PRF + PSG for Mandibular Nerve Injury Recovery

Overseen By Thomas B Dodson, DMD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jesse Han

Must not be taking: Bisphosphonates, Blood thinners, Corticosteroids, others

Disqualifiers: Previous mandibular surgery, Neurosensory dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

88 Participants Needed

Trial Summary

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.

Research Team

Jesse Han, DDS, MD

Principal Investigator

University of Washington

Eligibility Criteria

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

I have been diagnosed with a jaw deformity or sleep apnea.

I am scheduled for or have had a jaw surgery.

I am 18 years old or older.

Exclusion Criteria

I have nerve issues in my face before surgery.

I have had surgery on my lower jaw before.

I am unable to understand or sign the consent form by myself.

Treatment Details

Interventions

• Platelet-rich fibrin (PRF)
• Proximal segment grooving (PSG)

Trial Overview The study tests if platelet-rich fibrin (PRF), grooving of the bone near the nerve during surgery (PSG), or both can help nerves recover after BSSO. Patients will be randomly assigned to one of four groups: PRF and PSG, just PRF, just PSG, or neither. Nerve function recovery will be tracked for up to a year.

Participant Groups

Group I: Only PSG Experimental Treatment 1 Intervention

Group II: Only PRF Experimental Treatment 1 Intervention

Group III: Combined PRF and PSG Experimental Treatment 2 Interventions

Group IV: Control (no treatment) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Jesse Han

Lead Sponsor

Trials

1

Recruited

90+