An interventional study of Dual-wavelength GaAlAs laser (650+904 nm) in Impacted Mandibular Third Molar, Edema and Trismus, sponsored by Konya Necmettin Erbakan Üniversitesi. Completed at 1 site in Turkey (Türkiye). Open to participants aged 17 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Konya Necmettin Erbakan Üniversitesi · Not applicable, Interventional, and Treatment
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.
566 studies on the registry are indexed under Edema; 95 are open to participants now.
This study's enrollment of 70 is above the median of 52 across 401 interventional studies indexed under Edema.
Browse Edema studies →Konya Necmettin Erbakan Üniversitesi is the lead sponsor of 27 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Participants underwent the same standardized surgical extraction protocol but received no additional photobiomodulation therapy.
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).
Postoperative Pain
Postoperative pain assessed using a 100-mm visual analog scale (VAS; 0 = no pain, 100 = worst imaginable pain)
Time frame: Postoperative Day 2, and Postoperative Day 7.
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
Time frame: 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.
Time frame: 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
Time frame: Postoperative Day 2 and Postoperative Day 7.
Participants were recruited from the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Necmettin Erbakan University, between February 2025 and January 2026.
| Milestone | PBM Group | Control Group |
|---|---|---|
| Started | 35 | 35 |
| Completed | 35 | 35 |
| Not completed | 0 | 0 |
Postoperative pain assessed using a 100-mm visual analog scale (VAS; 0 = no pain, 100 = worst imaginable pain)
| mm (0-100 VAS) | PBM Group | Control Group |
|---|---|---|
| Postoperative Day 2 | 20.34 ± 24.38 | 41.43 ± 25.15 |
| Postoperative Day 7 | 6.74 ± 15.08 | 9.34 ± 11.16 |
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
| mm | PBM Group | Control Group |
|---|---|---|
| Preoperative (Baseline) | 284.00 ± 18.57 | 288.20 ± 20.31 |
| Postoperative Day 2 | 300.89 ± 19.46 | 306.83 ± 20.59 |
| Postoperative Day 7 | 290.40 ± 16.90 | 292.80 ± 20.94 |
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.
| mm | PBM Group | Control Group |
|---|---|---|
| Preoperative (Baseline) | 46.54 ± 5.32 | 45.91 ± 5.10 |
| Postoperative Day 2 | 32.14 ± 6.45 | 28.45 ± 7.12 |
| Postoperative Day 7 | 41.20 ± 5.80 | 39.15 ± 6.25 |
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
| score on a scale (0-100) | PBM Group | Control Group |
|---|---|---|
| Postoperative Day 2 | 69.83 ± 25.87 | 50.51 ± 23.24 |
| Postoperative Day 7 | 92.34 ± 12.93 | 87.89 ± 15.40 |
Collected over 7 days postoperative. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PBM Group | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Control Group | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Age, Continuous(years) | PBM Group | Control Group | Total |
|---|---|---|---|
| Mean | 21.94 ± 2.83 | 22.14 ± 2.4 | 22.04 ± 2.61 |
| Sex: Female, Male(Participants) | PBM Group | Control Group | Total |
|---|---|---|---|
| Female | 22 | 20 | 42 |
| Male | 13 | 15 | 28 |
| Race and Ethnicity Not Collected(Participants) | PBM Group | Control Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data will not be shared to protect patient privacy and in accordance with the institutional data protection policy.
Ran from Feb 2025 to primary completion in Jan 2026, 11 months.
Results were first posted in Jun 2026, 4 months after primary completion.
Of 153 non-industry interventional studies with no phase under Edema, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's 11 months is close to that.
Counting every sponsor, half of 168 studies reached it within 11 months; a quarter within 6 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Konya Necmettin Erbakan Üniversitesi