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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03704857
Other study ID # Endodontic therapy and symptom
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 30, 2017
Est. completion date March 30, 2023

Study information

Verified date April 2022
Source Universidade Federal Fluminense
Contact Lívia Antunes, PhD
Phone 55-21-987151919
Email liviaazeredo@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective: The objective of this study will be to evaluate the effectiveness of different endodontic treatment techniques in postoperative symptoms, apical repair, longevity of rehabilitations, and oral health-related quality of life. Methods: This prospective, randomized, double-blind clinical study was approved at the Research Ethics Committee (nº 2.353.996) and will consist of a sample of 350 patients who will be attended in the clinics of the Federal University of Fluminense/Institute of Health of Nova Friburgo (UFF/ISNF), in which they will be selected based on eligibility criteria. Patients aged up to 18 years, with teeth with necrotic pulps and radiographic evidence of periapical lesion will be included. These patients will be randomly divided into 8 groups: I (35 patients): unirradicular teeth will be submitted to endodontic treatment with foraminal enlargement, instrumentation with reciprocating rotation, sodium hypochlorite as irrigant, lateral condensation filling with MTA Fillapex; II (35 patients): unirradicular teeth will be submitted to endodontic treatment with foraminal enlargement, instrumentation with reciprocating rotation, sodium hypochlorite as irrigant, photobiomodulation (aPDT and LLLT), lateral condensation filling with MTA Fillapex; III (35 patients): unirradicular teeth will be submitted to endodontic treatment with foraminal enlargement, instrumentation with reciprocating rotation, chlorhexidine as irrigant, lateral condensation filling with MTA fillapex; IV (35 patients): unirradicular teeth will be submitted to endodontic treatment with foraminal enlargement, instrumentation with reciprocating rotation, sodium hypochlorite as irrigant, lateral condensation filling with AH Plus; V (35 patients): unirradicular teeth will be submitted to endodontic treatment with foraminal enlargement, instrumentation with reciprocating rotation, sodium hypochlorite as irrigant, cryotherapy with saline solution, lateral condensation filling with MTA Fillapex; VI (35 patients): unirradicular teeth will be submitted to endodontic treatment with foraminal enlargement, instrumentation with reciprocating rotation, sodium hypochlorite as irrigant, cryotherapy with saline solution, lateral condensation filling with AH Plus; VII (35 patients): unirradicular teeth will be submitted to endodontic treatment with foraminal enlargement, instrumentation with reciprocating rotation, sodium hypochlorite as irrigant, ozone therapy, lateral condensation filling with MTA Fillapex; VIII (35 patients): unirradicular teeth will be submitted to endodontic treatment with foraminal enlargement, instrumentation with reciprocating rotation, sodium hypochlorite as irrigant, ozone therapy, lateral condensation filling with AH Plus; IX (35 patients): molars will be submitted to endodontic treatment with foraminal enlargement, instrumentation with reciprocating rotation, conventional irrigation with sodium hypochlorite, lateral condensation filling with MTA fillapex; X (35 patients): molars will be submitted to endodontic treatment with foraminal enlargement, instrumentation with reciprocating rotation, passive ultrasonic irrigation with sodium hypochlorite, lateral condensation filling with MTA fillapex. The analysis of the postoperative symptoms will be performed by the visual analog pain scale at 1th, 2th, 3th, 4th, 5th, 6th, 7th, 14th and 30th days and by the clinical evaluation of edema in 48 and 72 hours. The periapical lesion repair will be evaluated clinically and radiographically at 3, 6, 12, 18 and 24 months. The longevity of rehabilitations will be performed clinically and radiographically for 24 months. In addition, patients will respond a quality of life questionnaire (OHIP-14) on the day of endodontic treatment, on the 7th day and on the 30th day. Data analysis: The data will be inserted into a statistical program (SPSS), obtaining the frequencies of the characterization variables of the sample. The appropriate tests will be used to compare the means of the groups.


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Study Design


Intervention

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Locations

Country Name City State
Brazil Lívia Azeredo Alves Antunes Nova Friburgo Rio De Janeiro

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain assessed by visual analog scale after endodontic treatment with enlargement of the apical foramen, in necrotic teeth and periapical lesion, and used photobiomodulation and different irrigating solutions. To assess clinically the relationship of photobiomodulation and different irrigating substances (sodium hypochlorite and chlorhexidine) with or without ultrasonic activation in postoperative pain evaluated through visual analog scale, after endodontic treatment with enlargement of the apical foramen, in necrotic teeth and periapical lesion. This scale is represented by a ruler from 0 to 10, in which zero means without pain and progressively to ten, severe pain. Postoperative pain will be assessed by visual analog scale to measure the change of pain in first, second, third, fourth, fifth, sixth, seventh, fourteenth, and thirtieth days.
Primary Edema assessed by photography after endodontic treatment with enlargement of the apical foramen, in necrotic teeth and periapical lesion, and used photobiomodulation and different irrigating solutions (sodium hypochlorite and chlorhexidine). To assess edema by photos after foraminal enlargement with photobiomodulation and different irrigating substances (sodium hypochlorite and chlorhexidine) with or without ultrasonic activation. Edema will be evaluated by photos in 48 and 72 hours. The photo will be taken from the face to assess the edema of the region after treatment.
Secondary Radiografic evaluation of apical repair after endodontic treatment with foraminal enlargement. Carry out the radiographic follow-up of the analyzed groups for 2 years in order to show periapical healing. Radiographs of each tooth will be performed using a standardized digital radiograph at 3, 6, 12, 18 and 24 months. The periapical repair will be determined through radiographs as cured, in the healing process and failure.
Secondary Clinical and radiographic evaluation of rehabilations after endodontic treatment with foraminal enlargement. Carry out clinical and radiographic follow-up of the groups analyzed for 2 years to demonstrate the longevity of rehabilitations. Clinical evaluation will be done through the examination of definitive restorations in adequate (any permanent restoration that appears radiographically intact); Inadequate (any permanent restoration with detectable radiographic signs of protrusions, fractured margins, recurrent caries) and missing. Definitive restorations will be evaluated in adequate; inadequate and missing.
Secondary Oral health-related quality of life assessed by OHIP-14, after endodontic treatment with enlargement of the apical foramen, in necrotic teeth and periapical lesion. To analyze the quality of life through a questionnaire (OHIP-14), before and after the endodontic treatment with foraminal enlargement in necrotic teeth and with periapical lesion. This questionnaire has 14 questions in which the patient answers between never (0), rarely (1), sometimes (2), repeatedly (3) and always (4), with maximum possible score reaching 56 points. OHIP-14 will be performed on the day of endodontic treatment, on the 7th day and on the 30th day. This questionnaire has 14 questions in which the patient answers between never (0), rarely (1), sometimes (2), repeatedly (3) and always (4).
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