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Different Endodontic Treatment Techniques in Postoperative Symptoms, Apical Repair, Longevity of Rehabilitations, and Oral Health-related Quality of Life

Primary Purpose

Endodontically Treated Teeth, Postoperative Pain, Edema

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Foraminal Enlargement / Irrigating solutions / Filling materials
Photobiomodulation
Passive ultrasonic irrigation
OHIP-14
Assessment of pain and edema
Assessment of periapical lesion
Longevity of rehabilitations
Cryotherapy
Ozone therapy
Sponsored by
Universidade Federal Fluminense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth focused on measuring Root canal Preparation, Foraminal enlargement, Photobiomodulation therapies, Postoperative symptoms, Passive ultrassonic irrigation, Irrigating solutions, Filling materials, Mouth Rehabilitation, Apical repair, Oral health-related quality of life, Antimicrobial photodynamic therapy, Low-level laser therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy individuals over 18 years of age.

  • Unirradicular teeth or molars with necrotic pulps and radiographic evidence of periapical lesion.

    • The state of the pulp will be determined by tests of sensitivity to cold and hot and confirmed by the absence of bleeding when accessing the pulp chamber.

Exclusion Criteria:

  • Patients with preoperative pain.
  • Patients with edema.
  • Individuals with systemic disorders and pregnant.
  • Positive history of antibiotic use in the last month.
  • Patients who require antibiotic pre-medication for dental treatment.
  • Positive history of analgesics in the previous 24 hours.

Sites / Locations

  • Lívia Azeredo Alves AntunesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Active Comparator

Experimental

Experimental

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Foraminal enlargement with sodium hypochlorite as irrigant

Foraminal enlargement with sodium hypochlorite and photobiomodulation

Foraminal enlargement with chlorhexidine as irrigant

Foraminal enlargement with sodium hypochlorite and AH Plus

Foraminal enlargement with conventional irrigation

Foraminal enlargement with passive ultrasonic irrigation

Foraminal enlargement with cryotherapy

Foraminal enlargement with cryotherapy and AH Plus

Foraminal enlargement with ozone therapy

Foraminal enlargement with ozone therapy and AH Plus

Arm Description

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. 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.

Unirradicular teeth will be submitted to endodontic treatment with foraminal enlargement, instrumentation with reciprocating rotation, sodium hypochlorite as irrigant, photobiomodulation (antimicrobial photodynamic therapy and low-level laser therapy), 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.

Unirradicular teeth will be submitted to endodontic treatment with foraminal enlargement, instrumentation with reciprocating rotation, chlorhexidine as irrigant, 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.

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.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.

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. 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.

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.

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. 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.

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. 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.

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. 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.

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. 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 16, 2018
Last Updated
April 26, 2022
Sponsor
Universidade Federal Fluminense
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1. Study Identification

Unique Protocol Identification Number
NCT03704857
Brief Title
Different Endodontic Treatment Techniques in Postoperative Symptoms, Apical Repair, Longevity of Rehabilitations, and Oral Health-related Quality of Life
Official Title
Evaluation of the Effectiveness of Different Endodontic Treatment Techniques in Postoperative Symptoms, Apical Repair, Longevity of Rehabilitations, and Oral Health-related Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal Fluminense

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth, Postoperative Pain, Edema, Photochemotherapy
Keywords
Root canal Preparation, Foraminal enlargement, Photobiomodulation therapies, Postoperative symptoms, Passive ultrassonic irrigation, Irrigating solutions, Filling materials, Mouth Rehabilitation, Apical repair, Oral health-related quality of life, Antimicrobial photodynamic therapy, Low-level laser therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Foraminal enlargement with sodium hypochlorite as irrigant
Arm Type
Active Comparator
Arm Description
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. 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.
Arm Title
Foraminal enlargement with sodium hypochlorite and photobiomodulation
Arm Type
Experimental
Arm Description
Unirradicular teeth will be submitted to endodontic treatment with foraminal enlargement, instrumentation with reciprocating rotation, sodium hypochlorite as irrigant, photobiomodulation (antimicrobial photodynamic therapy and low-level laser therapy), 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.
Arm Title
Foraminal enlargement with chlorhexidine as irrigant
Arm Type
Experimental
Arm Description
Unirradicular teeth will be submitted to endodontic treatment with foraminal enlargement, instrumentation with reciprocating rotation, chlorhexidine as irrigant, 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.
Arm Title
Foraminal enlargement with sodium hypochlorite and AH Plus
Arm Type
Active Comparator
Arm Description
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.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.
Arm Title
Foraminal enlargement with conventional irrigation
Arm Type
Active Comparator
Arm Description
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. 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.
Arm Title
Foraminal enlargement with passive ultrasonic irrigation
Arm Type
Experimental
Arm Description
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.
Arm Title
Foraminal enlargement with cryotherapy
Arm Type
Experimental
Arm Description
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. 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.
Arm Title
Foraminal enlargement with cryotherapy and AH Plus
Arm Type
Experimental
Arm Description
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. 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.
Arm Title
Foraminal enlargement with ozone therapy
Arm Type
Experimental
Arm Description
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. 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.
Arm Title
Foraminal enlargement with ozone therapy and AH Plus
Arm Type
Experimental
Arm Description
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. 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.
Intervention Type
Other
Intervention Name(s)
Foraminal Enlargement / Irrigating solutions / Filling materials
Intervention Description
Instrumentation with foraminal enlargement and various irrigation solutions and filling materials will be performed according to the allocated group. The foraminal enlargement provides better results in the bacterial removal of the apical portion of the root canal. This instrumentation will be done with the Reciproc 40 or 50 system in the apical foramen, determined by the apical locator. To contribute to disinfection of the root canal, sodium hypochlorite and chlorhexidine are the most widely used irrigators. Sodium hypochlorite has a broad antimicrobial spectrum and an effective ability to dissolve organic matter and necrotic tissue; while chlorhexidine shows substantivity and antimicrobial residual activity when used as an irrigating substance. Besides that, MTA Fillapex or AH Plus will be used and the recommended filling technique will be lateral condensation.
Intervention Type
Other
Intervention Name(s)
Photobiomodulation
Intervention Description
aPDT will be performed with 0.01% methylene blue solution and it will be inserted into the root canal for 5 minutes. The excess will be removed and irradiation will be performed inside the root canal with the red laser of Índio Gálio Alumínio Fósforo (660nm, Laser Duo, MMOptics, São Paulo, SP, Brazil) for 90 seconds. Laser therapy with Gallium-Aluminum-Arsenic infrared laser (808nm, Laser Duo, MMOptics, São Paulo, SP, Brazil) will be performed on the gingiva from the vestibular face and on the palatal / lingual face, both located in the periapical region for 40 seconds.
Intervention Type
Other
Intervention Name(s)
Passive ultrasonic irrigation
Intervention Description
PUI will be performed with Newtron P5 ultrasound (Satelec / Acteon Group, Bordeaux, France), at intensity 9 and with a 25mm (# 0.25, taper 0.00). The protocol of use will be 3 sequences of 20 seconds of ultrasonic activation with 2 ml of sodium hypochlorite 2.5% in each root canal.
Intervention Type
Other
Intervention Name(s)
OHIP-14
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Assessment of pain and edema
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Assessment of periapical lesion
Intervention Description
The periapical lesion repair will be evaluated clinically and radiographically at 3, 6, 12, 18 and 24 months.
Intervention Type
Other
Intervention Name(s)
Longevity of rehabilitations
Intervention Description
The teeth will be rehabilitated with resin and glass fiber post. The longevity of rehabilitations will be performed clinically and radiographically for 24 months.
Intervention Type
Other
Intervention Name(s)
Cryotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Ozone therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
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.
Title
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).
Description
To assess edema by photos after foraminal enlargement with photobiomodulation and different irrigating substances (sodium hypochlorite and chlorhexidine) with or without ultrasonic activation.
Time Frame
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 Outcome Measure Information:
Title
Radiografic evaluation of apical repair after endodontic treatment with foraminal enlargement.
Description
Carry out the radiographic follow-up of the analyzed groups for 2 years in order to show periapical healing.
Time Frame
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.
Title
Clinical and radiographic evaluation of rehabilations after endodontic treatment with foraminal enlargement.
Description
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.
Time Frame
Definitive restorations will be evaluated in adequate; inadequate and missing.
Title
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.
Description
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.
Time Frame
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy individuals over 18 years of age. Unirradicular teeth or molars with necrotic pulps and radiographic evidence of periapical lesion. The state of the pulp will be determined by tests of sensitivity to cold and hot and confirmed by the absence of bleeding when accessing the pulp chamber. Exclusion Criteria: Patients with preoperative pain. Patients with edema. Individuals with systemic disorders and pregnant. Positive history of antibiotic use in the last month. Patients who require antibiotic pre-medication for dental treatment. Positive history of analgesics in the previous 24 hours.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lívia Antunes, PhD
Phone
55-21-987151919
Email
liviaazeredo@gmail.com
Facility Information:
Facility Name
Lívia Azeredo Alves Antunes
City
Nova Friburgo
State/Province
Rio De Janeiro
ZIP/Postal Code
28.625-650
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lívia Antunes, PhD
Phone
55-21-987151919
Email
liviaazeredo@gmail.com
First Name & Middle Initial & Last Name & Degree
Lívia Antunes, PhD
First Name & Middle Initial & Last Name & Degree
Leonardo Antunes, PhD
First Name & Middle Initial & Last Name & Degree
Ludmila Guimarães, PhD Student
First Name & Middle Initial & Last Name & Degree
Erlange Silva, PhD Student

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Different Endodontic Treatment Techniques in Postoperative Symptoms, Apical Repair, Longevity of Rehabilitations, and Oral Health-related Quality of Life

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