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
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- University of Nove de Julho
- Enrollment
- 120
- Primary Endpoint
- Clinical Investigation of Changes in Tooth Mobility in Each Treated Tooth
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The clinical, radiographic and microbiological evaluations will be made by an assessor who will not know to which group the participants belong.
Eligibility Criteria
- Ages
- 3 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Irrigation (Procedure)
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.
Intervention: Filling with Guedes-Pinto Paste (Procedure)
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).
Intervention: Irrigation (Procedure)
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).
Intervention: Filling with CTZ Paste (Procedure)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Radiographic Evaluation of the Changes in the Presence of Periapical Lesions in Each Treated Tooth(One month, 3 months and 6 months after treatment.)
Investigators
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho