Efficacy of Guedes-Pinto Paste and CTZ Paste in the Non-instrumental Endodontic Treatment of Primary Teeth
Primary Purpose
Necrotic Pulp
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Irrigation
Filling with Guedes-Pinto Paste
Filling with CTZ Paste
Sponsored by
About this trial
This is an interventional treatment trial for Necrotic Pulp
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Non-instrumental Endodontic Treatment (NIET) + Guedes-Pinto Paste Group
Non-instrumental Endodontic Treatment (NIET) + CTZ Paste Group
Arm Description
In this group, the canals will not be instrumented and the filling will be performed with Guedes-Pinto paste.
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).
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04587089
First Posted
October 7, 2020
Last Updated
May 15, 2023
Sponsor
University of Nove de Julho
Collaborators
Universidade Metropolitana de Santos
1. Study Identification
Unique Protocol Identification Number
NCT04587089
Brief Title
Efficacy of Guedes-Pinto Paste and CTZ Paste in the Non-instrumental Endodontic Treatment of Primary Teeth
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 20, 2023 (Anticipated)
Primary Completion Date
March 20, 2024 (Anticipated)
Study Completion Date
June 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
Universidade Metropolitana de Santos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotic Pulp
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-instrumental Endodontic Treatment (NIET) + Guedes-Pinto Paste Group
Arm Type
Experimental
Arm Description
In this group, the canals will not be instrumented and the filling will be performed with Guedes-Pinto paste.
Arm Title
Non-instrumental Endodontic Treatment (NIET) + CTZ Paste Group
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Irrigation
Intervention Description
Irrigation and aspiration in the root canals with 1% sodium hypochlorite (Milton's solution).
Intervention Type
Procedure
Intervention Name(s)
Filling with Guedes-Pinto Paste
Intervention Description
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
Intervention Name(s)
Filling with CTZ Paste
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Investigation of the Change in the Presence of Fistulas in Each Treated Tooth
Description
In the follow-up consultations, teeth and gums will be clinically evaluated to check the presence of fistulas.
Time Frame
Baseline, one month, 3 months and 6 months after treatment.
Title
Clinical Investigation of Changes in Tooth Mobility in Each Treated Tooth
Description
In the follow-up consultations, teeth will be clinically evaluated to check the presence of mobility.
Time Frame
Baseline, one month, 3 months and 6 months after treatment.
Secondary Outcome Measure Information:
Title
Radiographic Evaluation of the Changes in the Presence of Periapical Lesions in Each Treated Tooth
Description
In the follow-up consultations, periapical radiographs will be taken to check for the presence of periapical lesions.
Time Frame
One month, 3 months and 6 months after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Guedes-Pinto Paste and CTZ Paste in the Non-instrumental Endodontic Treatment of Primary Teeth
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