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

Albert Einstein College of Medicine

Status: Terminated

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

Treatments: Device: Dummy LLLT; Device: Low-level laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04910074

2021-12990

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

Low-level therapy intervention

Experimental group

Description:

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.

Treatment:

Device: Low-level laser therapy

dummy intervention

Placebo Comparator group

Description:

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.

Treatment:

Device: Dummy LLLT