth, considering the health of the pulp-dentine complex, in children who do not sufficiently cooperate with dental treatment.

Aim To evaluate the longevity of primary molar teeth with an occluso-proximal cavity that was treated with the selective removal of carious tissue.

Design A total of 150 children were allocated to two parallel groups: group 1 (G1, n = 70, control, Ketac Molar Easymix®, 3M/ESPE, Seefeld, GE) and group 2 (G2, n = 80, test, Maxxion®, FGM, Joinville, BR). The study was double-blinded, and an operator specialized in paediatric dentistry performed the selective removal of soft dentine and the restoration of the cavity with GIC. During the follow-up periods, the teeth were evaluated via periapical radiography by two trained examiners specialized in radiology. Statistical analysis was performed using Stata 11.2 software (StataCorp, Texas, USA) and a survival curve (Kaplan-Meier).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13045755
        • Faculty Sao Leopoldo Mandic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • An active denture caries lesion
  • The molars in primary, without anterior restoration, with the exclusive involvement of occlusal and mesial or distal surfaces present (International Caries Detection and Evaluation System, ICDAS score 5)

Exclusion Criteria:

  • Those who did not accept care after 3 adaptation sessions
  • Teeth with the following characteristics were excluded from the study: spontaneous pain, pressure sensitivity, suspected cellulose involvement, necrosis pulp, fistula, or tooth mobility
  • Teeth in which extension of the lesion could lead to pulpal exposure were excluded
  • Children whose parents or guardians do not sign an Informed Consent Term

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Molars subjected to selective removal and restored with Ketac Molar Easymix
Procedure: Control
Molars subjected to selective removal and restored with Ketac Molar Easymix
Experimental: Selective removal of caries and restoration with Maxxion
Molars subjected to selective removal and restored with Maxxion
Procedure: Selective removal of carious tissue and restoration with Maxxion
Molars subjected to selective removal and restored with Maxxion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of teeth with treatment-related success as assessed by radiographic analysis.
Time Frame: 14-month
To evaluate the longevity of primary molar teeth with an occluso-proximal cavity that was treated with the selective removal of carious tissue.
14-month
Number of teeth with treatment-related success as assessed by radiographic analysis.
Time Frame: 24-month
To evaluate the longevity of primary molar teeth with an occluso-proximal cavity that was treated with the selective removal of carious tissue.
24-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty Sao Leopoldo Mandic Campinas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2014

Primary Completion (Actual)

February 3, 2016

Study Completion (Actual)

February 3, 2017

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 9, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLM 7

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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