An interventional study of Nd:YAG laser photobiomodulation and Sham laser in Infraorbital Nerve Injury, Inferior Alveolar Nerve Injury and Neurosensory Disturbance Following Orthognathic Surgery, sponsored by National University Hospital, Singapore. Not yet recruiting. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Treatment
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.
Neurosensory disturbances affecting the inferior alveolar nerve (IAN) and infraorbital nerve (ION) are well-recognised expected sequelae of bimaxillary orthognathic surgery, arising from surgical manipulation during sagittal split ramus osteotomy (SSRO) and Le Fort I osteotomy respectively. Published incidence data from a major Asian orthognathic centre [1] reported subjective IAN neurosensory disturbance rates of 35.4% at 6 months and 36.6% at 12 months following mandibular SSRO, and ION disturbance rates of 16.2% at 6 months and 13% at 12 months following Le Fort I osteotomy. These figures represent persistent clinically significant deficits in a substantial proportion of patients at a major Chinese-majority Asian tertiary centre, making them the most directly applicable published proxy for the expected National University Hospital Singapore (NUHS) study population.
Current management of post-orthognathic neurosensory deficits is expectant. In cases of non-recovery beyond six months, pharmacological options or microsurgical repair may be considered, but both carry limited efficacy data and significant procedural risk respectively. There is a clear unmet need for safe, non-invasive adjunctive interventions capable of accelerating neurosensory recovery.
PBM involves the application of low-energy laser irradiation to stimulate mitochondrial cytochrome c oxidase, increasing ATP production, modulating reactive oxygen species, and upregulating neurotrophic factors including nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF). These effects promote axonal regeneration, Schwann cell proliferation, and remyelination. A recent randomised controlled trial [2] comparing Nd:YAG and diode laser PBM versus no-treatment control in 30 post-orthognathic patients reported IAN functional sensory recovery (FSR) rates of 90% in laser-treated groups versus 40% in controls at 12 months (log-rank p=0.001; adjusted hazard ratio 8.04, 95% CI 2.03-31.90). However, that study lacked a sham control, leaving placebo-adjusted efficacy unestablished. The present study addresses this critical gap with a fully sham-controlled, double-blinded design.
Exclusion Criteria:
Photobiomodulation
Device: Nd:YAG laser photobiomodulation
Sham laser
Other: Sham laser
Fotona Laser, Lightwalker, Nightlase
Control
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 frame: 12 months
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.
Time frame: 12 months
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
Time frame: 12 months
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Plan to share: No — Individual participant data will not be shared. The informed consent obtained from participants did not include provisions for sharing individual-level data beyond the research team involved in this study.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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National University Hospital, Singapore