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

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if certain treatments can reduce nerve injury after bilateral sagittal split osteotomy (BSSO), a surgery used to correct jaw deformities or sleep apnea. The treatments being tested are platelet-rich fibrin (PRF), which may aid nerve recovery, and proximal segment grooving (PSG), a method that creates space for the nerve. Participants will be assigned to one of four groups: PRF and PSG together, PRF alone, PSG alone, or no treatment, to identify which approach best accelerates nerve recovery. The trial seeks individuals planning to undergo BSSO surgery for jaw issues or obstructive sleep apnea. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery outcomes for future patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but if you are on treatments like bisphosphonates, blood thinners, corticosteroids, or chemotherapy, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, platelet-rich fibrin (PRF) showed promise in aiding nerve healing after surgery. Research indicates that PRF is generally safe and well-tolerated. For example, one study found PRF to be a practical treatment without major safety concerns for patients with other conditions. Another study showed PRF helped with healing and had no severe side effects.

Proximal segment grooving (PSG) is newer and lacks extensive safety data. However, similar surgical techniques have been used safely to aid nerve recovery. This suggests PSG might be safe, but more research is needed to confirm this.

In summary, PRF has a proven safety record, while PSG requires further study to confirm its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for mandibular nerve injury recovery because they offer innovative approaches that differ from standard options like medication, physical therapy, or surgery. Platelet-rich fibrin (PRF) is unique because it uses the patient's own blood components to promote healing and tissue regeneration, potentially speeding up recovery and reducing complications. Proximal segment grooving (PSG) introduces a novel mechanical technique to enhance nerve repair, which could improve outcomes when used alone or in combination with PRF. Together, these treatments might offer a more natural and effective way to restore nerve function compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for mandibular nerve injury recovery?

Research has shown that platelet-rich fibrin (PRF), which participants in this trial may receive, can help repair damaged nerves in the jaw. Studies indicate that PRF significantly reduces pain after surgery, suggesting it aids in healing. Although specific data on proximal segment grooving (PSG) is limited, the concept involves creating space for the nerve to potentially lower the risk of injury. This trial will test PRF alone, PSG alone, and a combination of both treatments to improve nerve recovery after jaw surgery. Early findings suggest both methods could speed up the return of sensation in the chin and lip area. ^{1 2 3 6 7}

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

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

I am scheduled for or have had a jaw surgery.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

Surgical procedure

Post-operative Monitoring

Objective and subjective post-operative nerve function is measured at fixed intervals

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11562979/

Does Platelet-Rich Fibrin Enhance Recovery From ... The results of this split-mouth randomized clinical trial indicate that PRF may enhance the recovery of a damaged inferior alveolar nerve in mandibular body ...

2. clinicaltrial.be clinicaltrial.be/en/details/48822?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Platelet-rich Fibrin and Grooving for Sagittal Split Oste... Recent research has shown that platelet-rich fibrin (PRF) aids neurosensory recovery after SSO. Another method to minimize nerve injury is ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6327825/

Healing Potential of Platelet Rich Fibrin in Impacted ... The aim of this study is to evaluate the effectiveness of PRF on soft-tissue healing and bone tissue healing in terms of postoperative pain, postoperative ...

4. researchgate.net researchgate.net/publication/383836904_Effectiveness_of_Platelet-Rich_Fibrin_PRF_in_Enhancing_Healing_and_Regeneration_in_Oral_and_Maxillofacial_Surgery_A_Quantitative_Narrative_Review_PRF_in_Oral_and_Maxillofacial_Surgery

(PDF) Effectiveness of Platelet-Rich Fibrin (PRF) in ... Results: PRF significantly improved bone regeneration (SMD: 0.85), accelerated soft tissue healing (SMD: 0.74), and reduced postoperative complications (RR: ...

5. head-face-med.biomedcentral.com head-face-med.biomedcentral.com/articles/10.1186/s13005-025-00482-0

Evaluation of the usefulness of platelet-rich fibrin (PRF) in ... A study conducted by Shruthi et al. showed encouraging data with a significant reduction in pain on the second, third, and seventh days after ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03159338

Platelet-rich Fibrin on Nerve Regeneration After Bilateral ... Patients will unware about which side is treatment or control. Platelet rich fibrin will be prepared by taking 20 cc blood and centrifugation with 28000 rpm.

7. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-019-0824-3

Impact of platelet-rich fibrin on mandibular third molar surgery ... The present study investigated and evaluated the efficacy and safety of platelet-rich fibrin (PRF) in patients during bilateral mandibular ...