Efficacy of Guedes-Pinto Paste and CTZ Paste in the Non-instrumental Endodontic Treatment of Primary Teeth

May 15, 2023 updated by: Sandra Kalil Bussadori, University of Nove de Julho

Efficacy of Guedes-Pinto Paste and CTZ Paste in the Non-instrumental Endodontic Treatment of Primary Teeth - Study Protocol for a Randomized Controlled Clinical Trial

The maintenance of the deciduous tooth until its physiological exfoliation occurs is one of the main objectives of pediatric dentistry. Endodontic treatment in deciduous teeth resulting from carious or traumatic lesions with pulpal involvement is often necessary and we often find it difficult to perform it, due to the difficult control of the child, the internal anatomy of the root canals, and root resorptions. The non-instrumental endodontic treatment technique (TENI) associated with antimicrobial drugs has advantages such as shorter chair time and less complexity than the conventional technique in which root canal instrumentation is performed. The objective of this study is to carry out a controlled and randomized clinical trial to compare the effectiveness of non-instrumental endodontic treatment (NIET) in primary teeth associated with the use of two filling pastes. 120 necrotic deciduous teeth of children aged between 3 and 6 years will be selected; and the teeth will be divided into two groups. In Group 1 and Group 2, the root canals will not be instrumented, just irrigated and filled with the respective pastes, CTZ and Guedes-Pinto. The radiographic aspects will be evaluated, considering the repair process, clinically will be evaluated: presence of fistula and mobility, the evaluations will be carried out in both groups on the day of treatment and in periods of 1, 3 and 6 months after treatment. The data obtained will be submitted to the Shapiro-Wilk normality test, where the statistical analysis that will be used for this study will be defined, adopting a significance level of 95% (p<0.05).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 1

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

3 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients aged 3 to 6 years old with at least one anterior deciduous tooth with pulp necrosis in a position to be restored and at least 2/3 of the remaining root.
  • Healthy patients and who did not antibiotic treatment in the previous three months.

Exclusion Criteria:

• Compromised health, primary teeth with more than one third root loss, lack of internal pathological resorption, impossibility of restoration, cases of re-treatment and crypt involvement.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-instrumental Endodontic Treatment (NIET) + Guedes-Pinto Paste Group
In this group, the canals will not be instrumented and the filling will be performed with Guedes-Pinto paste.
Procedure: Filling with Guedes-Pinto Paste
The root canals will be filled with Guedes-Pinto Paste, which is a composite of 3 medications: Rifocort® (dermatologic ointment), camphorated paramonochlorophenol (PMCC) and iodoform. It will be prepared at the moment of use with the same proportion in volume of 3 visually identical parts, one for each of its components.
Procedure: Irrigation
Irrigation and aspiration in the root canals with 1% sodium hypochlorite (Milton's solution).
Experimental: Non-instrumental Endodontic Treatment (NIET) + CTZ Paste Group
In this group, the canals will not be instrumented and the filling will be performed with CTZ paste (Chlorophenicol, Tetracycline and Zinc Oxide and Eugenol).
Procedure: Irrigation
Irrigation and aspiration in the root canals with 1% sodium hypochlorite (Milton's solution).
Procedure: Filling with CTZ Paste
The powder that composes the CTZ paste will be previously manipulated in a 1:1:2 ratio (500mg of Chloramphenicol, 500mg of Tetracycline and 1,000mg of Zinc Oxide) by Formula & Ação (F&A) and incorporated into the eugenol liquid at the time of use, with the aid of a flexible spatula nº 24 and on a sterile glass plate. The cleaning of the coronary chamber must be carried out with saline solution and drying with sterile cotton balls and the CTZ paste must be inserted into the cavity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Investigation of the Change in the Presence of Fistulas in Each Treated Tooth
Time Frame: Baseline, one month, 3 months and 6 months after treatment.
In the follow-up consultations, teeth and gums will be clinically evaluated to check the presence of fistulas.
Baseline, one month, 3 months and 6 months after treatment.
Clinical Investigation of Changes in Tooth Mobility in Each Treated Tooth
Time Frame: Baseline, one month, 3 months and 6 months after treatment.
In the follow-up consultations, teeth will be clinically evaluated to check the presence of mobility.
Baseline, one month, 3 months and 6 months after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Evaluation of the Changes in the Presence of Periapical Lesions in Each Treated Tooth
Time Frame: One month, 3 months and 6 months after treatment.
In the follow-up consultations, periapical radiographs will be taken to check for the presence of periapical lesions.
One month, 3 months and 6 months after treatment.

Collaborators and Investigators

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

Sponsor

University of Nove de Julho

Collaborators

Universidade Metropolitana de Santos

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 (Anticipated)

August 20, 2023

Primary Completion (Anticipated)

March 20, 2024

Study Completion (Anticipated)

June 20, 2024

Study Registration Dates

First Submitted

October 7, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EndoDeciduos

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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