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The Effect of Timing of Low-Level Laser Therapy Application on Accelerating Nerve Injury Healing After Bilateral Sagittal Split Osteotomy of the Mandible

Comparison of Immediate versus Delayed Low-Level Laser Therapy for Improving Neurosensory Complications Following Bilateral Sagittal Split Osteotomy of the Mandible

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250721066584N1
Enrollment
40
Registered
2025-08-18
Start date
2025-08-21
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurosensory complications following bilateral sagittal split osteotom.

Interventions

Intervention 1: Intervention group 1:Patients who have recently undergone surgery and show some degree of nerve injury. Laser irradiation will be performed using a GaAlAs diode laser (Thor, England) i

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who have recently undergone BSSO alone or in combination with Le Fort osteotomy and present with some degree of nerve injury, or patients with persistent nerve injury lasting three to six months after surgery (neuropraxia or axonotmesis due to BSSO) Orthodontic treatment and extraction of third molars performed at least six months prior to surgery.

Exclusion criteria

Exclusion criteria: Incidence of a "bad split" or severe intraoperative bleeding Evidence of clear nerve injury (neurotmesis) up to complete nerve transection during surgery. Postoperative infection. Presence of systemic diseases that may affect tissue regeneration, healing, or growth (e.g., uncontrolled diabetes mellitus, endocrine disorders, chronic inflammatory conditions), and/or neurological diseases (e.g., multiple sclerosis, peripheral neuropathies, neurodegenerative disorders) History of trauma to the head and neck region History of tumor in the head and neck region Pre-existing neuromuscular disorders before surgery Patients taking photosensitive drugs—either endogenous (tetracycline, griseofulvin, sulfonamides, furocoumarins) or exogenous (retinoic acid or glycolic acid) Use of analgesics, anticonvulsants, or antidepressants Any other intervention performed as treatment Use of medication within 24–48 hours before assessment Unwillingness to continue participation in the study

Design outcomes

Primary

MeasureTime frame
Semmes-Weinstein Monofilament (SWMF) Test: Measures the lightest filament that the patient can perceive in each target area (left and right lower lip and chin). Filaments range from A (0.05 g) to F (300 g). Each filament is applied per site as follows: for filaments weighing 0.008 g to 1 g, the stimulus is applied up to three times; for filaments 1.4 g and above, the stimulus is applied once. The thinnest filament correctly detected by the patient is recorded. Timepoint: Baseline (pre-intervention) and at the 6th and 11th sessions. Method of measurement: Complete Semmes-Weinstein Monofilament (SWMF) Kit (20 pieces).

Secondary

MeasureTime frame
The score that the patient assigns on the Visual Analogue Scale (VAS) for their overall sensation is recorded for four areas: left and right lower lip, and left and right chin skin. Timepoint: At the beginning and end of sessions: first session of the study (Baseline, before the intervention), 6th session, and 11th session. Method of measurement: Using the Visual Analogue Scale (VAS) with five options: (1) I have no sensation, (2) I have almost no sensation, (3) Sensation in this area is reduced, (4) Sensation in this area is almost normal, (5) Sensation in this area is normal.;Improvement of Direction Detection: Using a Von Frey monofilament (10 g), the filament is moved randomly either to the right or to the left in each of the four areas (left and right lower lip, left and right chin). The patient is asked to identify the direction of movement. Correctly identifying the direction in =7 out of 10 trials is considered a positive detection in that specific area. Timepoint: Baseline (pre-intervention) and at the 6th and 11th sessions. Method of measurement: Using a Von Frey monofilament (10 gr).;Two-Point Discrimination Test improvement: The minimum distance at which the patient can distinguish two points is measured and recorded in the four areas (left and right lower lip, left and right chin). Distances tested: 3, 5, 7, 10, 15 mm. Timepoint: Baseline (pre-intervention) and at the 6th and 11th sessions. Method of measurement: Using a dry-point compass opened to the sizes of 3, 5, 7, 10, and 15 mm.;Pinprick (PP) Test Improvement:In each of the four areas (left and right lower lip, and left and right chin), 10 random trials are performed using either a dental probe or a cotton swab. The patient is asked to identify whether the object is sharp or soft in each trial. A correct answer in =7 out of 10 trials is considered a positive detection for that area. Timepoint: Baseline (pre-intervention) and at the 6th and 11th sessions. Method of measurement: dental explorer and

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKiana Mazhari

Mashhad University of Medical Sciences

Kianamazhari2@gmail.com+98 996 099 8280

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026