ParesthesiaNCT03159338
Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy
A study testing Platelet rich fibrin in people with Paresthesia and Anesthesia, Local, run by Shiraz University of Medical Sciences at 2 sites in Iran.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Paresthesia, Anesthesia, Local, Neurosensory Disorder
- What is being tested?
- Platelet rich fibrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesIran
- Study dates
- 1 Sep 2017to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who have class II or III deformity and will undergo bilateral sagittal split osteotomy
Who cannot join
- Patients who have bad split or obvious nerve injury during surgery will be removed from study inclusion
Trial locations and contacts
2 sites in 1 country.
Iran2 sites, 2 recruiting
- Not yet recruiting
Shiraz university of medical sciences
Shiraz
Reza Tabrizi, DMD, 09125850829, tabmed@gmail.com
00987136280458
- Recruiting
Taleghani Hospital
Tehran
Fahimeh Akhlaghi, DMD
About this study
Official title: The Effect of Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy of the Mandible
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 (PRF).Neurosensory disturbance will be evaluated 6 and 12 months after surgeries.
Read the 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.
- Conditions
- Paresthesia, Anesthesia, Local, Neurosensory Disorder
- Being tested
- Platelet rich fibrin, Placebo
- Medical subject headings
- Paresthesia, Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrinBiological
Platelet rich fibrin will be prepared by taking 20 cc blood and centrifugation with 28000 rpm.
PlaceboBiological
In control group , after spliting the osteotomy site before fixation a placebo gel will be placed
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Platelet rich fibrin |
| Control group | Placebo comparator | In control site , placebo gel will be placed before rigid fixation Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-point discrimination (TPD) test
Two point discrimination will be measured based on the distance of two points (mm)
Measured: TPD will be assessed after 6 months
Two-point discrimination
Two point discrimination will be measured based on the distance of two points (mm)
Measured: Two-point discrimination will be evaluated after12 months intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start1 Sep 2017
- Primary completion30 May 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- one side of osteotomies randomally will be considered as a treatment group and another side as a control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Responsible party
- Principal investigator, Reza Tabrizi, Shiraz University of Medical Sciences
- Investigators
- Reza Tabrizi, DMD, Principal investigator, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159338
- Sponsor's protocol ID
- 30345
- Status last verified
- Dec 2017
- First submitted
- 2 May 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy of the Mandible
- ClinicalTrials.gov ID
- NCT03159338
- Acronym / sponsor ID
- 30345
- Conditions
- Paresthesia, Anesthesia, Local, Neurosensory Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 May 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (PRF).Neurosensory disturbance will be evaluated 6 and 12 months after surgeries.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- one side of osteotomies randomally will be considered as a treatment group and another side as a control group.
| Arm | Type | Receives |
|---|---|---|
| treatment group | Active comparator | Biological: Platelet rich fibrinOne side of osteotomies will be considered as a treatment arm (randomly) which Platelet rich fibrin will be used with rigid fixation |
| Control group | Placebo comparator | Biological: PlaceboIn control site , placebo gel will be placed before rigid fixation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who have class II or III deformity and will undergo bilateral sagittal split osteotomy
Key exclusion criteria (1 listed)
- Patients who have bad split or obvious nerve injury during surgery will be removed from study inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich fibrinPlatelet rich fibrin will be prepared by taking 20 cc blood and centrifugation with 28000 rpm. | Biological | treatment group |
| PlaceboIn control group , after spliting the osteotomy site before fixation a placebo gel will be placed | Biological | Control group |
Primary outcome
Two-point discrimination (TPD) test
Time frame: TPD will be assessed after 6 months
Two point discrimination will be measured based on the distance of two points (mm)
Two-point discrimination
Time frame: Two-point discrimination will be evaluated after12 months intervals
Two point discrimination will be measured based on the distance of two points (mm)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Paresthesia
Not yet recruitingPhase 2
Effectiveness of Oxitard Gel Versus Physiotherapeutic and Pharmacological Interventions in Alleviating Oral Submucous Fibrosis: A Phase-II Randomized Control Trial
Oral and Maxillofacial Conditions
RecruitingPhase 2
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain
Active, not recruiting
Paresthesia-Free Fast-Acting Subperception (FAST) Study
Chronic Pain
RecruitingPhase 2/3
Gut Microbiome Profiles in Patients With Chemotherapy-induced Neuropathy in the RCT OzoParQT (NCT06706544).
Chemotherapy Induced Peripheral Neuropathy (CIPN), Paresthesia
RecruitingPhase 2/3
Ozone Treatment in Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN), Paresthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reza Tabrizi, DMD principal investigator
Shiraz University of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich fibrin in people with Paresthesia and Anesthesia, Local, run by Shiraz University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reza Tabrizi, DMD (+989125850829, tabmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-point discrimination (TPD) test (time frame: TPD will be assessed after 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.