This study investigates whether low-energy laser light therapy applied to the skin (photobiomodulation, PBM) can speed up recovery of sensation in the lower lip, chin, and cheek area following jaw surgery (bimaxillary orthognathic surgery). Numbness and altered sensation in these areas are common and expected side effects of jaw surgery, affecting approximately one third of patients at 12 months without active treatment. There is currently no proven non-invasive treatment to accelerate nerve recovery after jaw surgery.
Eligible participants who develop numbness after jaw surgery will be randomly assigned to receive either active PBM laser treatment or an inactive sham laser treatment (6 sessions over 3 weeks). Neither the participant nor the assessor measuring recovery will know which treatment was received. All participants also receive standard postoperative care.
The study aims to determine whether active PBM significantly reduces the time to functional sensory recovery compared with sham treatment, and to characterise recovery patterns using a standardised multicomponent neurosensory assessment battery over 12 months.
Age 21-80 years and above at time of orthognathic surgery.
Underwent bimaxillary orthognathic surgery (SSRO and Le Fort I osteotomy)
Willing and able to comply with the full 12-month follow-up schedule comprising 12 visits.
Systemic diseases known to impair peripheral nerve regeneration, including diabetes mellitus (any type), peripheral neuropathy of any aetiology, multiple sclerosis, or other demyelinating disorders.
Pregnant women are excluded
Patients with cognitive impairment are excluded
History of hypersensitivity or adverse reaction to laser therapy of any type.
Parallel
Nd:YAG laser photobiomodulation
DeviceFotona Laser, Lightwalker, Nightlase
Sham laser
Other interventionControl
Time to functional sensory recovery (FSR) in the inferior alveolar nerve (IAN) distribution
FSR is defined as simultaneous achievement of all three of: (1) Visual Analogue Scale (VAS) = 10 across lateral IAN territory bilaterally using standardised blunt 21-gauge needle shaft; (2) Semmes-Weinstein monofilament ≤3.61 detectable at lateral IAN test sites bilaterally; and (3) Disk-Criminator static two-point discrimination positive at ≤15 mm at lateral IAN test sites bilaterally. Mandibular central incisor regions excluded due to bilateral innervation. The date of the first assessment at which all three criteria are simultaneously met is recorded as time to FSR.
Time to functional sensory recovery (FSR) in the infraorbital nerve (ION) distribution
FSR is defined as simultaneous achievement of all three of: (1) VAS = 10 across lateral IAN territory bilaterally using standardised blunt 21-gauge needle shaft; (2) Semmes-Weinstein monofilament ≤3.61 detectable at lateral IAN test sites bilaterally; and (3) Disk-Criminator static two-point discrimination positive at ≤15 mm at lateral IAN test sites bilaterally. The date of the first assessment at which all three criteria are simultaneously met is recorded as time to FSR.
Oral Health Impact Profile - 14 (OHIP-14)
Oral Health Impact Profile-14 (OHIP-14) total score (0-56) and domain subscores; higher scores indicate greater oral health impact
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