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

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

Interventions

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

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.

Sponsors & Collaborators

• Conselho Nacional de Desenvolvimento Científico e Tecnológico

  collaborator OTHER_GOV

• University of Nove de Julho

  lead OTHER

Principal Investigators

• Anna Carolina RT Horliana · University of Nove de Julho

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-10-20

Primary Completion

2024-06-12

Completion

2024-06-13

Countries

• Brazil

Study Locations