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The effect of platelet-rich fibrin on neurosensory recovery of inferior alveolar nerve injury after mandibular body fracture

Protocol summary

Study aim
The effect of platelet-rich fibrin on neurosensory recovery of inferior alveolar nerve injury after mandibular body fracture
Design
Randomized Controlled clinical trial, two sided blinded on 13 patients. Randomization done by Excel application
Settings and conduct
The study was conducted on patients referring to the maxillofacial surgery ward in Taleghani and Imam Hossein hospitals. All patients will undergo CT-Scan imaging. An informed consent will be obtained from all patients. Demographic information of the patients will be recorded. Both patient and the examiner will be blind relative to the surgery. PRF will be derived from the patients' venous blood. During the reconstruction of the body fracture, the PRF will be put on the IAN of one side as the treatment group. But, the fixation on the other side will be performed without putting the PRF as the control group 6 and 12 months later, the patients will undergo the neurosensory evaluations.
Participants/Inclusion and exclusion criteria
Inclusion: The patients with bilateral mandibular body fracture with less than 5mm displacement, who are candidates for open reduction internal fixation (ORIF) Exclusion: The patients with other types of fracture or those who are not a candidate for the ORIF treatment method, history of mandible genioplasty or orthognathic surgery, history of mandible trauma, history of mandibular fracture, apparent perioperative nerve injury, psychiatric medication, refusing to participate in the postoperative examinations, having systemic neuropathic diseases such as diabetes, and having no consent for participation in the study.
Intervention groups
PRF will be put on the IAN of one side as the treatment group. But, the fixation on the other side will be performed without putting the PRF as the control group
Main outcome variables
The two-point discrimination test, The brush directional stroke, Self-reported paresthesia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200922048799N2
Registration date: 2022-01-10, 1400/10/20
Registration timing: prospective

Last update: 2022-01-10, 1400/10/20
Update count: 0
Registration date
2022-01-10, 1400/10/20
Registrant information
Name
Hamidreza Moslemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4044 3580
Email address
hmoslemi71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-18, 1400/11/29
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of platelet-rich fibrin on neurosensory recovery of inferior alveolar nerve injury after mandibular body fracture
Public title
The effect of platelet-rich fibrin on neurosensory recovery of inferior alveolar nerve injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with bilateral mandibular body fracture with less than 5mm displacement, who are candidates for open reduction-internal fixation (ORIF)
Exclusion criteria:
Patients with other types of fracture or those who are not a candidate for the ORIF treatment method History of mandible genioplasty or orthognathic surgery History of mandible trauma History of mandibular fracture Obvious perioperative nerve injury Psychiatric medication Refusing to participate in the postoperative examinations Having neuropathic systemic diseases such as diabetes Having no consent for participation in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 13
More than 1 sample in each individual
Number of samples in each individual: 2
During the reconstruction of the body fracture, before the fixation of the fracture, the PRF will be put on the IAN of one side as the treatment group. But, the fixation on the other side will be performed without putting the PRF as the control group.
Randomization (investigator's opinion)
Randomized
Randomization description
During the reconstruction of the body fracture, before the fixation of the fracture, the PRF will be put on the IAN of one side as the treatment group. But, the fixation on the other side will be performed without putting the PRF as the control group. For this purpose, the right or left side will be selected randomly by a software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The neurosensory evaluations at three times including before the surgery (T0), 6 months after the surgery (T1), and 12 months after the surgery (T2) will be performed by an examiner who is unaware of the study groups and surgical process
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Research institute of dental sciences Shahid beheshti university of me
Street address
Shahid Beheshti School of Dentistry, Danshjoo BLVD, Velenjak, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2021-12-13, 1400/09/22
Ethics committee reference number
IR.SBMU.DRC.REC.1400.095

Health conditions studied

1

Description of health condition studied
Inferior Alveolar nerve neurosensory defect due to mandibular body fracture
ICD-10 code
S04.3
ICD-10 code description
Injury of trigeminal nerve

Primary outcomes

1

Description
The two-point discrimination test (TPD)
Timepoint
before the surgery (T0), 6 months after the surgery (T1), and 12 months after the surgery (T2)
Method of measurement
the minimum distance of two discriminable points, which is created by a needle on the lower lip and the mental area.

2

Description
The brush directional stroke discrimination test
Timepoint
before the surgery (T0), 6 months after the surgery (T1), and 12 months after the surgery (T2)
Method of measurement
performed by movement of a thin brush on the lower lip and the mental area and the patient must recognize the direction of the brush movement.

3

Description
Self reported paresthesia
Timepoint
before the surgery (T0), 6 months after the surgery (T1), and 12 months after the surgery (T2)
Method of measurement
using the visual analogue scale with a score range of (1-10) so that scores of (1 to 3), (4 to 6), and (7-10) are defined as mild, moderate, and severe, respectively.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Before the fixation of the fracture, the PRF will be put on the IAN of one side as the treatment group.
Category
Treatment - Surgery

2

Description
Control group: The fixation of the fracture will be performed without putting the PRF
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Hamidreza Moslemi
Street address
Arabi St., Yemen St , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 9982
Email
hmoslemi71@gmail.com

2

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Hamidreza Moslemi
Street address
Imam Hossein Hospital, Shahid Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
hmoslemi71@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
َAzita Tehranchi
Street address
Shahid Beheshti School of Dentistry, Danshjoo BLVD, Velenjak, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 1814
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamidreza Moslemi
Position
DMD, Postgraduate student of Oral and Maxillofacial Surgery
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Oral and Maxillofacial Surgery, Shahid Beheshti School of Dentistry, Danshjoo BLVD, Velenjak, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 4044 3580
Fax
Email
hmoslemi71@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Tabrizi
Position
Associate Professor in Department of Oral and Maxillofacial Surgery
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti School of Dentistry, Danshjoo BLVD, Velenjak, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 4044 3580
Email
tabmed@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamidreza Moslemi
Position
DMD, Postgraduate student of Oral and Maxillofacial Surgery
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Oral and Maxillofacial Surgery, Shahid Beheshti School of Dentistry, Danshjoo BLVD, Velenjak, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 4044 3580
Fax
Email
hmoslemi71@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
all collected deidentified on demand
When the data will become available and for how long
Starting in April 2023
To whom data/document is available
Academic institutions
Under which criteria data/document could be used
no more intervention or analysis allowed
From where data/document is obtainable
Email to Dr Hamidreza Moslemi hmoslemi71@gmail.com
What processes are involved for a request to access data/document
After the request was accepted by the authors, data will be sent to them.
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