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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

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year postoperative

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

0 / 2Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current tally of participants for this clinical experiment?

"Affirmative. Evidence on clinicaltrials.gov proves that this research project, first published on February 1st 2021, is presently enrolling patients. The trial aims to bring in 88 subjects across one site."

Answered by AI

Are there any current opportunities to join this scientific experiment?

"The clinical trial, which was initially uploaded to clinicaltrials.gov on the 1st of February 2021 and recently edited on the 9th of January 2021, is currently seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Platelet-rich Fibrin and Grooving for Sagittal Split Osteotomy

Jesse Han 2021. "Platelet-rich Fibrin and Grooving for Sagittal Split Osteotomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04706182.