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Completed

NCT Number: NCT07522918

Single-Session Extraoral PBM After Third Molar Extraction

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.

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Key information

Age range

17 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University Faculty of Dentistry

Konya, Meram, 42090, Turkey (Türkiye)

About this study

This prospective, parallel-group randomized controlled clinical trial was designed to evaluate the effects of a single-session extraoral photobiomodulation (PBM) application on postoperative outcomes following the surgical extraction of impacted mandibular third molars.

The study included 70 patients (age range: 17-25 years) with asymptomatic mesioangular impacted mandibular third molars (Pell-Gregory Class IB). Participants were randomly assigned to either a PBM group (n=35) or a control group (n=35). All surgical procedures were performed by a single surgeon using a standardized technique.

Following the surgery, the PBM group received a single session of extraoral therapy using a dual-wavelength GaAlAs laser (650 nm + 904 nm) for 10 minutes, with a total energy of 270 J. The probe was held in stationary contact over the mandibular angle-ramus region. The control group received no laser application. Postoperative pain was evaluated using a 100-mm Visual Analog Scale (VAS) on days 2 and 7. Secondary outcomes, including facial edema and trismus, were measured at baseline, day 2, and day 7 post-surgery. Additionally, Oral Health-Related Quality of Life (OHRQoL) was assessed using a 100-mm VAS scale at the specified time points.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Postoperative Pain

    Time frame: Postoperative Day 2, and Postoperative Day 7.

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

Secondary outcomes

  1. Postoperative Edema

    Time frame: Preoperatively (baseline), Postoperative Day 2, and Postoperative Day 7.

    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. Total facial distance measured in mm

  2. Trismus

    Time frame: Preoperatively (baseline), Postoperative Day 2, and Postoperative Day 7.

    Assessed by measuring the maximum interincisal distance (MID) between the incisal edges of the maxillary and mandibular central incisors during maximum active mouth opening.Maximum interincisal opening measured in mm using a digital caliper.

  3. Oral Health-Related Quality of Life (OHRQoL)

    Time frame: Postoperative Day 2 and Postoperative Day 7.

    Quality of life was assessed using a 100-mm Visual Analog Scale (VAS), where 0 represents the worst quality of life and 100 represents normal quality of life. Higher scores indicate a better quality of life

Sponsors and collaborators

Lead sponsor

Konya Necmettin Erbakan Üniversitesi

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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