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Platelet-rich Fibrin and Grooving for Sagittal Split Osteotomy

Primary Purpose

Inferior Alveolar Nerve Injury, Nerve Injury, Neurosensory Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Platelet-rich fibrin (PRF)
Proximal segment grooving (PSG)
Sponsored by
Jesse Han
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inferior Alveolar Nerve Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dale S. Bloomquist, DDS, MSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Combined PRF and PSG

Only PRF

Only PSG

Control (no treatment)

Arm Description

Outcomes

Primary Outcome Measures

Functional sensory recovery (FSR)
Adopted by the British Medical Research Council (MRC) scale, the primary outcome will be FSR, as defined as static 2-point discrimination less than 20 mm and superficial pain/tactile sensation without over-reaction on exam. Neurosensory parameters assessed will be Level A: static light touch, brush stroke direction and static 2-point discrimination; Level B: tensile light touch, using von Frey's hairs; and Level C: pinprick sensation (pain) and temperature.

Secondary Outcome Measures

Subjective inferior alveolar nerve (IAN) function
Subjective IAN function will be measured using a visual analogue scale (VAS) and recorded as a continuous variable from 0-10. A score of 0 will represent anesthesia, 1-9 hypoesthesia and 10 normal.

Full Information

First Posted
January 9, 2021
Last Updated
January 9, 2021
Sponsor
Jesse Han
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1. Study Identification

Unique Protocol Identification Number
NCT04706182
Brief Title
Platelet-rich Fibrin and Grooving for Sagittal Split Osteotomy
Official Title
Neurosensory Outcomes With Platelet-Rich Fibrin and Proximal Segment Grooving in Sagittal Split Osteotomy: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jesse Han

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inferior Alveolar Nerve Injury, Nerve Injury, Neurosensory Disorder, Mandibular Nerve Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined PRF and PSG
Arm Type
Experimental
Arm Title
Only PRF
Arm Type
Experimental
Arm Title
Only PSG
Arm Type
Experimental
Arm Title
Control (no treatment)
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Platelet-rich fibrin (PRF)
Intervention Description
Platelet rich fibrin (PRF) serves as a structural reservoir of cytokines such as platelet-derived growth factor (PDGF), transforming growth factor (TGF-b), insulin-like growth factor (IGF), platelet factor 4 (PF4) and vascular endothelial growth factor (VEGF) which aids in healing and preventing infection. PRF will be prepared as recommended by the manufacturer (Intra-Lock International) by centrifuging 20 mL of the subject's venous blood for 12 minutes at 2700 rpm, followed by compression. The fibrin clot will then be applied to the SSO site prior to fixation. The blood draw for the PRF will be performed approximately 15 minutes prior to fixation of the mandible. 20 mL will be drawn for each PRF side treated. The blood venous draw will be from the subject's arm or from an existing intra-venous line.
Intervention Type
Procedure
Intervention Name(s)
Proximal segment grooving (PSG)
Intervention Description
Proximal segment grooving is a mechanical method to create additional space within the inferior alveolar canal to allow the IAN to rest without compression or trauma. The surgeon uses a round or acrylic bur to cautiously remove any bony spicules, and remove cancellous bone in the proximal mandibular segment. PSG will be done by using an acrylic round bur on a surgical handpiece to remove 3 to 4 mm of cancellous bone where the IAN will passively rest into prior to fixation.
Primary Outcome Measure Information:
Title
Functional sensory recovery (FSR)
Description
Adopted by the British Medical Research Council (MRC) scale, the primary outcome will be FSR, as defined as static 2-point discrimination less than 20 mm and superficial pain/tactile sensation without over-reaction on exam. Neurosensory parameters assessed will be Level A: static light touch, brush stroke direction and static 2-point discrimination; Level B: tensile light touch, using von Frey's hairs; and Level C: pinprick sensation (pain) and temperature.
Time Frame
1 year postoperative
Secondary Outcome Measure Information:
Title
Subjective inferior alveolar nerve (IAN) function
Description
Subjective IAN function will be measured using a visual analogue scale (VAS) and recorded as a continuous variable from 0-10. A score of 0 will represent anesthesia, 1-9 hypoesthesia and 10 normal.
Time Frame
1 year postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesse T Han, DDS, MD
Phone
206-540-9857
Email
jessehan@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas B Dodson, DMD, MPH
Email
tbdodson@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse Han, DDS, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dale S. Bloomquist, DDS, MS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dale S Bloomquist, DDS, MS
Email
daleb@uw.edu
First Name & Middle Initial & Last Name & Degree
Jesse T Han, DDS, MD
Email
jessehan@uw.edu

12. IPD Sharing Statement

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Platelet-rich Fibrin and Grooving for Sagittal Split Osteotomy

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