Nd:YAG Laser Photobiomodulation for Neurosensory Recovery Following Bimaxillary Orthognathic Surgery

NCT07789821 | Not Yet Recruiting

• 1 other identifier: NUHdentistry
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

inferior alveolar nerve injury; photobiomodulation; Neurosensory disturbance following orthognathic surgery; Infraorbital nerve injury

Outcome Measures

Primary Outcomes (1)

• Time to functional sensory recovery (FSR) in the inferior alveolar nerve (IAN) distribution

  FSR is defined as simultaneous achievement of all three of: (1) VAS = 0 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.

  12 months

Secondary Outcomes (2)

• Time to functional sensory recovery (FSR) in the infraorbital nerve (ION) distribution

  12 months

• OHIP-14

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Photobiomodulation

Device: Nd:YAG laser photobiomodulation

Control

SHAM COMPARATOR

Sham laser

Other: Sham laser

Interventions

Nd:YAG laser photobiomodulation DEVICE

Fotona Laser, Lightwalker, Nightlase

Intervention

Sham laser OTHER

Control

Control

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-80 years and above at time of orthognathic surgery.
• Underwent bimaxillary orthognathic surgery (SSRO and Le Fort I osteotomy), without genioplasty
• Willing and able to comply with the full 12-month follow-up schedule comprising 12 visits.

You may not qualify if:

• 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.
• Surgical complication directly attributable to the orthognathic procedure that required reoperation or microsurgical nerve repair, as these represent a fundamentally different injury severity and recovery trajectory from the neurapraxic and axonotmetic injuries targeted by this study.
• Genioplasty performed

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Related Publications (1)

• Kayim YT, Ozkan N, Akbulut N, Kirtiloglu T. Nd:YAG and Diode Laser Biostimulation in Infraorbital and Inferior Alveolar Neurosensory Recovery After Orthognathic Surgery: A Randomized Clinical Study. J Oral Maxillofac Surg. 2026 May 20:S0278-2391(26)00402-7. doi: 10.1016/j.joms.2026.05.062. Online ahead of print.

  PMID: 42229538 BACKGROUND

Central Study Contacts

Chee Weng Yong, BDS, MDS

CONTACT

+65 97872962; dencwy@Nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Biostatistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a parallel assignment model with two arms (active photobiomodulation and sham control) in a 1:1 ratio.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08