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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Necrotic Pulp

Intervention / Treatment
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* Procedure: Irrigation
* Procedure: Filling with Guedes-Pinto Paste
* Procedure: Filling with CTZ Paste


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-instrumental Endodontic Treatment (NIET) + Guedes-Pinto Paste Group<br>In this group, the canals will not be instrumented and the filling will be performed with Guedes-Pinto paste. | Procedure: Irrigation<br>* Irrigation and aspiration in the root canals with 1% sodium hypochlorite (Milton's solution).<br>Procedure: Filling with Guedes-Pinto Paste<br>* 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.<br>|
| Experimental: Non-instrumental Endodontic Treatment (NIET) + CTZ Paste Group<br>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<br>* Irrigation and aspiration in the root canals with 1% sodium hypochlorite (Milton's solution).<br>Procedure: Filling with CTZ Paste<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |