LLLT Effects on Inferior Alveolar Nerve (IAN) Recovery Post-orthognathic Surgery

Low-level laser therapy (LLLT) is a well-studied technique that has been shown to improve recovery time and reduce pain and swelling in patients undergoing surgery, including orthognathic surgery, and has no known negative effects. This study will use two groups with patients randomly assigned to either the study group, receiving LLLT, or one receiving a placebo treatment, after they have lower jaw surgery. Measurements will be taken at 24 hours, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 week post-op exams to check pain, swelling and nerve function, and the two groups will be compared to see if the LLLT group has any difference

Study Overview

• Status: Terminated
• Conditions: Mandible; Deformity; Surgical Healing; Orthognathic Surgery; Nerve Injury
• Intervention / Treatment: Device: Low-level laser therapy; Device: Dummy LLLT

Detailed Description

Low-level laser therapy (LLLT) is a well-studied technique to induce biomodulation of pain and wound healing. The technique has been shown to improve recovery time and reduce pain and swelling in patients undergoing surgery, including orthognathic surgery, and has no known negative effects. Previous studies have used split-mouth designs, short follow-up periods or, often, both. This study aims to have two groups, one receiving LLLT and one receiving a dummy treatment, at 24 hours, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 week post-op exams. At each visit, pain (via VAS), swelling (measured from the midpoint of the chin to the base of the ear, bilaterally), and nerve function (using a soft and hard sensory test, in 8 regions of the mandible and lower lip) will be performed, with additional measurements at 8 weeks and 20 weeks. The measurements will be analyzed for statistical differences between the LLLT intervention group and non-intervention group.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Jacobi Medical Center, Department of Dentistry and Oral Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients undergoing mandibular surgery with bilateral sagittal split osteotomies

Exclusion Criteria:

• patients must be free from pre-operative inferior alveolar neurosensory deficiencies
• intra-operative accidental fracture or rupture of the inferior alveolar nerve

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-level therapy intervention; Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.	Device: Low-level laser therapy; The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
Placebo Comparator: dummy intervention; Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.	Device: Dummy LLLT; The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inferior Alveolar Nerve Function for Soft Stimuli	IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.	24 hours post-surgery
Inferior Alveolar Nerve Function for Soft Stimuli	IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.	1 week post-surgery
Inferior Alveolar Nerve Function for Soft Stimuli	IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.	2 weeks post-surgery
Inferior Alveolar Nerve Function for Soft Stimuli	IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.	3 weeks post-surgery
Inferior Alveolar Nerve Function for Soft Stimuli	IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.	4 weeks post-surgery
Inferior Alveolar Nerve Function for Soft Stimuli	IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.	5 weeks post-surgery
Inferior Alveolar Nerve Function for Soft Stimuli	IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.	6 weeks post-surgery
Inferior Alveolar Nerve Function for Soft Stimuli	IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.	8 weeks post-surgery
Inferior Alveolar Nerve Function for Soft Stimuli	IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.	20 weeks post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli	IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.	24 hours post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli	IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.	1 week post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli	IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.	2 weeks post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli	IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.	3 weeks post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli	IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.	4 weeks post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli	IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.	5 weeks post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli	IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.	6 weeks post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli	IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.	8 weeks post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli	IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.	20 weeks post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pain	Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.	24 hours post-surgery
Post-operative Pain	Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.	1 week post-surgery
Post-operative Pain	Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.	2 weeks post-surgery
Post-operative Pain	Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.	3 weeks post-surgery
Post-operative Pain	Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.	4 weeks post-surgery
Post-operative Pain	Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.	5 weeks post-surgery
Post-operative Pain	Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.	6 weeks post-surgery
Post-operative Pain	Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.	8 weeks post-surgery
Post-operative Pain	Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.	20 weeks post-surgery
Post-operative Mandibular Swelling	Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.	24 hours post-surgery
Post-operative Mandibular Swelling	Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.	1 week post-surgery
Post-operative Mandibular Swelling	Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.	2 weeks post-surgery
Post-operative Mandibular Swelling	Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.	3 weeks post-surgery
Post-operative Mandibular Swelling	Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.	4 weeks post-surgery
Post-operative Mandibular Swelling	Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.	5 weeks post-surgery
Post-operative Mandibular Swelling	Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.	6 weeks post-surgery
Post-operative Mandibular Swelling	Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.	8 weeks post-surgery
Post-operative Mandibular Swelling	Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.	20 weeks post-surgery

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Investigators: Principal Investigator: Timothy Levine, DMD, Albert Einstein College of Medicine

Publications and helpful links

General Publications

• D'Agostino A, Trevisiol L, Gugole F, Bondi V, Nocini PF. Complications of orthognathic surgery: the inferior alveolar nerve. J Craniofac Surg. 2010 Jul;21(4):1189-95. doi: 10.1097/SCS.0b013e3181e1b5ff.
• Haghighat A, Khosrawi S, Tamizifar A, Haghighat M. RETRACTED: Does Low-Level Laser Photobiomodulation Improve Neurosensory Recovery After Orthognathic Surgery? A Clinical Trial With Blink Reflex. J Oral Maxillofac Surg. 2021 Mar;79(3):685-693. doi: 10.1016/j.joms.2020.11.025. Epub 2020 Nov 30.
• Gasperini G, Rodrigues de Siqueira IC, Rezende Costa L. Does low-level laser therapy decrease swelling and pain resulting from orthognathic surgery? Int J Oral Maxillofac Surg. 2014 Jul;43(7):868-73. doi: 10.1016/j.ijom.2014.02.015. Epub 2014 Mar 25.
• Khullar SM, Emami B, Westermark A, Haanaes HR. Effect of low-level laser treatment on neurosensory deficits subsequent to sagittal split ramus osteotomy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 Aug;82(2):132-8. doi: 10.1016/s1079-2104(96)80215-0.
• Firoozi P, Keyhan SO, Kim SG, Fallahi HR. Effectiveness of low-level laser therapy on recovery from neurosensory disturbance after sagittal split ramus osteotomy: a systematic review and meta-analysis. Maxillofac Plast Reconstr Surg. 2020 Dec 17;42(1):41. doi: 10.1186/s40902-020-00285-0.
• Ezzati K, Fekrazad R, Raoufi Z. The Effects of Photobiomodulation Therapy on Post-Surgical Pain. J Lasers Med Sci. 2019 Spring;10(2):79-85. doi: 10.15171/jlms.2019.13. Epub 2019 Feb 25.
• Ozen T, Orhan K, Gorur I, Ozturk A. Efficacy of low level laser therapy on neurosensory recovery after injury to the inferior alveolar nerve. Head Face Med. 2006 Feb 15;2:3. doi: 10.1186/1746-160X-2-3.
• Esteves Pinto Faria P, Temprano A, Piva F, Sant'ana E, Pimenta D. Low-level laser therapy for neurosensory recovery after sagittal ramus osteotomy. Minerva Stomatol. 2020 Jun;69(3):141-147. doi: 10.23736/S0026-4970.20.04289-2. Epub 2020 Mar 16.
• Bittencourt MA, Paranhos LR, Martins-Filho PR. Low-level laser therapy for treatment of neurosensory disorders after orthognathic surgery: A systematic review of randomized clinical trials. Med Oral Patol Oral Cir Bucal. 2017 Nov 1;22(6):780-787. doi: 10.4317/medoral.21968.
• Hamid MA. Low-level Laser Therapy on Postoperative Pain after Mandibular Third Molar Surgery. Ann Maxillofac Surg. 2017 Jul-Dec;7(2):207-216. doi: 10.4103/ams.ams_5_17.
• Boutault F, Diallo R, Marecaux C, Modiga O, Paoli JR, Lauwers F. [Neurosensory disorders and functional impairment after bilateral sagittal split osteotomy: role of the anatomical situation of the alveolar pedicle in 76 patients]. Rev Stomatol Chir Maxillofac. 2007 Jun;108(3):175-82; discussion 182. doi: 10.1016/j.stomax.2006.11.006. Epub 2007 Apr 19. French.
• Al-Bishri A, Barghash Z, Rosenquist J, Sunzel B. Neurosensory disturbance after sagittal split and intraoral vertical ramus osteotomy: as reported in questionnaires and patients' records. Int J Oral Maxillofac Surg. 2005 May;34(3):247-51. doi: 10.1016/j.ijom.2004.06.009.
• Al-Bishri A, Rosenquist J, Sunzel B. On neurosensory disturbance after sagittal split osteotomy. J Oral Maxillofac Surg. 2004 Dec;62(12):1472-6. doi: 10.1016/j.joms.2004.04.021.
• Reddy GK. Photobiological basis and clinical role of low-intensity lasers in biology and medicine. J Clin Laser Med Surg. 2004 Apr;22(2):141-50. doi: 10.1089/104454704774076208.
• Kuroyanagi N, Miyachi H, Ochiai S, Kamiya N, Kanazawa T, Nagao T, Shimozato K. Prediction of neurosensory alterations after sagittal split ramus osteotomy. Int J Oral Maxillofac Surg. 2013 Jul;42(7):814-22. doi: 10.1016/j.ijom.2012.11.016. Epub 2012 Dec 21.
• Baas EM, Horsthuis RB, de Lange J. Subjective alveolar nerve function after bilateral sagittal split osteotomy or distraction osteogenesis of mandible. J Oral Maxillofac Surg. 2012 Apr;70(4):910-8. doi: 10.1016/j.joms.2011.02.107. Epub 2011 Jul 16.
• TRAUNER R, OBWEGESER H. The surgical correction of mandibular prognathism and retrognathia with consideration of genioplasty. II. Operating methods for microgenia and distoclusion. Oral Surg Oral Med Oral Pathol. 1957 Aug;10(8):787-92; contd. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): January 23, 2024
• Study Completion (Actual): January 23, 2024

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: orthognathic; lllt
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 2021-12990

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes