NCT04910074

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mandible; Deformity
• Surgical Healing
• Orthognathic Surgery
• Nerve Injury

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-01-23
• Completion: 2024-01-23
• First posted: 2021-06-02
• Last updated: 2025-06-24
• Results posted: 2025-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study