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

Time frame: 20 weeks post-surgery

Population: Study was terminated in advance of the 20-week timepoint and toothpick samples were not collected from any of the participants at 20 weeks post-surgery. Accordingly, there are no IAN function for hard stimuli results to report.

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 arm.

Time frame: 24 hours post-surgery

Population: 24-hour post-surgical follow-up visits were not conducted during this study. Many patients were still admitted at 24 hours post-procedure and were unable to be brought into the dental clinic. In addition, the instruments and equipment required to conduct this assessment were not available in the hospital in-patient rooms. As a result, toothpick samples were not obtained from any of the patients at 24 hours post-surgery and there is no IAN function for hard stimuli results data to report.

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 arm.

Time frame: 1 week post-surgery

Population: Toothpick samples were able to be collected from regions R1, R4, L1, and L4 in all 12 patients and from regions R2, R3, L2, and L3 in 11 of 12 patients in the Low-level therapy intervention arm who attended their Week 1 visit. Toothpick samples were able to be collected from regions R2, R3, L2, and L3 in all 8 patients and from regions R1, R4, L1, and L4 in 7 of 8 patients in the Sham intervention arm who attended their Week 1 visit.

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 arm.

Time frame: 2 weeks post-surgery

Population: Toothpick samples were able to be collected from all regions in all 10 patients in the Low-level therapy intervention arm who attended their Week 2 visit. Toothpick samples were able to be collected from all regions in all 9 patients in the Sham intervention arm with the exception of region L1 in which toothpick samples were able to be collected from 8 of 9 patients who attended their Week 2 visit.

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 arm.

Time frame: 3 weeks post-surgery

Population: Toothpick samples were able to be collected from all regions in all 10 patients in the Low-level therapy intervention arm and from all regions in all 8 patients in the Sham intervention arm who attended their Week 3 visit.

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 arm.

Time frame: 4 weeks post-surgery

Population: Toothpick samples were able to be collected from all regions in all 8 patients in the Low-level therapy intervention arm and from all regions in all 9 patients in the Sham intervention arm who attended their Week 4 visit.

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 arm.

Time frame: 5 weeks post-surgery

Population: Toothpick samples were able to be collected from regions L1 and L4 in all 7 patients and from regions R1, R2, R3, R4, L2, and L3 in 6 of 7 patients in the Low-level therapy intervention arm who attended their Week 5 visit. Toothpick samples were able to be collected from all regions in all 6 patients in the Sham intervention arm who attended their Week 5 visit.

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 arm.

Time frame: 6 weeks post-surgery

Population: Toothpick samples were able to be collected from all regions in all 9 patients in the Low-level therapy intervention arm and from all regions in all 8 patients in the Sham intervention arm who attended their Week 6 visit.

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 arm.

Time frame: 8 weeks post-surgery

Population: Toothpick samples were able to be collected from all regions in all 4 patients in the Low-level therapy intervention arm and from all regions in all 5 patients in the Sham intervention arm who attended their Week 8 visit. Due to a deviation one patient in the Sham group had toothpick samples collected at 7 weeks instead of the intended 8-week collection timepoint.

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 by study arm.

Time frame: 24 hours post-surgery

Population: 24-hour post-surgical follow-up visits were not conducted during this study. Many patients were still admitted at 24 hours post-procedure and were unable to be brought into the dental clinic. In addition, the instruments and equipment required to conduct this assessment were not available in the hospital in-patient rooms. As a result, cotton swab samples were not obtained from any of the patients at 24 hours post-surgery and there is no IAN function for soft stimuli results data to report.

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 by study arm.

Time frame: 1 week post-surgery

Population: Swab samples were able to be collected from regions R1, R4, L1, and L4 in all 12 patients and from regions R2, R3, L2, and L3 in 11 of 12 patients in the Low-level therapy intervention arm who attended their Week 1 visit. Swab samples were able to be collected from regions R2, R3, L2, and L3 in all 8 patients and from regions R1, R4, L1, and L4 in 7 of 8 patients in the Sham intervention arm who attended their Week 1 visit.

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 by study arm.

Time frame: 2 weeks post-surgery

Population: Swab samples were able to be collected from all regions in all 10 patients in the Low-level therapy intervention arm who attended their Week 2 visit. Swab samples were able to be collected from all regions in all 9 patients in the Sham intervention arm with the exception of regions R4 and L4 in which swab samples were able to be collected from 8 of 9 patients who attended their Week 2 visit.

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 by study arm.

Time frame: 3 weeks post-surgery

Population: Swab samples were able to be collected from all regions in all 10 patients in the Low-level therapy intervention arm and from all regions in all 8 patients in the Sham intervention arm who attended their Week 3 visit.

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 by study arm.

Time frame: 4 weeks post-surgery

Population: Swab samples were able to be collected from all regions in all 8 patients in the Low-level therapy intervention arm and from all regions in all 9 patients in the Sham intervention arm who attended their Week 4 visit.

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 by study arm.

Time frame: 5 weeks post-surgery

Population: Swab samples were able to be collected from regions L1 and L4 in all 7 patients and from regions R1, R2, R3, R4, L2, and L3 in 6 of 7 patients in the Low-level therapy intervention arm who attended their Week 5 visit. Swab samples were able to be collected from all regions in all 6 patients in the Sham intervention arm who attended their Week 5 visit.

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 by study arm.

Time frame: 6 weeks post-surgery

Population: Swab samples were able to be collected from all regions in all 9 patients in the Low-level therapy intervention arm and from all regions in all 8 patients in the Sham intervention arm who attended their Week 6 visit.

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 by study arm.

Time frame: 8 weeks post-surgery

Population: Swab samples were able to be collected from all regions in all 4 patients in the Low-level therapy intervention arm and from all regions in all 5 patients in the Sham intervention arm who attended their Week 8 visit. Due to a deviation one patient in the Sham group had swab samples collected at Week 7 instead of the intended 8-week timepoint.

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 by study arm.

Time frame: 20 weeks post-surgery

Population: Study was terminated in advance of the 20-week timepoint and swab samples were not collected from any of the participants at 20 weeks post-surgery. Accordingly, there are no IAN function for soft stimuli results to report.

Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.

Time frame: 20 weeks post-surgery

Population: Study was terminated in advance of the 20-week timepoint and post-operative mandibular swelling measurements were not collected from any of the participants at 20 weeks post-surgery. Accordingly, there are no post-operative mandibular swelling results to report.

Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.

Time frame: 24 hours post-surgery

Population: 24-hour post-surgical follow-up visits were not conducted during this study. Many patients were still admitted at 24 hours post-procedure and were unable to be brought into the dental clinic. In addition, the instruments and equipment required to conduct this assessment were not available in the hospital in-patient rooms. As a result, mandibular swelling measurements were not obtained from any of the patients at 24 hours post-surgery and there is no mandibular swelling results data to report.

Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.

Time frame: 1 week post-surgery

Population: 1-week post-operative mandibular swelling data was able to be collected from all 12 patients in the Low-level therapy intervention arm and from all 8 patients in the Sham intervention arm who attended their Week 1 visit.

Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.

Time frame: 2 weeks post-surgery

Population: 2-week post-operative mandibular swelling data was able to be collected from all 10 patients in the Low-level therapy intervention arm and from all 9 patients in the Sham intervention arm who attended their Week 2 visit.

Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.

Time frame: 3 weeks post-surgery

Population: 3-week post-operative mandibular swelling data was able to be collected from all 10 patients in the Low-level therapy intervention arm and from 7 of 8 patients in the Sham intervention arm who attended their 3-week visit.

Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.

Time frame: 4 weeks post-surgery

Population: 4-week post-operative mandibular swelling data was able to be collected from all 8 patients in the Low-level therapy intervention arm and from all 9 patients in the Sham intervention arm who attended their Week 4 visit.

Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.

Time frame: 5 weeks post-surgery

Population: 5-week post-operative mandibular swelling data was able to be collected from all 7 patients in the Low-level therapy intervention arm and from all 6 patients in the Sham intervention arm who attended their Week 5 visit.

Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.

Time frame: 6 weeks post-surgery

Population: 6-week post-operative mandibular swelling data was able to be collected from all 9 patients in the Low-level therapy intervention arm and from all 8 patients in the Sham intervention arm who attended their Week 6 visit.

Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.

Time frame: 8 weeks post-surgery

Population: 8-week post-operative mandibular swelling data was able to be collected from all 4 patients in the Low-level therapy intervention arm and from all 5 patients in the Sham intervention arm who attended their Week 8 visit. Due to a deviation one patient in the Sham group had Post-operative mandibular swelling data collected at 7 weeks instead of the intended 8-week collection timepoint.

Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.

Time frame: 24 hours post-surgery

Population: 24-hour post-surgical follow-up visits were not conducted during this study. Many patients were still admitted at 24 hours post-procedure and were unable to be brought into the dental clinic. In addition, the instruments and equipment required to conduct this assessment were not available in the hospital in-patient rooms. As a result, VAS scores were not obtained from any of the patients at 24 hours post-surgery and there are no post-operative pain results data to report.

Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.

Time frame: 1 week post-surgery

Population: 1-week post-operative pain (VAS) data was able to be collected from all 12 patients in the Low-level therapy intervention arm and from all 8 patients in the Sham intervention arm who attended their Week 1 visit.

Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.

Time frame: 2 weeks post-surgery

Population: 2-week post-operative pain (VAS) data was able to be collected from 9 of 10 patients in the Low-level therapy intervention arm and from all 9 patients in the Sham intervention arm who attended their Week 2 visit.

Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.

Time frame: 3 weeks post-surgery

Population: 3-week post-operative pain (VAS) data was able to be collected from 9 of 10 patients in the Low-level therapy intervention arm and from all 8 patients in the Sham intervention arm who attended their Week 3 visit.

Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.

Time frame: 8 weeks post-surgery

Population: 8-week post-operative pain (VAS) data was able to be collected from all 4 patients in the Low-level therapy intervention arm and from all 5 patients in the Sham intervention arm who attended their Week 8 visit. Due to a deviation one patient in the Sham group had VAS data collected at 7 weeks instead of the intended 8-week collection timepoint.

Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.

Time frame: 4 weeks post-surgery

Population: 4-week post-operative pain (VAS) data was able to be collected from all 8 patients in the Low-level therapy intervention arm and from all 9 patients in the Sham intervention arm who attended their Week 4 visit.

Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.

Time frame: 5 weeks post-surgery

Population: 5-week post-operative pain (VAS) data was able to be collected from all 7 patients in the Low-level therapy intervention arm and from all 6 patients in the Sham intervention arm who attended their Week 5 visit.

Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.

Time frame: 6 weeks post-surgery

Population: 6-week post-operative pain (VAS) data was able to be collected from all 9 patients in the Low-level therapy intervention arm and from all 8 patients in the Sham intervention arm who attended their Week 6 visit.

Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.

Time frame: 20 weeks post-surgery

Population: Study was terminated in advance of the 20-week timepoint and the VAS questionnaire was not administered to, nor were data collected from, any of the participants at 20 weeks post-surgery. Accordingly, there are no post-operative pain results to report.