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

Necrotic Pulp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04587089
• Other study ID #: EndoDeciduos
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: August 20, 2023
• Est. completion date: June 20, 2024

Study information

• Verified date: May 2023
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 20, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrotic Pulp

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Nove de Julho	Universidade Metropolitana de Santos

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Investigation of the Change in the Presence of Fistulas in Each Treated Tooth	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.
Primary	Clinical Investigation of Changes in Tooth Mobility in Each Treated Tooth	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	Radiographic Evaluation of the Changes in the Presence of Periapical Lesions in Each Treated Tooth	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.