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

NCT04910074 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-06-24

Study results available
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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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Timothy Levine, DMD · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-01-23
Completion
2024-01-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04910074 on ClinicalTrials.gov