Edema, Impacted Mandibular Third Molar, Postoperative Pain, Trismus
Conditions
Keywords
Photobiomodulation, Low-Level Laser Therapy, Third Molar Surgery, Quality of Life, Randomized Controlled Trial
Brief 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. 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.
Interventions
DEVICEDual-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).
Sponsors
Konya Necmettin Erbakan Üniversitesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Edema | 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 |
| Trismus | 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. |
| Oral Health-Related Quality of Life (OHRQoL) | 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 |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Participants were recruited from the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Necmettin Erbakan University, between February 2025 and January 2026.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 22.04 years STANDARD_DEVIATION 2.61 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
None listed