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NCT04910074

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

Terminated NA Results posted Last updated 24 June 2025
What this trial tests

NA trial testing Low-level laser therapy in Mandible; Deformity in 25 participants. Terminated before completion.

Timeline
1 July 2022
Primary endpoint
23 January 2024
23 January 2024

Quick facts

Lead sponsorAlbert Einstein College of Medicine
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment25
Start date1 July 2022
Primary completion23 January 2024
Estimated completion23 January 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Albert Einstein College of Medicine

Who can join

15 and older, any sex, with Mandible; Deformity or Surgical Healing. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Inferior Alveolar Nerve Function for Soft Stimuli Primary · 1 week post-surgery

IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the 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. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized

R1
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention3
R2
GroupValue95% CI
Low-level Therapy Intervention11
Sham Intervention8
R3
GroupValue95% CI
Low-level Therapy Intervention11
Sham Intervention6
R4
GroupValue95% CI
Low-level Therapy Intervention7
Sham Intervention2
L1
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention1
L2
GroupValue95% CI
Low-level Therapy Intervention11
Sham Intervention8
L3
GroupValue95% CI
Low-level Therapy Intervention11
Sham Intervention8
L4
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention2
Inferior Alveolar Nerve Function for Soft Stimuli Primary · 2 weeks post-surgery

IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the 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. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized

R1
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention6
R2
GroupValue95% CI
Low-level Therapy Intervention9
Sham Intervention9
R3
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention9
R4
GroupValue95% CI
Low-level Therapy Intervention7
Sham Intervention5
L1
GroupValue95% CI
Low-level Therapy Intervention7
Sham Intervention4
L2
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention9
L3
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention9
L4
GroupValue95% CI
Low-level Therapy Intervention6
Sham Intervention3
Inferior Alveolar Nerve Function for Soft Stimuli Primary · 3 weeks post-surgery

IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the 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. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized

R1
GroupValue95% CI
Low-level Therapy Intervention7
Sham Intervention5
R2
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention8
R3
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention8
R4
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention6
L1
GroupValue95% CI
Low-level Therapy Intervention7
Sham Intervention3
L2
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention7
L3
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention7
L4
GroupValue95% CI
Low-level Therapy Intervention7
Sham Intervention4
Inferior Alveolar Nerve Function for Soft Stimuli Primary · 4 weeks post-surgery

IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the 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. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized

R1
GroupValue95% CI
Low-level Therapy Intervention5
Sham Intervention6
R2
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention9
R3
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention9
R4
GroupValue95% CI
Low-level Therapy Intervention7
Sham Intervention7
L1
GroupValue95% CI
Low-level Therapy Intervention4
Sham Intervention6
L2
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention9
L3
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention9
L4
GroupValue95% CI
Low-level Therapy Intervention5
Sham Intervention5
Inferior Alveolar Nerve Function for Soft Stimuli Primary · 5 weeks post-surgery

IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the 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. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized

R1
GroupValue95% CI
Low-level Therapy Intervention6
Sham Intervention3
R2
GroupValue95% CI
Low-level Therapy Intervention6
Sham Intervention6
R3
GroupValue95% CI
Low-level Therapy Intervention6
Sham Intervention6
R4
GroupValue95% CI
Low-level Therapy Intervention6
Sham Intervention4
L1
GroupValue95% CI
Low-level Therapy Intervention3
Sham Intervention4
L2
GroupValue95% CI
Low-level Therapy Intervention6
Sham Intervention6
L3
GroupValue95% CI
Low-level Therapy Intervention6
Sham Intervention6
L4
GroupValue95% CI
Low-level Therapy Intervention3
Sham Intervention4
Inferior Alveolar Nerve Function for Soft Stimuli Primary · 6 weeks post-surgery

IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the 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. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized

R1
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention6
R2
GroupValue95% CI
Low-level Therapy Intervention9
Sham Intervention8
R3
GroupValue95% CI
Low-level Therapy Intervention9
Sham Intervention8
R4
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention6
L1
GroupValue95% CI
Low-level Therapy Intervention5
Sham Intervention6
L2
GroupValue95% CI
Low-level Therapy Intervention9
Sham Intervention8
L3
GroupValue95% CI
Low-level Therapy Intervention9
Sham Intervention7
L4
GroupValue95% CI
Low-level Therapy Intervention5
Sham Intervention6
Inferior Alveolar Nerve Function for Soft Stimuli Primary · 8 weeks post-surgery

IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the 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. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized

R1
GroupValue95% CI
Low-level Therapy Intervention2
Sham Intervention4
R2
GroupValue95% CI
Low-level Therapy Intervention4
Sham Intervention5
R3
GroupValue95% CI
Low-level Therapy Intervention4
Sham Intervention5
R4
GroupValue95% CI
Low-level Therapy Intervention2
Sham Intervention4
L1
GroupValue95% CI
Low-level Therapy Intervention3
Sham Intervention3
L2
GroupValue95% CI
Low-level Therapy Intervention4
Sham Intervention5
L3
GroupValue95% CI
Low-level Therapy Intervention4
Sham Intervention5
L4
GroupValue95% CI
Low-level Therapy Intervention2
Sham Intervention4
Inferior Alveolar Nerve Function for Hard Stimuli Primary · 1 week post-surgery

IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study

R1
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention2
R2
GroupValue95% CI
Low-level Therapy Intervention11
Sham Intervention8
R3
GroupValue95% CI
Low-level Therapy Intervention11
Sham Intervention8
R4
GroupValue95% CI
Low-level Therapy Intervention7
Sham Intervention2
L1
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention0
L2
GroupValue95% CI
Low-level Therapy Intervention11
Sham Intervention6
L3
GroupValue95% CI
Low-level Therapy Intervention11
Sham Intervention8
L4
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention4
Inferior Alveolar Nerve Function for Hard Stimuli Primary · 2 weeks post-surgery

IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study

R1
GroupValue95% CI
Low-level Therapy Intervention6
Sham Intervention5
R2
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention9
R3
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention9
R4
GroupValue95% CI
Low-level Therapy Intervention7
Sham Intervention5
L1
GroupValue95% CI
Low-level Therapy Intervention6
Sham Intervention5
L2
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention8
L3
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention9
L4
GroupValue95% CI
Low-level Therapy Intervention5
Sham Intervention5
Inferior Alveolar Nerve Function for Hard Stimuli Primary · 3 weeks post-surgery

IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study

R1
GroupValue95% CI
Low-level Therapy Intervention9
Sham Intervention6
R2
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention8
R3
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention8
R4
GroupValue95% CI
Low-level Therapy Intervention9
Sham Intervention6
L1
GroupValue95% CI
Low-level Therapy Intervention9
Sham Intervention4
L2
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention8
L3
GroupValue95% CI
Low-level Therapy Intervention10
Sham Intervention8
L4
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention5
Inferior Alveolar Nerve Function for Hard Stimuli Primary · 4 weeks post-surgery

IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study

R1
GroupValue95% CI
Low-level Therapy Intervention5
Sham Intervention7
R2
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention9
R3
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention9
R4
GroupValue95% CI
Low-level Therapy Intervention7
Sham Intervention8
L1
GroupValue95% CI
Low-level Therapy Intervention4
Sham Intervention6
L2
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention9
L3
GroupValue95% CI
Low-level Therapy Intervention8
Sham Intervention9
L4
GroupValue95% CI
Low-level Therapy Intervention5
Sham Intervention5
Inferior Alveolar Nerve Function for Hard Stimuli Primary · 5 weeks post-surgery

IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study

R1
GroupValue95% CI
Low-level Therapy Intervention6
Sham Intervention3
R2
GroupValue95% CI
Low-level Therapy Intervention6
Sham Intervention6
R3
GroupValue95% CI
Low-level Therapy Intervention6
Sham Intervention6
R4
GroupValue95% CI
Low-level Therapy Intervention5
Sham Intervention3
L1
GroupValue95% CI
Low-level Therapy Intervention3
Sham Intervention4
L2
GroupValue95% CI
Low-level Therapy Intervention6
Sham Intervention6
L3
GroupValue95% CI
Low-level Therapy Intervention6
Sham Intervention6
L4
GroupValue95% CI
Low-level Therapy Intervention3
Sham Intervention3

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Low-level laser therapy

Trials testing the same drug.

Other recruiting trials for Mandible; Deformity

Currently open trials in the same condition.

Other Albert Einstein College of Medicine trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing