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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
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotic Pulp

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 7, 2020
    Last Updated
    May 15, 2023
    Sponsor
    University of Nove de Julho
    Collaborators
    Universidade Metropolitana de Santos
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    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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