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 StimuliPrimary· 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
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
3
R2
Group
Value
95% CI
Low-level Therapy Intervention
11
Sham Intervention
8
R3
Group
Value
95% CI
Low-level Therapy Intervention
11
Sham Intervention
6
R4
Group
Value
95% CI
Low-level Therapy Intervention
7
Sham Intervention
2
L1
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
1
L2
Group
Value
95% CI
Low-level Therapy Intervention
11
Sham Intervention
8
L3
Group
Value
95% CI
Low-level Therapy Intervention
11
Sham Intervention
8
L4
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
2
Inferior Alveolar Nerve Function for Soft StimuliPrimary· 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
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
6
R2
Group
Value
95% CI
Low-level Therapy Intervention
9
Sham Intervention
9
R3
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
9
R4
Group
Value
95% CI
Low-level Therapy Intervention
7
Sham Intervention
5
L1
Group
Value
95% CI
Low-level Therapy Intervention
7
Sham Intervention
4
L2
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
9
L3
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
9
L4
Group
Value
95% CI
Low-level Therapy Intervention
6
Sham Intervention
3
Inferior Alveolar Nerve Function for Soft StimuliPrimary· 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
Group
Value
95% CI
Low-level Therapy Intervention
7
Sham Intervention
5
R2
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
8
R3
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
8
R4
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
6
L1
Group
Value
95% CI
Low-level Therapy Intervention
7
Sham Intervention
3
L2
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
7
L3
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
7
L4
Group
Value
95% CI
Low-level Therapy Intervention
7
Sham Intervention
4
Inferior Alveolar Nerve Function for Soft StimuliPrimary· 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
Group
Value
95% CI
Low-level Therapy Intervention
5
Sham Intervention
6
R2
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
9
R3
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
9
R4
Group
Value
95% CI
Low-level Therapy Intervention
7
Sham Intervention
7
L1
Group
Value
95% CI
Low-level Therapy Intervention
4
Sham Intervention
6
L2
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
9
L3
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
9
L4
Group
Value
95% CI
Low-level Therapy Intervention
5
Sham Intervention
5
Inferior Alveolar Nerve Function for Soft StimuliPrimary· 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
Group
Value
95% CI
Low-level Therapy Intervention
6
Sham Intervention
3
R2
Group
Value
95% CI
Low-level Therapy Intervention
6
Sham Intervention
6
R3
Group
Value
95% CI
Low-level Therapy Intervention
6
Sham Intervention
6
R4
Group
Value
95% CI
Low-level Therapy Intervention
6
Sham Intervention
4
L1
Group
Value
95% CI
Low-level Therapy Intervention
3
Sham Intervention
4
L2
Group
Value
95% CI
Low-level Therapy Intervention
6
Sham Intervention
6
L3
Group
Value
95% CI
Low-level Therapy Intervention
6
Sham Intervention
6
L4
Group
Value
95% CI
Low-level Therapy Intervention
3
Sham Intervention
4
Inferior Alveolar Nerve Function for Soft StimuliPrimary· 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
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
6
R2
Group
Value
95% CI
Low-level Therapy Intervention
9
Sham Intervention
8
R3
Group
Value
95% CI
Low-level Therapy Intervention
9
Sham Intervention
8
R4
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
6
L1
Group
Value
95% CI
Low-level Therapy Intervention
5
Sham Intervention
6
L2
Group
Value
95% CI
Low-level Therapy Intervention
9
Sham Intervention
8
L3
Group
Value
95% CI
Low-level Therapy Intervention
9
Sham Intervention
7
L4
Group
Value
95% CI
Low-level Therapy Intervention
5
Sham Intervention
6
Inferior Alveolar Nerve Function for Soft StimuliPrimary· 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
Group
Value
95% CI
Low-level Therapy Intervention
2
Sham Intervention
4
R2
Group
Value
95% CI
Low-level Therapy Intervention
4
Sham Intervention
5
R3
Group
Value
95% CI
Low-level Therapy Intervention
4
Sham Intervention
5
R4
Group
Value
95% CI
Low-level Therapy Intervention
2
Sham Intervention
4
L1
Group
Value
95% CI
Low-level Therapy Intervention
3
Sham Intervention
3
L2
Group
Value
95% CI
Low-level Therapy Intervention
4
Sham Intervention
5
L3
Group
Value
95% CI
Low-level Therapy Intervention
4
Sham Intervention
5
L4
Group
Value
95% CI
Low-level Therapy Intervention
2
Sham Intervention
4
Inferior Alveolar Nerve Function for Hard StimuliPrimary· 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
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
2
R2
Group
Value
95% CI
Low-level Therapy Intervention
11
Sham Intervention
8
R3
Group
Value
95% CI
Low-level Therapy Intervention
11
Sham Intervention
8
R4
Group
Value
95% CI
Low-level Therapy Intervention
7
Sham Intervention
2
L1
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
0
L2
Group
Value
95% CI
Low-level Therapy Intervention
11
Sham Intervention
6
L3
Group
Value
95% CI
Low-level Therapy Intervention
11
Sham Intervention
8
L4
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
4
Inferior Alveolar Nerve Function for Hard StimuliPrimary· 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
Group
Value
95% CI
Low-level Therapy Intervention
6
Sham Intervention
5
R2
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
9
R3
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
9
R4
Group
Value
95% CI
Low-level Therapy Intervention
7
Sham Intervention
5
L1
Group
Value
95% CI
Low-level Therapy Intervention
6
Sham Intervention
5
L2
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
8
L3
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
9
L4
Group
Value
95% CI
Low-level Therapy Intervention
5
Sham Intervention
5
Inferior Alveolar Nerve Function for Hard StimuliPrimary· 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
Group
Value
95% CI
Low-level Therapy Intervention
9
Sham Intervention
6
R2
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
8
R3
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
8
R4
Group
Value
95% CI
Low-level Therapy Intervention
9
Sham Intervention
6
L1
Group
Value
95% CI
Low-level Therapy Intervention
9
Sham Intervention
4
L2
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
8
L3
Group
Value
95% CI
Low-level Therapy Intervention
10
Sham Intervention
8
L4
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
5
Inferior Alveolar Nerve Function for Hard StimuliPrimary· 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
Group
Value
95% CI
Low-level Therapy Intervention
5
Sham Intervention
7
R2
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
9
R3
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
9
R4
Group
Value
95% CI
Low-level Therapy Intervention
7
Sham Intervention
8
L1
Group
Value
95% CI
Low-level Therapy Intervention
4
Sham Intervention
6
L2
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
9
L3
Group
Value
95% CI
Low-level Therapy Intervention
8
Sham Intervention
9
L4
Group
Value
95% CI
Low-level Therapy Intervention
5
Sham Intervention
5
Inferior Alveolar Nerve Function for Hard StimuliPrimary· 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
Group
Value
95% CI
Low-level Therapy Intervention
6
Sham Intervention
3
R2
Group
Value
95% CI
Low-level Therapy Intervention
6
Sham Intervention
6
R3
Group
Value
95% CI
Low-level Therapy Intervention
6
Sham Intervention
6
R4
Group
Value
95% CI
Low-level Therapy Intervention
5
Sham Intervention
3
L1
Group
Value
95% CI
Low-level Therapy Intervention
3
Sham Intervention
4
L2
Group
Value
95% CI
Low-level Therapy Intervention
6
Sham Intervention
6
L3
Group
Value
95% CI
Low-level Therapy Intervention
6
Sham Intervention
6
L4
Group
Value
95% CI
Low-level Therapy Intervention
3
Sham Intervention
3
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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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Albert Einstein College of Medicine
Last refreshed: 24 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04910074.