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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mandible; Deformity, Surgical Healing, Orthognathic Surgery, Nerve Injury

Intervention / Treatment
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* Device: Low-level laser therapy
* Device: Dummy LLLT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: intervention vs placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-level therapy intervention<br>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<br>* 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.<br>|
| Placebo Comparator: dummy intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orthognathic, lllt