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

Not Applicable

Suspended

Conditions: Surgical Healing
Orthognathic Surgery
Nerve Injury
Mandible; Deformity

Brief 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

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
dummy intervention	Dummy LLLT	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.
Low-level therapy intervention	Low-level laser therapy	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.

Primary Outcome Measures

Name	Time	Method
Post-operative pain	20 weeks post-surgery	Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible
Post-operative mandibular swelling	20 weeks post-surgery	A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally.
Inferior alveolar nerve function for soft stimuli	20 weeks post-surgery	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.
Inferior alveolar nerve function for hard stimuli	20 weeks post-surgery	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.

Secondary Outcome Measures

Name	Time	Method

Locations (1): Jacobi Medical Center, Department of Dentistry and Oral Surgery
🇺🇸
Bronx, New York, United States

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