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PRF + PSG for Mandibular Nerve Injury Recovery

N/A
Recruiting
Led By Jesse Han, DDS, MD
Research Sponsored by Jesse Han
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of dentofacial deformity and/or OSA
Undergoing BSSO
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year postoperative
Awards & highlights

Study Summary

This trial is testing whether using platelet-rich fibrin (PRF) or proximal segment grooving (PSG) can help with nerve recovery after sagittal split osteotomy (SSO).

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site where blood is drawn to make PRF and possible additional risks from modifying surgical techniques such as increased bleeding or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a jaw deformity or sleep apnea.
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I am scheduled for or have had a jaw surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year postoperative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Functional sensory recovery (FSR)
Secondary outcome measures
Subjective inferior alveolar nerve (IAN) function

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Only PSGExperimental Treatment1 Intervention
Group II: Only PRFExperimental Treatment1 Intervention
Group III: Combined PRF and PSGExperimental Treatment2 Interventions
Group IV: Control (no treatment)Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platelet-rich fibrin (PRF)
2020
N/A
~40

Find a Location

Who is running the clinical trial?

Jesse HanLead Sponsor
Jesse Han, DDS, MDPrincipal Investigator - University of Washington
University of Washington Medical Center

Media Library

Proximal segment grooving (PSG) Clinical Trial Eligibility Overview. Trial Name: NCT04706182 — N/A
Inferior Alveolar Nerve Injury Research Study Groups: Control (no treatment), Combined PRF and PSG, Only PRF, Only PSG
Inferior Alveolar Nerve Injury Clinical Trial 2023: Proximal segment grooving (PSG) Highlights & Side Effects. Trial Name: NCT04706182 — N/A
Proximal segment grooving (PSG) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04706182 — N/A
~20 spots leftby Jun 2025
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