Nd:YAG Laser Photobiomodulation for Neurosensory Recovery Following Bimaxillary Orthognathic Surgery
NCT07789821 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2026-08-27
Summary
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.
Conditions
- Infraorbital Nerve Injury
- Inferior Alveolar Nerve Injury
- Neurosensory Disturbance Following Orthognathic Surgery
- Photobiomodulation
Interventions
- DEVICE
-
Nd:YAG laser photobiomodulation
Fotona Laser, Lightwalker, Nightlase
- OTHER
-
Sham laser
Control
Sponsors & Collaborators
-
National University Hospital, Singapore
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-01
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
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