PRF + PSG for Mandibular Nerve Injury Recovery
What You Need to Know Before You Apply
What is the purpose of this 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.
Who Is on the Research Team?
Jesse Han, DDS, MD
Principal Investigator
University of Washington
Are You a Good Fit for This Trial?
This trial is for adults with dentofacial deformities or obstructive sleep apnea who are undergoing a jaw surgery called bilateral sagittal split osteotomy (BSSO). It's not for those who've had previous jaw surgeries, existing nerve issues in the face, trouble understanding the consent process, or conditions that affect healing like being on certain medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo bilateral sagittal split osteotomy (BSSO) with randomization into 4 treatment groups: PSG with PRF, PSG alone, PRF alone, or neither PSG nor PRF
Post-operative Monitoring
Objective and subjective post-operative nerve function is measured at fixed intervals
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Platelet-rich fibrin (PRF)
- Proximal segment grooving (PSG)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jesse Han
Lead Sponsor