Single-Session Extraoral PBM After Third Molar Extraction

Single-Session Extraoral Photobiomodulation Reduces Early Postoperative Pain But Not Edema or Trismus After Impacted Mandibular Third Molar Extraction: A Randomized Controlled Trial

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. The results indicate that PBM effectively reduces early postoperative pain and improves QoL on the second day after surgery, although it does not significantly affect edema or trismus.

Study Overview

• Status: Completed
• Conditions: Edema; Postoperative Pain; Trismus; Impacted Mandibular Third Molar
• Intervention / Treatment: Device: Dual-wavelength GaAlAs laser (650+904 nm)

Detailed Description

This prospective, parallel-group randomized controlled trial was conducted to assess the efficacy of photobiomodulation therapy (PBMT) following the surgical removal of mesioangular impacted mandibular third molars. A total of 70 patients (age range: 17-25 years) were enrolled and randomly allocated to either the PBM group (n=35) or the control group (n=35).

The surgical procedure followed a standardized protocol performed by a single surgeon. Following extraction, the PBM group received a single 10-minute session of extraoral PBM using a dual-wavelength (650 nm + 904 nm) GaAlAs laser system. The probe was applied over the mandibular angle-ramus region, delivering a total energy of 270 J.

Postoperative evaluations included:

Pain and Quality of Life (QoL): Measured using 100-mm Visual Analog Scales (VAS).

Edema: Quantified via distances between anatomical reference points.

Trismus: Quantified by measuring maximum interincisal distance (MID).

Measurements were recorded preoperatively (baseline) and on postoperative days 2 and 7 by a blinded clinical investigator.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Meram
    • Konya, Meram, Turkey (Türkiye), 42090
      • Necmettin Erbakan University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PBM; 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); 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).
No Intervention: Control Group; Participants underwent the same standardized surgical extraction protocol but received no additional photobiomodulation therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	Postoperative pain assessed using a 100-mm visual analog scale (VAS; 0 = no pain, 100 = worst imaginable pain)	Baseline, Postoperative Day 2, and Postoperative Day 7.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Edema	Facial edema quantified by the sum of distances between three anatomical reference points: tragus to labial commissure, gonion to lateral canthus, and gonion to labial commissure. Results expressed as percentage increase relative to baseline.	Preoperatively (baseline), Postoperative Day 2, and Postoperative Day 7.
Trismus	Assessed by measuring the maximum interincisal distance (MID) between the incisal edges of the maxillary and mandibular central incisors during maximum active mouth opening.	Preoperatively (baseline), Postoperative Day 2, and Postoperative Day 7.
Oral Health-Related Quality of Life (OHRQoL)	Global assessment of overall well-being and functional tasks using a 100-mm visual analog scale (VAS; 0 = worst possible quality of life, 100 = normal quality of life).	Postoperative Day 2 and Postoperative Day 7.

Collaborators and Investigators

• Sponsor: Konya Necmettin Erbakan Üniversitesi

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2025
• Primary Completion (Actual): January 20, 2026
• Study Completion (Actual): January 20, 2026

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Randomized Controlled Trial; Photobiomodulation; Low-Level Laser Therapy; Third Molar Surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Postoperative Complications; Pathologic Processes; Spasm; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Trismus; Edema
• Other Study ID Numbers: 2025/535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect patient privacy and in accordance with the institutional data protection policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No