Platelet-rich Fibrin and Grooving for Sagittal Split Osteotomy

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    88
  • sponsor
    Jesse Han
Updated on 28 January 2021

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.

Details
Condition Nerve Injury, Neurosensory Disorder, nerve damage, neural injury, nerve injuries, sensory disturbances, sensory disorder, sensory disorders, Inferior Alveolar Nerve Injury, Mandibular Nerve Injury
Treatment Platelet-rich fibrin (PRF), Proximal segment grooving (PSG)
Clinical Study IdentifierNCT04706182
SponsorJesse Han
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Inclusion criteria include patients ages 18 and older, male or female, with a
diagnosis of dentofacial deformity and/or OSA who will undergo BSSO

Exclusion Criteria

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