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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03704857
• Other study ID #: Endodontic therapy and symptom
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: March 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Endodontically Treated Teeth
• Photochemotherapy
• Postoperative Pain
• Tooth, Nonvital

Intervention

Other:
• Foraminal Enlargement / Irrigating solutions / Filling materials
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.
• Photobiomodulation
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.
• Passive ultrasonic irrigation
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.
• OHIP-14
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.
• Assessment of pain and edema
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.
• Assessment of periapical lesion
The periapical lesion repair will be evaluated clinically and radiographically at 3, 6, 12, 18 and 24 months.
• Longevity of rehabilitations
The teeth will be rehabilitated with resin and glass fiber post. The longevity of rehabilitations will be performed clinically and radiographically for 24 months.
• Cryotherapy
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.
• Ozone therapy
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.

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).