Single-Session Extraoral PBM After Third Molar Extraction

NCT07522918 | Completed Results

• 1 other identifier: 2025/535
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain, edema, and trismus are frequent complications following impacted mandibular third molar surgery. This randomized controlled trial evaluated the effects of a single-session extraoral dual-wavelength photobiomodulation (PBM) (650+904 nm) applied immediately after extraction. The study aimed to assess the impact of this therapy on postoperative pain, edema, trismus, and quality of life (QoL) on days 2 and 7.

Conditions

Edema; Trismus; Postoperative Pain; Impacted Mandibular Third Molar

Keywords

Photobiomodulation; Low-Level Laser Therapy; Third Molar Surgery; Quality of Life; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  Postoperative pain assessed using a 100-mm visual analog scale (VAS; 0 = no pain, 100 = worst imaginable pain)

  Postoperative Day 2, and Postoperative Day 7.

Secondary Outcomes (3)

• Postoperative Edema

  Preoperatively (baseline), Postoperative Day 2, and Postoperative Day 7.

• Trismus

  Preoperatively (baseline), Postoperative Day 2, and Postoperative Day 7.

• Oral Health-Related Quality of Life (OHRQoL)

  Postoperative Day 2 and Postoperative Day 7.

Study Arms (2)

PBM

EXPERIMENTAL

Participants received a single 10-minute session of extraoral dual-wavelength photobiomodulation (650+904 nm) immediately following the surgical extraction.

Device: Dual-wavelength GaAlAs laser (650+904 nm)

Control Group

NO INTERVENTION

Participants underwent the same standardized surgical extraction protocol but received no additional photobiomodulation therapy.

Interventions

Dual-wavelength GaAlAs laser (650+904 nm) DEVICE

Extraoral PBM (GRR Laser) applied for 10 minutes, delivering a total energy of 270 J (fluence: 2.73 J/cm² and irradiance: 4.54 mW/cm²).

PBM

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Indication for extraction of an impacted mandibular third molar in the mesioangular position.
• Asymptomatic tooth in Pell-Gregory Class IB position.
• Absence of systemic disease (ASA I status).
• Healthy status of the impacted tooth and surrounding tissues.
• Adequate oral hygiene.
• Absence of malignant or premalignant oral lesions.

You may not qualify if:

• Pregnancy or lactation.
• Regular use of non-steroidal anti-inflammatory drugs or antibiotics within the preceding week.
• Presence of a diagnosed psychiatric disorder.
• Active smoking.

Sponsors & Collaborators

• Konya Necmettin Erbakan Üniversitesi: lead

Study Sites (1)

Necmettin Erbakan University Faculty of Dentistry

Konya, Meram, 42090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Edema; Trismus; Pain, Postoperative

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pain

Results Point of Contact

• Title: Dr Zeynep Asude Bozkır
• Organization: Necmettin Erbakan University, Faculty of Dentistry

zeynepasudebozkir@gmail.com

(+90) 507 4289818

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 13, 2026
• Study Start: February 15, 2025
• Primary Completion: January 20, 2026
• Study Completion: January 20, 2026
• Last Updated: June 9, 2026
• Results First Posted: June 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)