Nerve Injury Clinical Trial
Official title:
LLLT Effects on Inferior Alveolar Nerve (IAN)Recovery Post-orthognathic Surgery
NCT number | NCT04910074 |
Other study ID # | 2021-12990 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2022 |
Est. completion date | October 2024 |
Verified date | November 2023 |
Source | Albert Einstein College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Suspended |
Enrollment | 11 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Jacobi Medical Center, Department of Dentistry and Oral Surgery | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Albert Einstein College of Medicine |
United States,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative pain | Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible | 24 hours post-surgery | |
Primary | Post-operative pain | Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible | 1 week post-surgery | |
Primary | Post-operative pain | Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible | 2 weeks post-surgery | |
Primary | Post-operative pain | Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible | 3 weeks post-surgery | |
Primary | Post-operative pain | Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible | 4 weeks post-surgery | |
Primary | Post-operative pain | Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible | 5 weeks post-surgery | |
Primary | Post-operative pain | Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible | 6 weeks post-surgery | |
Primary | Post-operative pain | Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible | 8 weeks post-surgery | |
Primary | Post-operative pain | Pain indicated by visual analogue scale of 1 (least pain) to 10 (most pain possible), per side of mandible | 20 weeks post-surgery | |
Primary | Post-operative mandibular swelling | A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally. | 24 hours post-surgery | |
Primary | Post-operative mandibular swelling | A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally. | 1 week post-surgery | |
Primary | Post-operative mandibular swelling | A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally. | 2 weeks post-surgery | |
Primary | Post-operative mandibular swelling | A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally. | 3 weeks post-surgery | |
Primary | Post-operative mandibular swelling | A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally. | 4 weeks post-surgery | |
Primary | Post-operative mandibular swelling | A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally. | 5 weeks post-surgery | |
Primary | Post-operative mandibular swelling | A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally. | 6 weeks post-surgery | |
Primary | Post-operative mandibular swelling | A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally. | 8 weeks post-surgery | |
Primary | Post-operative mandibular swelling | A soft measuring tape, in mm, overlying skin from soft tissue menton to the base of the earlobe, bilaterally. | 20 weeks post-surgery | |
Primary | Inferior alveolar nerve function for soft stimuli | Cotton swab brushed in 2cm path onto skin of 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. | 24 hours post-surgery | |
Primary | Inferior alveolar nerve function for soft stimuli | Cotton swab brushed in 2cm path onto skin of 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. | 1 week post-surgery | |
Primary | Inferior alveolar nerve function for soft stimuli | Cotton swab brushed in 2cm path onto skin of 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. | 2 weeks post-surgery | |
Primary | Inferior alveolar nerve function for soft stimuli | Cotton swab brushed in 2cm path onto skin of 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. | 3 weeks post-surgery | |
Primary | Inferior alveolar nerve function for soft stimuli | Cotton swab brushed in 2cm path onto skin of 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. | 4 weeks post-surgery | |
Primary | Inferior alveolar nerve function for soft stimuli | Cotton swab brushed in 2cm path onto skin of 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. | 5 weeks post-surgery | |
Primary | Inferior alveolar nerve function for soft stimuli | Cotton swab brushed in 2cm path onto skin of 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. | 6 weeks post-surgery | |
Primary | Inferior alveolar nerve function for soft stimuli | Cotton swab brushed in 2cm path onto skin of 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. | 8 weeks post-surgery | |
Primary | Inferior alveolar nerve function for soft stimuli | Cotton swab brushed in 2cm path onto skin of 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. | 20 weeks post-surgery | |
Primary | Inferior alveolar nerve function for hard stimuli | Toothpick pressed into skin of 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. | 24 hours post-surgery | |
Primary | Inferior alveolar nerve function for hard stimuli | Toothpick pressed into skin of 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. | 1 week post-surgery | |
Primary | Inferior alveolar nerve function for hard stimuli | Toothpick pressed into skin of 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. | 2 weeks post-surgery | |
Primary | Inferior alveolar nerve function for hard stimuli | Toothpick pressed into skin of 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. | 3 weeks post-surgery | |
Primary | Inferior alveolar nerve function for hard stimuli | Toothpick pressed into skin of 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. | 4 weeks post-surgery | |
Primary | Inferior alveolar nerve function for hard stimuli | Toothpick pressed into skin of 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. | 5 weeks post-surgery | |
Primary | Inferior alveolar nerve function for hard stimuli | Toothpick pressed into skin of 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. | 6 weeks post-surgery | |
Primary | Inferior alveolar nerve function for hard stimuli | Toothpick pressed into skin of 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. | 8 weeks post-surgery | |
Primary | Inferior alveolar nerve function for hard stimuli | Toothpick pressed into skin of 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. | 20 weeks post-surgery |
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