Efficacy of Guedes-Pinto Paste and CTZ Paste in the Non-instrumental Endodontic Treatment of Primary Teeth
1 other identifier
interventional
120
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedStudy Start
First participant enrolled
August 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2024
CompletedMay 17, 2023
May 1, 2023
7 months
October 7, 2020
May 15, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Radiographic Evaluation of the Changes in the Presence of Periapical Lesions in Each Treated Tooth
One month, 3 months and 6 months after treatment.
Study Arms (2)
Non-instrumental Endodontic Treatment (NIET) + Guedes-Pinto Paste Group
EXPERIMENTALIn this group, the canals will not be instrumented and the filling will be performed with Guedes-Pinto paste.
Non-instrumental Endodontic Treatment (NIET) + CTZ Paste Group
EXPERIMENTALIn this group, the canals will not be instrumented and the filling will be performed with CTZ paste (Chlorophenicol, Tetracycline and Zinc Oxide and Eugenol).
Interventions
Irrigation and aspiration in the root canals with 1% sodium hypochlorite (Milton's solution).
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nove de Julholead
- Universidade Metropolitana de Santoscollaborator
Related Publications (1)
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.
PMID: 37682887DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The clinical, radiographic and microbiological evaluations will be made by an assessor who will not know to which group the participants belong.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 7, 2020
First Posted
October 14, 2020
Study Start
August 20, 2023
Primary Completion
March 20, 2024
Study Completion
June 20, 2024
Last Updated
May 17, 2023
Record last verified: 2023-05