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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBM | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. Total facial distance measured in mm | Preoperatively (baseline), Postoperative Day 2, and Postoperative Day 7. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Necmettin Erbakan University Faculty of Dentistry | Konya | Meram | 42090 | Turkey (Türkiye) |
Individual participant data will not be shared to protect patient privacy and in accordance with the institutional data protection policy.
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Potential participants were screened based on clinical and radiographic criteria (mesioangular impacted mandibular third molars, Pell-Gregory Class IB). A total of 70 eligible patients were randomized into two equal groups.
Participants were recruited from the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Necmettin Erbakan University, between February 2025 and January 2026.
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| ID | Title | Description |
|---|---|---|
| FG000 | PBM Group | Participants received a single 10-minute session of extraoral dual-wavelength photobiomodulation (650 nm + 904 nm, 270 J) applied immediately after the surgical extraction. |
| FG001 | Control Group | Participants underwent standardized surgical extraction and received a standard postoperative medication regimen without photobiomodulation therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PBM Group | Participants received a single 10-minute session of extraoral dual-wavelength photobiomodulation (650 nm + 904 nm, 270 J) applied immediately after the surgical extraction. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Pain | Postoperative pain assessed using a 100-mm visual analog scale (VAS; 0 = no pain, 100 = worst imaginable pain) | Posted | Mean | Standard Deviation | mm (0-100 VAS) | Postoperative Day 2, and Postoperative Day 7. |
|
7 days postoperative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PBM Group | Participants received a single 10-minute session of extraoral dual-wavelength photobiomodulation (650 nm + 904 nm, 270 J) applied immediately after the surgical extraction. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Zeynep Asude Bozkır | Necmettin Erbakan University, Faculty of Dentistry | (+90) 507 4289818 | zeynepasudebozkir@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2025 | May 12, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004487 | Edema |
| D014313 | Trismus |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013035 | Spasm |
| D020879 | Neuromuscular Manifestations |
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| 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. |
| 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 | Postoperative Day 2 and Postoperative Day 7. |
Participants underwent standardized surgical extraction and received a standard postoperative medication regimen without photobiomodulation therapy.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | mm | Preoperatively (baseline), Postoperative Day 2, and Postoperative Day 7. |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | Preoperatively (baseline), Postoperative Day 2, and Postoperative Day 7. |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale (0-100) | Postoperative Day 2 and Postoperative Day 7. |
|
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Control Group | Participants underwent standardized surgical extraction and received a standard postoperative medication regimen without photobiomodulation therapy. | 0 | 35 | 0 | 35 | 0 | 35 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| Postoperative Day 7 |
|
| Postoperative Day 7 |
|