Clinical trial NCT03839485: Endodontic Treatment of Primary Teeth With Guedes-Pinto Paste Without Antibiotic
Official title: Endodontic Treatment of Primary Teeth With Guedes-Pinto Paste Without Antibiotic: Randomized Non-inferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulp Disorder
Keywords: pulpectomy
primary teeth
root canal filling materials
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The pulp therapy in primary teeth is still necessary even with all odontopediatrics evolution in prevention and minimal intervention, aiming to keep the tooth free of inflammation or infection and in a functional state until its exfoliation. Several materials are used as filling paste of primary teeth. In Brazil, the Guedes-Pinto Paste (PGP), an association of iodofórmio, camphorated paramonochlorophenol, prednisolone and rifamycin, has been widely used for some decades. However, current Brazilian legislation has made it difficult to commercialize antibiotics, which has made it difficult to obtain the ointment that is the association between prednisolone and rifamycin. Therefore, the objective of this clinical trial will be to test PGP without rifamycin in the pulpectomy of primary teeth, and to compare it with the treatment performed with conventional PGP.

Detailed description: A randomized triple-blind non-inferiority clinical study with two parallel arms, with a 12-month follow-up, will be performed. The experimental group will be PGP formulated without the antibiotic, while the control group is the conventional PGP, containing rifamycin. The conventional pulpectomy will be performed using manual files, performing the instrumentation aided by Endo-PTC and 1% sodium hypochlorite. At the end of the instrumentation, just before the obturation, the groups will be drawn, with the strategy of randomization in permuted blocks and stratified by the initial condition of the tooth (with or without periapical lesion). The main outcome will be the clinical and radiographic success of endodontic treatment after 12 months. Patients who seek the dental service of the municipality and require endodontic treatment will be invited to participate in the study. The data will be statistically analyzed using the statistical package Stata 12.0 (Stata Corporation, College Station, TX, USA). The longevity of the treatments will be evaluated by estimating survival rates using the Kaplan-Meier method. The differences between survival rates according to the type of endodontic treatment proposed will be analyzed through the Log-rank test.

Eligibility criteria: Inclusion Criteria:

* Primary molar teeth with necessity of endodontic treatment.
* Patients whose parents or guardians consent to their participation in the study

Exclusion Criteria:

* Systemic health problems, congenital facial deformities, facial tumors or syndromes
* Teeth presenting one of the following:

  * Resorption of more than 2/3 of the root
  * Destruction of the crypt of the permanent successor
  * Pulp chamber floor drilling.
  * Presence of internal resorption

Primary outcomes:
measure: Success or failure of treatment
timeFrame: 1 year
Secondary outcomes:
measure: Post-operative fistula
timeFrame: 7 days
measure: Post-operative pain
timeFrame: 7 days
measure: Post-operatve oedema
timeFrame: 7 days
measure: Quality of root canal filling
timeFrame: Imediatelly after the treatment
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: School of Dentistry, University of Sao Paulo
Study officials:
References: