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

NCT ID: NCT04587089

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-20
• Study Completion Date: 2024-06-20

Brief Summary

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).

Conditions

Necrotic Pulp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Irrigation

Intervention Type: PROCEDURE

Irrigation and aspiration in the root canals with 1% sodium hypochlorite (Milton's solution).

Filling with Guedes-Pinto Paste

Intervention Type: PROCEDURE

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.

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).

Group Type: EXPERIMENTAL

Irrigation

Intervention Type: PROCEDURE

Irrigation and aspiration in the root canals with 1% sodium hypochlorite (Milton's solution).

Filling with CTZ Paste

Intervention Type: PROCEDURE

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.

Interventions

Irrigation

Irrigation and aspiration in the root canals with 1% sodium hypochlorite (Milton's solution).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Metropolitana de Santos

OTHER

Sponsor Role: collaborator

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Sobral APT, Santos EM, Leal Goncalves ML, Ferri EP, Junior WSB, Gimenez T, Gallo JMAS, Horliana ACRT, Motta LJ, Kalil Bussadori S. Efficacy of antibiotic and iodoform pastes in non-instrumental endodontic treatment of anterior primary teeth-Protocol for a randomized controlled clinical. PLoS One. 2023 Sep 8;18(9):e0291133. doi: 10.1371/journal.pone.0291133. eCollection 2023.

Reference Type: DERIVED

PMID: 37682887 (View on PubMed)

Other Identifiers

EndoDeciduos

Identifier Type: -

Identifier Source: org_study_id