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Comparison of Conventional Versus Conservative Caries Removal in Primary Teeth

NCT03650647 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2018-08-29

No results posted yet for this study

Summary

The sample will be, at least, 90 primary molars, randomly distributed into three groups: Group 1: IPC; Group 2: SE; Group 3: SCR. Teeth must present deep caries lesions (at least 2/3 of dentin depth), pulp vitality (no clinical or radiographical signs of pulp disease, such as abcesses, fistulae, root resorption, abnormal tooth mobility). This study received approval by the Ethics Committee of Fluminense Federal University (UFF; Brazil) - # CAAE: 58812816.8.0000.5626. The study started in January, 2017; and will finish in December, 2020. Patients will be selected from the public schools in Nova Friburgo. The dental exams and treatment procedures will be done at the clinics from the

School of Dentistry, Health Institute of Nova Friburgo (ISNF). Laboratory proceedings will be done at:

* Clinical and Microbiological Research Laboratory (LAB PECMA - ISNF) - Sample storage, bacterial cultivation and identification.
* University of North Carolina at Chapel Hill
* Rio de Janeiro Federal University

Conditions

  • Dental Caries Extending Into Dentin

Interventions

PROCEDURE

Carious dentin removal

Carious tissue removal and managing deep cavitated carious lesions in primary teeth.

Sponsors & Collaborators

  • Universidade Federal Fluminense

    lead OTHER

Principal Investigators

  • Apoena A Ribeiro, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-15
Primary Completion
2018-01-15
Completion
2020-01-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03650647 on ClinicalTrials.gov