Clinical Trials Directory

Trials / Completed

CompletedNCT07522918

Single-Session Extraoral PBM After Third Molar Extraction

Single-Session Extraoral Photobiomodulation Reduces Early Postoperative Pain But Not Edema or Trismus After Impacted Mandibular Third Molar Extraction: A Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
Konya Necmettin Erbakan Üniversitesi · Academic / Other
Sex
All
Age
17 Years – 25 Years
Healthy volunteers
Not accepted

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. The results indicate that PBM effectively reduces early postoperative pain and improves QoL on the second day after surgery, although it does not significantly affect edema or trismus.

Detailed description

This prospective, parallel-group randomized controlled trial was conducted to assess the efficacy of photobiomodulation therapy (PBMT) following the surgical removal of mesioangular impacted mandibular third molars. A total of 70 patients (age range: 17-25 years) were enrolled and randomly allocated to either the PBM group (n=35) or the control group (n=35). The surgical procedure followed a standardized protocol performed by a single surgeon. Following extraction, the PBM group received a single 10-minute session of extraoral PBM using a dual-wavelength (650 nm + 904 nm) GaAlAs laser system. The probe was applied over the mandibular angle-ramus region, delivering a total energy of 270 J. Postoperative evaluations included: Pain and Quality of Life (QoL): Measured using 100-mm Visual Analog Scales (VAS). Edema: Quantified via distances between anatomical reference points. Trismus: Quantified by measuring maximum interincisal distance (MID). Measurements were recorded preoperatively (baseline) and on postoperative days 2 and 7 by a blinded clinical investigator.

Conditions

Interventions

TypeNameDescription
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).

Timeline

Start date
2025-02-15
Primary completion
2026-01-20
Completion
2026-01-20
First posted
2026-04-13
Last updated
2026-04-13

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07522918. Inclusion in this directory is not an endorsement.