Single-Session Extraoral PBM After Third Molar Extraction

June 8, 2026 updated by: Kubilay Isik, Konya Necmettin Erbakan Üniversitesi

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Postoperative Day 2, and Postoperative Day 7.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Preoperatively (baseline), Postoperative Day 2, and Postoperative Day 7.
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.
Preoperatively (baseline), Postoperative Day 2, and Postoperative Day 7.
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
Postoperative Day 2 and Postoperative Day 7.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Konya Necmettin Erbakan Üniversitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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