Nerve Injury Clinical Trial
Official title:
Neurosensory Outcomes With Platelet-Rich Fibrin and Proximal Segment Grooving in Sagittal Split Osteotomy: A Randomized Clinical Trial
Sagittal split osteotomy (SSO) is a common operation done to move the mandible to correct dentofacial deformities and obstructive sleep apnea (OSA). Inferior alveolar nerve (IAN) injury and associated paresthesia is a well-known negative outcome following SSO, causing temporary or sometimes, permanent numbness in the chin and/or lip. There are limited methods to decrease the occurrence and duration of neurosensory dysfunction. Recent research has shown that platelet-rich fibrin (PRF) aids neurosensory recovery after SSO. Another method to minimize nerve injury is proximal segment grooving (PSG) to create space for the nerve to rest. This grooving method has never been formerly reported. The purpose of this study is to answer the following question: Among patients undergoing bilateral sagittal split osteotomy (BSSO) for dentofacial deformity or OSA, do those who receive PRF with or without PSG, compared to those who do not, have shorter times to functional sensory recovery (FSR) of the IAN? The null hypothesis is that there is no difference among 4 treatment groups and neurosensory outcomes. The specific aims of this proposal are to 1) enroll and randomize subjects who will undergo BSSO for correction of dentofacial deformity or OSA into 4 different treatment groups (PSG with PRF, PSG alone, PRF alone, neither PSG or PRF), 2) measure objective and subjective post-operative nerve function at fixed intervals post-operatively for up to 1 year, 3) compare differences in neurosensory outcomes among treatment groups, and 4) identify other variables that might be associated with differences in neurosensory outcomes.
Status | Recruiting |
Enrollment | 88 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Inclusion criteria include patients ages 18 and older, male or female, with a diagnosis of dentofacial deformity and/or OSA who will undergo BSSO. Exclusion Criteria: Exclusion criteria include patients with a history of previous mandibular surgery and preoperative neurosensory dysfunction of the trigeminal nerve. Other exclusion criteria are patients without capacity to consent for themselves or unable to read the consent form. Subjects who have conditions which may impair healing (such those on bisphosphonates treatments, blood thinners, corticosteroids, chemotherapy, etc.) will be excluded from participation in the research. |
Country | Name | City | State |
---|---|---|---|
United States | Dale S. Bloomquist, DDS, MS | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Jesse Han |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional sensory recovery (FSR) | Adopted by the British Medical Research Council (MRC) scale, the primary outcome will be FSR, as defined as static 2-point discrimination less than 20 mm and superficial pain/tactile sensation without over-reaction on exam. Neurosensory parameters assessed will be Level A: static light touch, brush stroke direction and static 2-point discrimination; Level B: tensile light touch, using von Frey's hairs; and Level C: pinprick sensation (pain) and temperature. | 1 year postoperative | |
Secondary | Subjective inferior alveolar nerve (IAN) function | Subjective IAN function will be measured using a visual analogue scale (VAS) and recorded as a continuous variable from 0-10. A score of 0 will represent anesthesia, 1-9 hypoesthesia and 10 normal. | 1 year postoperative |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT01437332 -
Molecular Mediators of Nerve Injury Signaling
|
N/A | |
Completed |
NCT03624426 -
Detection and Prevention of Nerve Injury in Shoulder Arthroplasty Surgery
|
N/A | |
Recruiting |
NCT04662320 -
Promoting Healing Of Nerves Through Electrical Stimulation
|
N/A | |
Recruiting |
NCT04144972 -
Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain
|
N/A | |
Completed |
NCT02960516 -
MRI Diffusion Tensor Tractography to Monitor Peripheral Nerve Recovery After Severe Crush or Cut/Repair Nerve Injury
|
||
Completed |
NCT05589324 -
Effects of 3D Printing Writing Assisitive Device on Feasibility in Patients With Nerve Injury
|
||
Recruiting |
NCT03970161 -
Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy
|
N/A | |
Completed |
NCT01533337 -
Free Dorsal Digital Flap for Reconstruction of Volar Soft Tissue Defect of Digits
|
N/A | |
Completed |
NCT01528397 -
Reconstruction of Proper Digital Nerve Defects in the Thumb Using a Pedicled Nerve Graft
|
N/A | |
Enrolling by invitation |
NCT05080608 -
Nerve Injury in the Hand, an Interview Study
|
||
Completed |
NCT03881462 -
Deltoid Muscle Contribution to Shoulder Function
|
N/A | |
Completed |
NCT05302141 -
Effects of Assistive Device on ADL Function in Patients With Nerve Injury
|
N/A | |
Terminated |
NCT01751503 -
Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer
|
N/A | |
Recruiting |
NCT05365282 -
Association Between Radial Artery Intervention and Development of Neuropathy in the Hand - A Prospective Study
|
||
Active, not recruiting |
NCT03701581 -
4-aminopyridine Treatment for Nerve Injury
|
Phase 2/Phase 3 | |
Withdrawn |
NCT04270019 -
Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration
|
Phase 1/Phase 2 | |
Completed |
NCT04420689 -
A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery
|
Phase 1/Phase 2 | |
Recruiting |
NCT05884125 -
Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
|
N/A | |
Recruiting |
NCT05611983 -
Experience and Feasibility of Methods for Early Sensory Training
|
N/A | |
Completed |
NCT02032030 -
Systematic Assessment and Targeted Improvement of Services Following Yearlong Surgical Outcomes Surveys
|