Impacted Mandibular Third MolarNCT07522918
Single-Session Extraoral PBM After Third Molar Extraction
A study testing Dual-wavelength GaAlAs laser (650+904 nm) in people with Impacted Mandibular Third Molar and Edema, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 25 years
- Conditions the study is for
- Impacted Mandibular Third Molar, Edema, Trismus
- What is being tested?
- Dual-wavelength GaAlAs laser (650+904 nm)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2025to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University Faculty of Dentistry
Konya, Meram, 42090
About this study
Official title: 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.
Read the 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.
- Conditions
- Impacted Mandibular Third Molar, Edema, Trismus, Postoperative Pain
- Being tested
- Dual-wavelength GaAlAs laser (650+904 nm)
- Keywords
- Photobiomodulation, Low-Level Laser Therapy, Third Molar Surgery, Quality of Life, Randomized Controlled Trial
- Medical subject headings
- Edema, Trismus, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| PBM | Experimental | Participants received a single 10-minute session of extraoral dual-wavelength photobiomodulation (650+904 nm) immediately following the surgical extraction. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Postoperative pain assessed using a 100-mm visual analog scale (VAS; 0 = no pain, 100 = worst imaginable pain)
Measured: Postoperative Day 2, and Postoperative Day 7.
Secondary outcomes (3)
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. Total facial distance measured in mm
Measured: 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.Maximum interincisal opening measured in mm using a digital caliper.
Measured: Preoperatively (baseline), Postoperative Day 2, and Postoperative Day 7.
Oral Health-Related Quality of Life (OHRQoL)
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
Measured: Postoperative Day 2 and Postoperative Day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start15 Feb 2025
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Impacted Mandibular Third MolarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubilay Isik, Konya Necmettin Erbakan Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522918
- Sponsor's protocol ID
- 2025/535
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient privacy and in accordance with the institutional data protection policy.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Session Extraoral Photobiomodulation Reduces Early Postoperative Pain But Not Edema or Trismus After Impacted Mandibular Third Molar Extraction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07522918
- Acronym / sponsor ID
- 2025/535
- Conditions
- Impacted Mandibular Third Molar, Edema, Trismus, Postoperative Pain
- Keywords
- Photobiomodulation, Low-Level Laser Therapy, Third Molar Surgery, Quality of Life, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Posted 9 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBM | Experimental | Device: Dual-wavelength GaAlAs laser (650+904 nm)Participants received a single 10-minute session of extraoral dual-wavelength photobiomodulation (650+904 nm) immediately following the surgical extraction. |
| Control Group | No intervention | –Participants underwent the same standardized surgical extraction protocol but received no additional photobiomodulation therapy. |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | PBM |
Primary outcome
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)
3 secondary outcomes
Postoperative Edema
Time frame: Preoperatively (baseline), Postoperative Day 2, and Postoperative Day 7.
Trismus
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient privacy and in accordance with the institutional data protection policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-wavelength GaAlAs laser (650+904 nm) in people with Impacted Mandibular Third Molar and Edema, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: Postoperative Day 2, and Postoperative Day 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.