Clinical Trials Logo
  1. Home
  2. Mandibular Nerve Injury
  3. NCT04706182

Platelet-rich Fibrin and Grooving for Sagittal Split Osteotomy

Nerve Injury Clinical Trial

Official title:
Neurosensory Outcomes With Platelet-Rich Fibrin and Proximal Segment Grooving in Sagittal Split Osteotomy: A Randomized Clinical Trial

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04706182
Study type Interventional
Source University of Washington
Contact Jesse T Han, DDS, MD
Phone 206-540-9857
Email jessehan@uw.edu
Status Recruiting
Phase N/A
Start date February 1, 2021
Completion date December 31, 2024
View Details
See also
  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