Protocol summary

Study aim
Assessing how well processed autologous serum works to mend wounds in the face and jaw
Design
Ten patients participated in a phase one, double-blind, simple randomization clinical study with a control group and an intervention group. The "Random Allocation Rule" method was used for randomization.
Settings and conduct
After obtaining informed consent, ten patients with mandibular bone fractures who were referred to the Tabriz University of Medical Sciences Faculty of Dentistry clinic were split into two groups: one group received processed autologous serum, while the other group received treatments. The patients were chosen based on the pertinent criteria. They will be split up and given the routine. Then, in order to create processed autologous serum, 20 cc of blood from the intervention group will be extracted from the cubital vein and collected in a specialized Ertokin syringe. One milliliter of the prepared serum is injected into the target region three times on days 0, 3, and 7. The control group receives standard care. Using histology, histomorphometry, and tomography techniques, the healing of the formed bone lesions will be assessed one, three, and six months later.
Participants/Inclusion and exclusion criteria
Enter: Having trouble chewing food Tooth misalignment Teeth falling out or coming loose Not enter: Individuals with underlying medical conditions Individuals having issues with coagulation
Intervention groups
Intervention group: group that gets autologous serum that has been treated Control group: The control group, which will get standard care
Main outcome variables
The efficiency of processed autologous serum in treating lesions on the face and jaw

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160422027520N25
Registration date: 2024-12-10, 1403/09/20
Registration timing: registered_while_recruiting

Last update: 2024-12-10, 1403/09/20
Update count: 0
Registration date
2024-12-10, 1403/09/20
Registrant information
Name
Mehdi Yousefi
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4665
Email address
yousefime@tbzmed.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-11-22, 1404/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Autologous Conditioned Serum's impact on maxillofacial lesion healing
Public title
Investigating the impact of autologous serum on the healing of face and jaw injuries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Jaw dislocation or fracture accompanied with chin and tooth discomfort and edema Having trouble chewing food Tooth misalignment Teeth falling out or coming loose Joint pain in the jaw and trouble expanding the mouth
Exclusion criteria:
Individuals with underlying medical conditions Individuals having issues with coagulation Patients who are above 40 and younger than 18 Individuals with a history of asthma and medication allergies
Age
From 18 years old to 40 years old
Gender
Both
Phase
1
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, the sample size was determined to be 10 individuals with mandibular bone fractures who satisfied our inclusion requirements. The "Random Allocation Law" technique was used to the randomization process, writing the numbers 1 through 10 on the cards. The control group, which did not receive any therapy (other from the standard therapies), was assigned odd numbers, whereas the treatment group was assigned even numbers. By using this approach, the number of participants allocated to each group at the conclusion of the research is balanced. Each card was put in an opaque, sealed envelope to disguise the random distribution.
Blinding (investigator's opinion)
Double blinded
Blinding description
All participants in this research are not aware of their study group assignment, nor are those in charge of data collecting and analysis. This implies that participants are unaware of whether they are in the control group, which only receives regular therapies, or the intervention group, which receives autologous serum therapy in addition to normal treatments. All patients get standard restorative therapies, including antibiotics, steroidal anti-inflammatory medicines, and analgesics like acetaminophen or ibuprofen, and there is no placebo employed in the trial. They do not know whether they are in the control group or the intervention group, but only the intervention group gets autologous serum in addition to standard therapy. Additionally, those in charge of data collection and analysis are unaware of whether the data they gather and examine is from the intervention group or the control group. Prior to the study's randomization, participants were notified, and their informed permission was acquired. It should be mentioned that the individuals in charge of gathering and analyzing the data are not involved in any other aspects of this research.
Placebo
Not used
Assignment
Parallel
Other design features
Intervention group: The group that receives processed autologous serum. Control group: the one that will get standard care without getting processed autologous serum.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz,
City
Tabriz
Province
East Azarbaijan
Postal code
6446-14155
Approval date
2024-09-23, 1403/07/02
Ethics committee reference number
IR.TBZMED.REC.1403.515

Health conditions studied

1

Description of health condition studied
Facial and jaw lesions
ICD-10 code
S02.6
ICD-10 code description
Fracture of mandible

Primary outcomes

1

Description
The efficiency of processed autologous serum in treating lesions on the face and jaw
Timepoint
Examining the progress of the formed bone lesions one, three, and six months after the serum injection
Method of measurement
using techniques from microcomputer tomography, histomorphometry, and histology. Additionally, spectroscopy, bone density measurement, and gene expression study of bone morphogenetic proteins (BMP-2)

Secondary outcomes

empty

Intervention groups

1

Description
The group that received processed autologous serum was the intervention group. In order to create processed autologous serum, 20 cc of blood is extracted from the patient's cubital vein and placed in a specialized Ertokin syringe. In order to extract the processed serum, the blood in the Ertokine syringe is centrifuged at 1000 g for 10 minutes after being incubated for 8 hours at 37 degrees Celsius to release growth and anti-inflammatory factors. On days 0–3, the prepared serum is administered; each injection is one milliliter in volume. Using techniques from histology, histomorphometry, and CT-μ microcomputer tomography, the healing of the generated bone lesions will be examined one, three, and six months later.
Category
Treatment - Drugs

2

Description
The control group will get standard care. Using painkillers like acetaminophen or ibuprofen is part of these standard therapies. These therapies also involve the use of steroidal anti-inflammatory medications and antibiotics. The healing of the formed bone lesions will be assessed by CT-μ microcomputer tomography, histology, and histomorphometry techniques one, three, and six months later.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental Faculty Clinic, Tabriz University of Medical Sciences
Full name of responsible person
Mrs. Dr. Tanaz Porlak
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
6446-14155
Phone
+98 41 3327 3000
Email
mehdi_yusefi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
mehdi_yusefi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
mehdi_yusefi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
mehdi_yusefi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
mehdi_yusefi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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