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

NCT06253767 | Completed

• 1 other identifier: 5991.5622.3.0000.5511
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Endodontically Treated Teeth

Keywords

photobiomodulation; analgesia

Outcome Measures

Primary Outcomes (5)

• Baseline : Analysis of pain before 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

  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

  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

  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

  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 Outcomes (7)

• Baseline : Analysis of pain upon palpation before treatment

  Immediately before the treatment

• Analysis of Palpation Pain 24 Hours After Treatment

  24 hours after treatment

• Baseline: Analysis of pain upon percussion before treatment

  Immediately before the treatment

• Analysis of Percussion Pain 24 Hours After Treatment

  24 hours after treatment

• Analysis of the Required Analgesic Quantity

  24 hours after treatment

Study Arms (2)

Treatment Group (TG)

EXPERIMENTAL

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; Device: Low Level Laser Therapy

Control Group (CG)

SHAM COMPARATOR

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; Device: Simulation Low Level Laser therapy

Interventions

Endodontic Treatment PROCEDURE

Conventional endodontic treatment will be performed equally on all participants.

Control Group (CG); Treatment Group (TG)

Low Level Laser Therapy DEVICE

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

Treatment Group (TG)

Simulation Low Level Laser therapy DEVICE

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.

Control Group (CG)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Universidade Nove de Julho

São Paulo, São Paulo, 11030-480, Brazil

Location

MeSH Terms

Conditions

Pain, Postoperative; Tooth, Nonvital; Agnosia

Interventions

Endodontics; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dentistry; Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Anna Carolina RT Horliana

  University of Nove de Julho

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 12, 2024
• Study Start: October 20, 2022
• Primary Completion: June 12, 2024
• Study Completion: June 13, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

BR (1)