Platelet-rich Fibrin on Nerve Regeneration After Bilatera... | NCT03159338

Studies
Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy

NCT03159338

Sponsor

Shiraz University of Medical Sciences

Status

Unknown status

Last Update Posted

Dec 7, 2017Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Paresthesia
Anesthesia, Local
Neurosensory Disorder

Interventions

Platelet rich fibrin
Placebo

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

May 30, 2018Estimated

Completion Date

Sep 30, 2018Estimated

First Submitted Date

May 2, 2017

First Submission Date that Met QC Criteria

May 16, 2017

First Posted Date

May 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2017

Last Update Posted Date

Dec 7, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Reza Tabrizi, Assistant professor of oral and maxillofacial surgery, Shiraz University of Medical SciencesPrincipal Investigator

Lead Sponsor

Shiraz University of Medical SciencesOTHER

Collaborators

Name	Class
Shahid Beheshti University of Medical Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

Patients who have mandibular deformity and will undergo bilateral sagittal split osteotomy will be included in the study.One side of the osteotomies randomly will be considered as study group and another side as a control group.In the study group , platelet rich fibrin will be placed after osteotomy and before rigid fixation.In the control group fixation will be done without Platelet-rich Fibrin. Before starting the surgical procedure, 20 mL of venous blood will take and placed in a centrifuge for 12 minutes with 28000rpm. After centrifugation, the cap will be removed from each tube and they will be placed into a sterile rack L-PRF™. Fibrin matrix will prepare. The L-PRF™ will be removed from the tube. Then, the clot right beneath the red blood cell clot will be placed on the surface tray and covered. Five minutes will be waited before removing and using the fibrin matrix.Neurosensory disturbance will be evaluated in 6 and 12 months after osteotomies by two-point discrimination (TPD) test and pin tactile discrimination(PTD) tests.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment group	Active Comparator	One side of osteotomies will be considered as a treatment arm (randomly) which Platelet rich fibrin will be used with rigid fixation	Biological: Platelet rich fibrin
Control group	Placebo Comparator	In control site , placebo gel will be placed before rigid fixation	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Platelet rich fibrin	Biological	Platelet rich fibrin will be prepared by taking 20 cc blood and centrifugation with 28000 rpm.	treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Two-point discrimination (TPD) test	Two point discrimination will be measured based on the distance of two points (mm)	TPD will be assessed after 6 months
Two-point discrimination	Two point discrimination will be measured based on the distance of two points (mm)	Two-point discrimination will be evaluated after12 months intervals

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have class II or III deformity and will undergo bilateral sagittal split osteotomy

Exclusion Criteria:

Patients who have bad split or obvious nerve injury during surgery will be removed from study inclusion

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Reza Tabrizi, DMD	Contact	+989125850829		tabmed@gmail.com

Overall Officials

Name	Affiliation	Role
Reza Tabrizi, DMD	Shiraz University of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shiraz university of medical sciences	Not yet recruiting	Shiraz			Iran

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010292	Paresthesia
D012678	Sensation Disorders

Ancestor Terms

ID	Term
D020886	Somatosensory Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

Masking Description

Investigator will be blunt about side of treatmen and control.None of surgical team will be as an investigator.Patients will unware about which side is treatment or control.

Who Masked

Participant