Clinical trial NCT04910074: LLLT Effects on Inferior Alveolar Nerve (IAN) Recovery Post-orthognathic Surgery
Official title: LLLT Effects on Inferior Alveolar Nerve (IAN)Recovery Post-orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Mandible; Deformity
Surgical Healing
Orthognathic Surgery
Nerve Injury
Keywords: orthognathic
lllt
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 11
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention vs placebo
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative pain
timeFrame: 24 hours post-surgery
measure: Post-operative pain
timeFrame: 1 week post-surgery
measure: Post-operative pain
timeFrame: 2 weeks post-surgery
measure: Post-operative pain
timeFrame: 3 weeks post-surgery
measure: Post-operative pain
timeFrame: 4 weeks post-surgery
measure: Post-operative pain
timeFrame: 5 weeks post-surgery
measure: Post-operative pain
timeFrame: 6 weeks post-surgery
measure: Post-operative pain
timeFrame: 8 weeks post-surgery
measure: Post-operative pain
timeFrame: 20 weeks post-surgery
measure: Post-operative mandibular swelling
timeFrame: 24 hours post-surgery
measure: Post-operative mandibular swelling
timeFrame: 1 week post-surgery
measure: Post-operative mandibular swelling
timeFrame: 2 weeks post-surgery
measure: Post-operative mandibular swelling
timeFrame: 3 weeks post-surgery
measure: Post-operative mandibular swelling
timeFrame: 4 weeks post-surgery
measure: Post-operative mandibular swelling
timeFrame: 5 weeks post-surgery
measure: Post-operative mandibular swelling
timeFrame: 6 weeks post-surgery
measure: Post-operative mandibular swelling
timeFrame: 8 weeks post-surgery
measure: Post-operative mandibular swelling
timeFrame: 20 weeks post-surgery
measure: Inferior alveolar nerve function for soft stimuli
timeFrame: 24 hours post-surgery
measure: Inferior alveolar nerve function for soft stimuli
timeFrame: 1 week post-surgery
measure: Inferior alveolar nerve function for soft stimuli
timeFrame: 2 weeks post-surgery
measure: Inferior alveolar nerve function for soft stimuli
timeFrame: 3 weeks post-surgery
measure: Inferior alveolar nerve function for soft stimuli
timeFrame: 4 weeks post-surgery
measure: Inferior alveolar nerve function for soft stimuli
timeFrame: 5 weeks post-surgery
measure: Inferior alveolar nerve function for soft stimuli
timeFrame: 6 weeks post-surgery
measure: Inferior alveolar nerve function for soft stimuli
timeFrame: 8 weeks post-surgery
measure: Inferior alveolar nerve function for soft stimuli
timeFrame: 20 weeks post-surgery
measure: Inferior alveolar nerve function for hard stimuli
timeFrame: 24 hours post-surgery
measure: Inferior alveolar nerve function for hard stimuli
timeFrame: 1 week post-surgery
measure: Inferior alveolar nerve function for hard stimuli
timeFrame: 2 weeks post-surgery
measure: Inferior alveolar nerve function for hard stimuli
timeFrame: 3 weeks post-surgery
measure: Inferior alveolar nerve function for hard stimuli
timeFrame: 4 weeks post-surgery
measure: Inferior alveolar nerve function for hard stimuli
timeFrame: 5 weeks post-surgery
measure: Inferior alveolar nerve function for hard stimuli
timeFrame: 6 weeks post-surgery
measure: Inferior alveolar nerve function for hard stimuli
timeFrame: 8 weeks post-surgery
measure: Inferior alveolar nerve function for hard stimuli
timeFrame: 20 weeks post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center, Department of Dentistry and Oral Surgery
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Timothy Levine, DMD
role: PRINCIPAL_INVESTIGATOR
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