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Endodontic Treatment Using CTZ Paste in Primary Teeth

NCT03731975 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2018-12-24

No results posted yet for this study

Summary

The aim of this study is to evaluate the efficacy of CTZ Paste in primary teeth, compared to endodontic treatment with Guedes-Pinto Paste. This is a multicenter, randomized, double-blind (patient), controlled and non-inferiority clinical study on 174 primary molars and 174 primary incisors of 3-6 years-old children with carious lesions with pulp involvement. The sample unit will be the tooth, which will be randomized into two groups. The teeth allocated to the experimental group will be treated with CTZ Paste, whereas the treatment of those teeth allocated to the control group will employ the Guedes-Pinto Paste. The procedures performed will be evaluated clinically and radiographically at 6 and 12 months. Secondary outcomes such as cost, discomfort, satisfaction and quality of life will also be evaluated.

Conditions

  • Pulpectomy Agents

Interventions

PROCEDURE

CTZ Paste

Tooth allocated to this group will be treated with CTZ paste, according to the Cappielo's protocol (1964), updated by Moura et al. (2016).

PROCEDURE

GP Paste

Tooth allocated to this group will be treated with Guedes-Pinto paste, according to the Guedes-Pinto's protocol (1981), updated by Mello-Moura et al. (2011).

Sponsors & Collaborators

  • Faculty Sao Leopoldo Mandic Campinas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2018-12-01
Completion
2019-12-01

Countries

  • Brazil

Study Locations

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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 NCT03731975 on ClinicalTrials.gov