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

Nerve Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04910074
• Other study ID #: 2021-12990
• Status: Suspended
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 11
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Mandible; Deformity
• Nerve Injury
• Orthognathic Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Jacobi Medical Center, Department of Dentistry and Oral Surgery	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible	24 hours post-surgery
Primary	Post-operative pain	Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible	1 week post-surgery
Primary	Post-operative pain	Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible	2 weeks post-surgery
Primary	Post-operative pain	Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible	3 weeks post-surgery
Primary	Post-operative pain	Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible	4 weeks post-surgery
Primary	Post-operative pain	Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible	5 weeks post-surgery
Primary	Post-operative pain	Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible	6 weeks post-surgery
Primary	Post-operative pain	Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible	8 weeks post-surgery
Primary	Post-operative pain	Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible	20 weeks post-surgery
Primary	Post-operative mandibular swelling	A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally.	24 hours post-surgery
Primary	Post-operative mandibular swelling	A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally.	1 week post-surgery
Primary	Post-operative mandibular swelling	A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally.	2 weeks post-surgery
Primary	Post-operative mandibular swelling	A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally.	3 weeks post-surgery
Primary	Post-operative mandibular swelling	A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally.	4 weeks post-surgery
Primary	Post-operative mandibular swelling	A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally.	5 weeks post-surgery
Primary	Post-operative mandibular swelling	A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally.	6 weeks post-surgery
Primary	Post-operative mandibular swelling	A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally.	8 weeks post-surgery
Primary	Post-operative mandibular swelling	A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally.	20 weeks post-surgery
Primary	Inferior alveolar nerve function for soft stimuli	Cotton swab brushed in 2cm path onto skin of 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.	24 hours post-surgery
Primary	Inferior alveolar nerve function for soft stimuli	Cotton swab brushed in 2cm path onto skin of 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.	1 week post-surgery
Primary	Inferior alveolar nerve function for soft stimuli	Cotton swab brushed in 2cm path onto skin of 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.	2 weeks post-surgery
Primary	Inferior alveolar nerve function for soft stimuli	Cotton swab brushed in 2cm path onto skin of 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.	3 weeks post-surgery
Primary	Inferior alveolar nerve function for soft stimuli	Cotton swab brushed in 2cm path onto skin of 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.	4 weeks post-surgery
Primary	Inferior alveolar nerve function for soft stimuli	Cotton swab brushed in 2cm path onto skin of 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.	5 weeks post-surgery
Primary	Inferior alveolar nerve function for soft stimuli	Cotton swab brushed in 2cm path onto skin of 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.	6 weeks post-surgery
Primary	Inferior alveolar nerve function for soft stimuli	Cotton swab brushed in 2cm path onto skin of 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.	8 weeks post-surgery
Primary	Inferior alveolar nerve function for soft stimuli	Cotton swab brushed in 2cm path onto skin of 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.	20 weeks post-surgery
Primary	Inferior alveolar nerve function for hard stimuli	Toothpick pressed into skin of 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.	24 hours post-surgery
Primary	Inferior alveolar nerve function for hard stimuli	Toothpick pressed into skin of 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.	1 week post-surgery
Primary	Inferior alveolar nerve function for hard stimuli	Toothpick pressed into skin of 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.	2 weeks post-surgery
Primary	Inferior alveolar nerve function for hard stimuli	Toothpick pressed into skin of 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.	3 weeks post-surgery
Primary	Inferior alveolar nerve function for hard stimuli	Toothpick pressed into skin of 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.	4 weeks post-surgery
Primary	Inferior alveolar nerve function for hard stimuli	Toothpick pressed into skin of 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.	5 weeks post-surgery
Primary	Inferior alveolar nerve function for hard stimuli	Toothpick pressed into skin of 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.	6 weeks post-surgery
Primary	Inferior alveolar nerve function for hard stimuli	Toothpick pressed into skin of 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.	8 weeks post-surgery
Primary	Inferior alveolar nerve function for hard stimuli	Toothpick pressed into skin of 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.	20 weeks post-surgery