Infraorbital Nerve InjuryNCT07789821
Nd:YAG Laser Photobiomodulation for Neurosensory Recovery Following Bimaxillary Orthognathic Surgery
A study testing Nd:YAG laser photobiomodulation in people with Infraorbital Nerve Injury and Inferior Alveolar Nerve Injury, run by National University Hospital, Singapore.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Infraorbital Nerve Injury, Inferior Alveolar Nerve Injury, Neurosensory Disturbance Following Orthognathic Surgery
- What is being tested?
- Nd:YAG laser photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Nd:YAG Laser Photobiomodulation for Neurosensory Recovery Following Bimaxillary Orthognathic Surgery: A Randomised Sham-Controlled Double-Blinded Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Infraorbital Nerve Injury, Inferior Alveolar Nerve Injury, Neurosensory Disturbance Following Orthognathic Surgery, Photobiomodulation
- Being tested
- Nd:YAG laser photobiomodulation, Sham laser
- Keywords
- inferior alveolar nerve injury, photobiomodulation, Neurosensory disturbance following orthognathic surgery, Infraorbital nerve injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd:YAG laser photobiomodulationDevice
Fotona Laser, Lightwalker, Nightlase
Sham laserOther
Control
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation | Experimental | Photobiomodulation Receives: Device: Nd:YAG laser photobiomodulation |
| Control | Sham comparator | Sham laser Receives: Other: Sham laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infraorbital Nerve InjuryStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment model with two arms (active photobiomodulation and sham control) in a 1:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789821
- Sponsor's protocol ID
- NUHdentistry
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 42229538Alolayan AB, Leung YY. Risk factors of neurosensory disturbance following orthognathic surgery. PLoS One. 2014 Mar 5;9(3):e91055. doi: 10.1371/journal.pone.0091055. eCollection 2014.
PubMed 24599321
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nd:YAG Laser Photobiomodulation for Neurosensory Recovery Following Bimaxillary Orthognathic Surgery: A Randomised Sham-Controlled Double-Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT07789821
- Acronym / sponsor ID
- NUHdentistry
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a parallel assignment model with two arms (active photobiomodulation and sham control) in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation | Experimental | Device: Nd:YAG laser photobiomodulationPhotobiomodulation |
| Control | Sham comparator | Other: Sham laserSham laser |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nd:YAG laser photobiomodulationFotona Laser, Lightwalker, Nightlase | Device | Photobiomodulation |
| Sham laserControl | Other | Control |
Primary outcome
Time to functional sensory recovery (FSR) in the inferior alveolar nerve (IAN) distribution
Time frame: 12 months
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.
2 secondary outcomes
Time to functional sensory recovery (FSR) in the infraorbital nerve (ION) distribution
Time frame: 12 months
Oral Health Impact Profile - 14 (OHIP-14)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 42229538Kayim 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.
- Results publication: PubMed 24599321Alolayan AB, Leung YY. Risk factors of neurosensory disturbance following orthognathic surgery. PLoS One. 2014 Mar 5;9(3):e91055. doi: 10.1371/journal.pone.0091055. eCollection 2014.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Nd:YAG laser photobiomodulation in people with Infraorbital Nerve Injury and Inferior Alveolar Nerve Injury, run by National University Hospital, Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chee Weng Yong, BDS, MDS (+65 97872962, dencwy@Nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to functional sensory recovery (FSR) in the inferior alveolar nerve (IAN) distribution (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07789821, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.