Endodontically Treated TeethNCT03704857
Different Endodontic Treatment Techniques in Postoperative Symptoms, Apical Repair, Longevity of Rehabilitations, and Oral Health-related Quality of Life
A study testing Foraminal Enlargement / Irrigating solutions / Filling materials, Photobiomodulation and Passive ultrasonic irrigation in people with Endodontically Treated Teeth and Postoperative Pain, run by Universidade Federal Fluminense at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth, Postoperative Pain, Edema
- What is being tested?
- Foraminal Enlargement / Irrigating solutions / Filling materials, Photobiomodulation and Passive ultrasonic irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Oct 2017to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Lívia Azeredo Alves Antunes
Nova Friburgo, Rio de Janeiro, 28.625-650
Lívia Antunes, PhD, 55-21-987151919, liviaazeredo@gmail.com
Lívia Antunes, PhD
About this study
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
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.
- Being tested
- Foraminal Enlargement / Irrigating solutions / Filling materials, Photobiomodulation, Passive ultrasonic irrigation, OHIP-14, Assessment of pain and edema
- 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
- Medical subject headings
- Tooth, Nonvital, Pain, Postoperative, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foraminal Enlargement / Irrigating solutions / Filling materialsOther
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.
PhotobiomodulationOther
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 irrigationOther
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-14Other
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 edemaOther
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 lesionOther
The periapical lesion repair will be evaluated clinically and radiographically at 3, 6, 12, 18 and 24 months.
Longevity of rehabilitationsOther
The teeth will be rehabilitated with resin and glass fiber post. The longevity of rehabilitations will be performed clinically and radiographically for 24 months.
CryotherapyOther
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Foraminal enlargement with sodium hypochlorite as irrigant | Active comparator | 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. Receives: Other: Foraminal Enlargement / Irrigating solutions / Filling materials; Other: OHIP-14; Other: Assessment of pain and edema; Other: Assessment of periapical lesion; Other: Longevity of rehabilitations |
| Foraminal enlargement with sodium hypochlorite and photobiomodulation | Experimental | 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. Receives: Other: Foraminal Enlargement / Irrigating solutions / Filling materials; Other: Photobiomodulation; Other: OHIP-14; Other: Assessment of pain and edema; Other: Assessment of periapical lesion; Other: Longevity of rehabilitations |
| Foraminal enlargement with chlorhexidine as irrigant | Experimental | 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. Receives: Other: Foraminal Enlargement / Irrigating solutions / Filling materials; Other: OHIP-14; Other: Assessment of pain and edema; Other: Assessment of periapical lesion; Other: Longevity of rehabilitations |
| Foraminal enlargement with sodium hypochlorite and AH Plus | Active comparator | 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. Receives: Other: Foraminal Enlargement / Irrigating solutions / Filling materials; Other: OHIP-14; Other: Assessment of pain and edema; Other: Assessment of periapical lesion; Other: Longevity of rehabilitations |
| Foraminal enlargement with conventional irrigation | Active comparator | 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. Receives: Other: Foraminal Enlargement / Irrigating solutions / Filling materials; Other: OHIP-14; Other: Assessment of pain and edema; Other: Assessment of periapical lesion; Other: Longevity of rehabilitations |
| Foraminal enlargement with passive ultrasonic irrigation | Experimental | 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. Receives: Other: Foraminal Enlargement / Irrigating solutions / Filling materials; Other: Passive ultrasonic irrigation; Other: OHIP-14; Other: Assessment of pain and edema; Other: Assessment of periapical lesion; Other: Longevity of rehabilitations |
| Foraminal enlargement with cryotherapy | Experimental | 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. Receives: Other: Foraminal Enlargement / Irrigating solutions / Filling materials; Other: OHIP-14; Other: Assessment of pain and edema; Other: Assessment of periapical lesion; Other: Longevity of rehabilitations; Other: Cryotherapy |
| Foraminal enlargement with cryotherapy and AH Plus | Experimental | 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. Receives: Other: Foraminal Enlargement / Irrigating solutions / Filling materials; Other: OHIP-14; Other: Assessment of pain and edema; Other: Assessment of periapical lesion; Other: Longevity of rehabilitations; Other: Cryotherapy |
| Foraminal enlargement with ozone therapy | Experimental | 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. Receives: Other: Foraminal Enlargement / Irrigating solutions / Filling materials; Other: OHIP-14; Other: Assessment of pain and edema; Other: Assessment of periapical lesion; Other: Longevity of rehabilitations; Other: Ozone therapy |
| Foraminal enlargement with ozone therapy and AH Plus | Experimental | 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. Receives: Other: Foraminal Enlargement / Irrigating solutions / Filling materials; Other: OHIP-14; Other: Assessment of pain and edema; Other: Assessment of periapical lesion; Other: Longevity of rehabilitations; Other: Ozone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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 outcomes (3)
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.
Measured: 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.
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.
Measured: Definitive restorations will be evaluated in adequate; inadequate 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start30 Oct 2017
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically Treated TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livia Azeredo Alves Antunes, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704857
- Sponsor's protocol ID
- Endodontic therapy and symptom
- Status last verified
- Apr 2022
- First submitted
- 16 Aug 2018
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03704857
- Acronym / sponsor ID
- Endodontic therapy and symptom
- Keywords
- Root canal Preparation, Foraminal enlargement, Photobiomodulation therapies, Postoperative symptoms, Passive ultrassonic irrigation, Irrigating solutions, Filling materials, Mouth Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Foraminal enlargement with sodium hypochlorite as irrigant | Active comparator | Other: Foraminal Enlargement / Irrigating solutions / Filling materials, Other: OHIP-14, Other: Assessment of pain and edema, Other: Assessment of periapical lesion, Other: Longevity of rehabilitationsUnirradicular 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. |
| Foraminal enlargement with sodium hypochlorite and photobiomodulation | Experimental | Other: Foraminal Enlargement / Irrigating solutions / Filling materials, Other: Photobiomodulation, Other: OHIP-14, Other: Assessment of pain and edema, Other: Assessment of periapical lesion, Other: Longevity of rehabilitationsUnirradicular 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. |
| Foraminal enlargement with chlorhexidine as irrigant | Experimental | Other: Foraminal Enlargement / Irrigating solutions / Filling materials, Other: OHIP-14, Other: Assessment of pain and edema, Other: Assessment of periapical lesion, Other: Longevity of rehabilitationsUnirradicular 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. |
| Foraminal enlargement with sodium hypochlorite and AH Plus | Active comparator | Other: Foraminal Enlargement / Irrigating solutions / Filling materials, Other: OHIP-14, Other: Assessment of pain and edema, Other: Assessment of periapical lesion, Other: Longevity of rehabilitationsUnirradicular 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. |
| Foraminal enlargement with conventional irrigation | Active comparator | Other: Foraminal Enlargement / Irrigating solutions / Filling materials, Other: OHIP-14, Other: Assessment of pain and edema, Other: Assessment of periapical lesion, Other: Longevity of rehabilitationsMolars 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. |
| Foraminal enlargement with passive ultrasonic irrigation | Experimental | Other: Foraminal Enlargement / Irrigating solutions / Filling materials, Other: Passive ultrasonic irrigation, Other: OHIP-14, Other: Assessment of pain and edema, Other: Assessment of periapical lesion, Other: Longevity of rehabilitationsMolars 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. |
| Foraminal enlargement with cryotherapy | Experimental | Other: Foraminal Enlargement / Irrigating solutions / Filling materials, Other: OHIP-14, Other: Assessment of pain and edema, Other: Assessment of periapical lesion, Other: Longevity of rehabilitations, Other: CryotherapyUnirradicular 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. |
| Foraminal enlargement with cryotherapy and AH Plus | Experimental | Other: Foraminal Enlargement / Irrigating solutions / Filling materials, Other: OHIP-14, Other: Assessment of pain and edema, Other: Assessment of periapical lesion, Other: Longevity of rehabilitations, Other: CryotherapyUnirradicular 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. |
| Foraminal enlargement with ozone therapy | Experimental | Other: Foraminal Enlargement / Irrigating solutions / Filling materials, Other: OHIP-14, Other: Assessment of pain and edema, Other: Assessment of periapical lesion, Other: Longevity of rehabilitations, Other: Ozone therapyUnirradicular 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. |
| Foraminal enlargement with ozone therapy and AH Plus | Experimental | Other: Foraminal Enlargement / Irrigating solutions / Filling materials, Other: OHIP-14, Other: Assessment of pain and edema, Other: Assessment of periapical lesion, Other: Longevity of rehabilitations, Other: Ozone therapyUnirradicular 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy individuals over 18 years of age.
- Unirradicular teeth or molars with necrotic pulps and radiographic evidence of periapical lesion.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foraminal Enlargement / Irrigating solutions / Filling materialsInstrumentation 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. | Other | Foraminal enlargement with chlorhexidine as irrigant, Foraminal enlargement with conventional 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, Foraminal enlargement with passive ultrasonic irrigation, Foraminal enlargement with sodium hypochlorite and AH Plus, Foraminal enlargement with sodium hypochlorite and photobiomodulation, Foraminal enlargement with sodium hypochlorite as irrigant |
| PhotobiomodulationaPDT 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. | Other | Foraminal enlargement with sodium hypochlorite and photobiomodulation |
| Passive ultrasonic irrigationPUI 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. | Other | Foraminal enlargement with passive ultrasonic irrigation |
| OHIP-14Patients will respond a quality of life questionnaire (OHIP-14) on the day of endodontic treatment, on the 7th day and on the 30th day. | Other | Foraminal enlargement with chlorhexidine as irrigant, Foraminal enlargement with conventional 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, Foraminal enlargement with passive ultrasonic irrigation, Foraminal enlargement with sodium hypochlorite and AH Plus, Foraminal enlargement with sodium hypochlorite and photobiomodulation, Foraminal enlargement with sodium hypochlorite as irrigant |
| Assessment of pain and edemaThe 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. | Other | Foraminal enlargement with chlorhexidine as irrigant, Foraminal enlargement with conventional 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, Foraminal enlargement with passive ultrasonic irrigation, Foraminal enlargement with sodium hypochlorite and AH Plus, Foraminal enlargement with sodium hypochlorite and photobiomodulation, Foraminal enlargement with sodium hypochlorite as irrigant |
| Assessment of periapical lesionThe periapical lesion repair will be evaluated clinically and radiographically at 3, 6, 12, 18 and 24 months. | Other | Foraminal enlargement with chlorhexidine as irrigant, Foraminal enlargement with conventional 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, Foraminal enlargement with passive ultrasonic irrigation, Foraminal enlargement with sodium hypochlorite and AH Plus, Foraminal enlargement with sodium hypochlorite and photobiomodulation, Foraminal enlargement with sodium hypochlorite as irrigant |
| Longevity of rehabilitationsThe teeth will be rehabilitated with resin and glass fiber post. The longevity of rehabilitations will be performed clinically and radiographically for 24 months. | Other | Foraminal enlargement with chlorhexidine as irrigant, Foraminal enlargement with conventional 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, Foraminal enlargement with passive ultrasonic irrigation, Foraminal enlargement with sodium hypochlorite and AH Plus, Foraminal enlargement with sodium hypochlorite and photobiomodulation, Foraminal enlargement with sodium hypochlorite as irrigant |
| CryotherapyThe 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. | Other | Foraminal enlargement with cryotherapy, Foraminal enlargement with cryotherapy and AH Plus |
| Ozone therapyThe 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. | Other | Foraminal enlargement with ozone therapy, Foraminal enlargement with ozone therapy and AH Plus |
Primary outcome
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.
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.
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).
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.
To assess edema by photos after foraminal enlargement with photobiomodulation and different irrigating substances (sodium hypochlorite and chlorhexidine) with or without ultrasonic activation.
3 secondary outcomes
Radiografic evaluation of apical repair after endodontic treatment with foraminal enlargement.
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.
Clinical and radiographic evaluation of rehabilations after endodontic treatment with foraminal enlargement.
Time frame: Definitive restorations will be evaluated in adequate; inadequate 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.
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foraminal Enlargement / Irrigating solutions / Filling materials, Photobiomodulation and Passive ultrasonic irrigation in people with Endodontically Treated Teeth and Postoperative Pain, run by Universidade Federal Fluminense at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lívia Antunes, PhD (55-21-987151919, liviaazeredo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.