Post-Endodontic Instrumentation Pain After in a Single Session Associated With Photobiomodulation

October 8, 2024 updated by: Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho

Analysis of Post-Endodontic Instrumentation Pain in Molars and Premolars Treated in a Single Session Associated With Photobiomodulation: A Double-blind Randomized Clinical Study

The objective of this double-blind, randomized controlled clinical study will be to evaluate the effect f PBM on pain after endodontic instrumentation in the single-session treatment of upper molars and premolars. The sample will consist of 58 participants treated endodontically in a single session and randomly allocated to the PBM Group with conventional treatment with photobiomodulation and the Control Group with conventional treatment with simulation of PBM. The primary variable of the study will be the evaluation of spontaneous pain immediately before treatment, and the participant will be reassessed for postoperative pain 24 hours after instrumentation using the visual analog scale (VAS). As secondary variables, pain prevalence, pain at 4h, 8h, and 12h after the procedure, palpation pain (vestibular and lingual), and percussion pain (vertical and horizontal) will be assessed 24 hours after the procedure, as well as the number of necessary analgesics (paracetamol) and the impact of oral health on quality of life evaluated by the OHIP 14 instrument.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The randomized clinical trials conducted in recent years have demonstrated that photobiomodulation (PBM) modulates postoperative pain in endodontic instrumentation, especially in the first days after the procedure. Although the results are promising, there is still low-quality evidence regarding the best dosimetric parameter applied. The objective of this double-blind, randomized controlled clinical study will be to evaluate the effect of PBM on pain after endodontic instrumentation in the single-session treatment of upper molars and premolars. The sample will consist of 58 participants treated endodontically in a single session and randomly allocated to the PBM Group (n=29): conventional treatment with photobiomodulation (808 nm, 100mW power, 3J per point, 3mm2 area, 3 points in the region of the root apices - two vestibular and one palatal, total energy of 9J - for molars and premolars 2 points - 1 vestibular and another palatal, total energy of 6J) and Control Group (n=29): conventional treatment with simulation of PBM. The primary variable of the study will be the evaluation of spontaneous pain immediately before treatment, and the participant will be reassessed for postoperative pain 24 hours after instrumentation using the visual analog scale (VAS). As secondary variables, pain prevalence, pain at 4h, 8h, and 12h after the procedure, palpation pain (vestibular and lingual), and percussion pain (vertical and horizontal) will be assessed 24 hours after the procedure, as well as the number of necessary analgesics (paracetamol) and the impact of oral health on quality of life evaluated by the OHIP 14 instrument.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 11030-480
        • Universidade Nove de Julho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with endodontic involvement in three-rooted (upper molars) or two-rooted (upper premolars) teeth.
  • Age between 20 and 75 years.
  • Both genders.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Patients with oncological, renal, or Type I or Type II diabetes.
  • Drug users; alcohol or tobacco users.
  • Immunocompromised patients or those using immunosuppressive medication.
  • Use of alendronate, bisphosphonates, or any systemic medication that interferes with bone metabolism.
  • Presence of associated periodontal disease.
  • Frequent exacerbations.
  • Radiolucency images with PAI stages 3, 4, or 5 (Orstavik et al., 1986).
  • Any other anatomical variation that renders single-session endodontic treatment unfeasible.
  • Teeth with previous endodontic treatment.
  • Patients with asymptomatic non-microbial apical periodontitis with any type of bruxism (clenching) or using a bite splint.
  • Teeth with more than ⅔ coronal involvement, making proper use of rubber dam isolation impossible.
  • Use of antibiotics in the last three months.
  • History of severe allergy to chlorine or its derivatives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group (TG)
They are composed of 29 participants. After endodontic treatment, they will receive PBM for molars with 808nm application (AsGaAl), infrared, equipment with a power of 100 mW, and an exit beam area of 1 cm² perpendicular in contact with the mucosa at the level of the root apices at two vestibular points and one complementary palatal point, with 3J of energy per point (30s per point), totaling 9J of total delivered energy and 90 seconds of application time. The Radiant Exposure is 3J/cm² per point, totaling 9J/cm² overall. To premolars the parameters will be 808nm application (AsGaAl), infrared, Laser Duo® equipment with a power of 100 mW and an exit beam area of 1cm² perpendicular in contact with the mucosa at the level of the root apices at one vestibular point and one complementary palatal point, with 3J of energy per point (30s per point), totaling 6J of total delivered energy and 60 seconds of application time. The Radiant Exposure is 3J/cm² per point, totaling 6J/cm² overall
Procedure: Endodontic Treatment
Conventional endodontic treatment will be performed equally on all participants.
Device: Low Level Laser Therapy
Treatment Group (TG) will receive photobiomodulation for molars with 808nm application (AsGaAl), infrared, equipment with a power of 100 mW, and an exit beam area of 1 cm² perpendicular in contact with the mucosa at the level of the root apices at two vestibular points and one complementary palatal point, with 3J of energy per point (30s per point), totaling 9J of total delivered energy and 90 seconds of application time. The Radiant Exposure is 3J/cm² per point, totaling 9J/cm² overall. To premolars the parameters will be 808nm application (AsGaAl), infrared, Laser Duo® equipment with a power of 100 mW and an exit beam area of 1cm² perpendicular in contact with the mucosa at the level of the root apices at one vestibular point and one complementary palatal point, with 3J of energy per point (30s per point), totaling 6J of total delivered energy and 60 seconds of application time. The Radiant Exposure is 3J/cm² per point, totaling 6J/cm² overall
Sham Comparator: Control Group (CG)
They are composed of 29 participants. After endodontic treatment, they will receive a simulation of the PBM session with all individual preparation involved, such as individual protection with goggles, and the sounds of the equipment (Laser Duo®, MMOptics, São Carlos, SP) will be recorded and played at the time of the session, but the equipment will not be activated.
Procedure: Endodontic Treatment
Conventional endodontic treatment will be performed equally on all participants.
Device: Simulation Low Level Laser therapy
A simulation of low-level laser therapy was performed on the control group starting from patient preparation (placement of glasses) and the reproduction of device sounds without activation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Baseline : Analysis of pain before treatment
Time Frame: Immediately before the treatment
Before the treatment, regardless of the patient's randomized group, pain assessment will be conducted on the tooth and the surrounding area through palpation and percussion exams. Therefore, the patient will mark on the visual pain scale corresponding to their immediate pain, pain upon palpation, and pain upon percussion just before the treatment. The researcher will measure, using a ruler, the distance from "0" (no pain) to the patient's marked point, and this value will be taken as the comparator.
Immediately before the treatment
Analysis of Postoperative Pain at 4 Hours After Treatment
Time Frame: 4 hours after treatment
After root canal obturation, all participants will receive a sheet containing a visual pain scale to document postoperative pain at 4 hours after the procedure. This scale will be exactly 10 cm and will range from 0 to 10, where the participant must mark a level representing their pain at that moment. This mark will be measured with a ruler, and the corresponding level will be noted.
4 hours after treatment
Analysis of Postoperative Pain at 8 Hours After Treatment
Time Frame: 8 hours after treatment
After root canal obturation, all participants will receive a sheet containing a visual pain scale to document postoperative pain at 8 hours after the procedure. This scale will be exactly 10 centimeters and will range from 0 to 10, where the participant must mark a level representing their pain at that moment. This mark will be measured with a ruler, and the corresponding level will be noted.
8 hours after treatment
Analysis of Postoperative Pain at 12 Hours After Treatment
Time Frame: 12 hours after treatment
After root canal obturation, all participants will receive a sheet containing a visual pain scale to document postoperative pain at 12 hours after the procedure. This scale will be exactly 10 centimeters and will range from 0 to 10, where the participant must mark a level representing their pain at that moment. This mark will be measured with a ruler, and the corresponding level will be noted.
12 hours after treatment
Analysis of Postoperative Pain at 24 Hours After Treatment
Time Frame: 24 hours after treatment
24 hours after the root canal filling, whether or not accompanied by photobiomodulation, the patient will return to the clinic for a reassessment of immediate pain. At this moment, the patient will be provided with a visual analog scale consisting of exactly 10 centimeters, with markings of "0" (no pain) and "10" representing maximum pain. The patient will then make a mark on this scale to indicate their current level of pain in the dental element. After the marking, the researcher will measure the distance from zero to the marked point using a millimeter ruler, and the obtained result will be recorded and statistically compared with the preoperative pain.
24 hours after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Baseline : Analysis of pain upon palpation before treatment
Time Frame: Immediately before the treatment
Before the treatment, regardless of the patient's randomized group, pain assessment will be conducted on the tooth and the surrounding area through palpation and percussion exams. Therefore, the patient will mark on the visual pain scale corresponding to their immediate pain, pain upon palpation, and pain upon percussion just before the treatment. The researcher will measure, using a ruler, the distance from "0" (no pain) to the patient's marked point, and this value will be taken as the comparator.
Immediately before the treatment
Analysis of Palpation Pain 24 Hours After Treatment
Time Frame: 24 hours after treatment
During the same follow-up appointment 24 hours after endodontic treatment, palpation pain (vestibular and palatal) will be analyzed. The participant, after palpating the vestibular board, will mark on the visual pain scale the level of referred pain, and the same procedure will be done after palpating the palatal bony board.
24 hours after treatment
Baseline: Analysis of pain upon percussion before treatment
Time Frame: Immediately before the treatment
Before the treatment, regardless of the patient's randomized group, pain assessment will be conducted on the tooth and the surrounding area through palpation and percussion exams. Therefore, the patient will mark on the visual pain scale corresponding to their immediate pain, pain upon palpation, and pain upon percussion just before the treatment. The researcher will measure, using a ruler, the distance from "0" (no pain) to the patient's marked point, and this value will be taken as the comparator.
Immediately before the treatment
Analysis of Percussion Pain 24 Hours After Treatment
Time Frame: 24 hours after treatment
Percussion pain (vertical and horizontal) will also be assessed 24 hours after treatment. These assessments will be performed by the principal investigator, who is blinded to the treatment administered and properly calibrated.
24 hours after treatment
Analysis of the Required Analgesic Quantity
Time Frame: 24 hours after treatment
Following the completion of endodontic treatment, all participants will be provided with 750mg Paracetamol tablets, and they will be instructed to take them in case of extreme pain. The quantity of analgesic intake should be noted on the sheet provided for recording pain experiences and returned during the 24-hour follow-up appointment.
24 hours after treatment
Oral Health Impact Profile-14
Time Frame: 24 hours after treatment
The effects of treatment on participants' quality of life will be assessed using the patient-centered outcome measures from the Oral Health Impact Profile-14 (OHIP-14). The questionnaire will be handed to participants at the end of the treatment, and they will be properly instructed to fill it out and return it during the 24-hour follow-up.
24 hours after treatment
Prevalence Analysis
Time Frame: 24 hours after treatment
In the prevalence analysis of a particular condition, the frequency of occurrence of the condition, or in this case, the painful condition, in a specific population at a single point in time or a short period will be obtained (Bonita et al., 1993). In this study, the prevalence of pain before and 24 hours after endodontic instrumentation in the single-session treatment of upper molars will be examined.
24 hours after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nove de Julho

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Anna Carolina RT Horliana, University of Nove de Julho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5991.5622.3.0000.5511

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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