LLLT Effects on Inferior Alveolar Nerve (IAN) Recovery Post-orthognathic Surgery
NCT ID: NCT04910074
Last Updated: 2025-06-24
Study Results
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View full resultsBasic Information
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TERMINATED
NA
25 participants
INTERVENTIONAL
2022-07-01
2024-01-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* intra-operative accidental fracture or rupture of the inferior alveolar nerve
15 Years
ALL
Yes
Sponsors
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Albert Einstein College of Medicine
OTHER
Responsible Party
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Principal Investigators
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Timothy Levine, DMD
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine
Locations
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Jacobi Medical Center, Department of Dentistry and Oral Surgery
The Bronx, New York, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2021-12990
Identifier Type: -
Identifier Source: org_study_id
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