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NCT04706182
Platelet-rich Fibrin and Grooving for Sagittal Split Osteotomy
NA trial testing Platelet-rich fibrin (PRF) in Inferior Alveolar Nerve Injury in 88 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | Jesse Han |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 88 |
| Start date | 1 February 2021 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Platelet-rich fibrin (PRF)
- Proximal segment grooving (PSG)
Conditions studied
- Inferior Alveolar Nerve Injury — all drugs for Inferior Alveolar Nerve Injury →
- Nerve Injury — all drugs for Nerve Injury →
- Neurosensory Disorder — all drugs for Neurosensory Disorder →
- Mandibular Nerve Injury — all drugs for Mandibular Nerve Injury →
Sponsor
Jesse Han
Who can join
18 and older, any sex, with Inferior Alveolar Nerve Injury or Nerve Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04706182
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Related trials
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- NCT06905860 — Intra-articular Infiltration of Platelet-Rich Fibrin vs Corticosteroid in Mild to Moderate Knee Osteoarthritis · Phase 4 · not yet recruiting
- NCT07530068 — Adjacent Molar Outcomes After Third Molar Surgery With PRF or Collagen Sponge · NA · completed
- NCT07022860 — Study on Platelet-Rich Fibrin for Preserving Jawbone After Tooth Extraction Using CBCT Imaging in Adults · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04706182 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jesse Han
- Last refreshed: 12 January 2021
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