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

University of Nove de Julho

Status: Completed

Conditions: Endodontically Treated Teeth; Pain, Postoperative

Treatments: Procedure: Endodontic Treatment; Device: Low Level Laser Therapy; Device: Simulation Low Level Laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06253767

5991.5622.3.0000.5511

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups

Treatment Group (TG)

Experimental group

Description:

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

Treatment:

Device: Low Level Laser Therapy

Procedure: Endodontic Treatment

Control Group (CG)

Sham Comparator group

Description:

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.

Treatment:

Device: Simulation Low Level Laser therapy

Procedure: Endodontic Treatment