Platelet-rich Fibrin and Grooving for Sagittal Split Osteotomy

Last updated: January 9, 2021
Sponsor: Jesse Han
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nerve Injury

Treatment

N/A

Clinical Study ID

NCT04706182
STUDY00011198
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Inclusion criteria include patients ages 18 and older, male or female, with a diagnosis ofdentofacial deformity and/or OSA who will undergo BSSO.

Exclusion

Exclusion Criteria: Exclusion criteria include patients with a history of previous mandibular surgery andpreoperative neurosensory dysfunction of the trigeminal nerve. Other exclusion criteria arepatients without capacity to consent for themselves or unable to read the consent form.Subjects who have conditions which may impair healing (such those on bisphosphonatestreatments, blood thinners, corticosteroids, chemotherapy, etc.) will be excluded fromparticipation in the research.

Study Design

Total Participants: 88
Study Start date:
February 01, 2021
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Dale S. Bloomquist, DDS, MS

    Seattle, Washington 98101
    United States

    Active - Recruiting

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