Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000397718
Ethics application status
Approved
Date submitted
24/01/2022
Date registered
8/03/2022
Date last updated
8/03/2022
Date data sharing statement initially provided
8/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation Of the Efficacy Of Injectable Platelet Rich Fibrin (I-PRF) In The Management Of Clicking In Internal Temporomandibular Joint Disorders
Scientific title
Evaluation Of the Efficacy Of Injectable Platelet Rich Fibrin (I-PRF) In The Management Of Clicking In Internal Temporomandibular Joint Disorders
Secondary ID [1] 306258 0
Nil known
Universal Trial Number (UTN)
U1111-1273-5059
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temporomandibular Joint Clicking 325002 0
Condition category
Condition code
Musculoskeletal 322439 322439 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients were asked to tell their own medical and dental history in his or her study visit which will spend 20 to 30 minutes. Observations were recorded in patient's medical examination forms, and the clicking was evaluated by the use of the Helkemo index. These values were recorded in a patient form before injecting the temporomandibular joint with injectable platelet rich fibrin. Clinical examination of the temporomandibular joint was conducted by the researcher and this study was based on a method called functional manual examination of the temporomandibular joint. This simple and comprehensive method was used to diagnose the symptoms of the temporomandibular joint with special emphasis on negating and neutralizing the effects of muscles in developing symptoms. For preparation of injectable platelet-rich fibrin, 20 mL peripheral blood was obtained from the ulnar vein and collected in sterile vacuum tubes used for one time. These tubes were put in a centrifuge at 700 rpm for 3 minutes. Thus, we got platelet concentrates in liquid form and not in the form of clots. This liquid is rich in white blood cells, platelets and growth factors. There were no additives.
For injection technique, the surgical site of the temporomandibular joint was disinfected by oral surgeon with povidone. The entry point of needle tip was determined by delimiting the anatomical features of the entry point, which was suggested by McCain (Nitzan DW et al., 1991)
We started with a line extending from the middle of the tragus to the lateral angle of the eye in the same side. The injection needle was entered about (10) mm from the middle of the pinna tragus and about (2) mm down the previously drawn line. An Insulin syringe was used and entered wholly (27 gauge in diameter, approximately 1 cm in length). The injection continued until a patient felt the pressure of the injection and the plunger turned back as the finger was removed. At this point, the injection was stopped and the needle was drawn immediately.

The following injection protocol was used. Each patient was injected 1 mL twice one week apart. One week after the first injection, patients were examined, the results were recorded and the second injection was performed in the same joint and in the same method. Since the second injection patients were followed for a period of six months. The clicking was evaluated by Helkimo scale.
Intervention code [1] 322673 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330220 0
Presence of clicking of TMJ assessed by Helkimo index
Timepoint [1] 330220 0
one week after first injection
one week after second injection
six months after first injection (primary timepoint)
Secondary outcome [1] 405279 0
Nil
Timepoint [1] 405279 0
Nil

Eligibility
Key inclusion criteria
The inclusion criteria were patients should be between 16-40 years old, all patients in the sample should not have systemic diseases that may affect the healing of soft and bone tissue, patients should not have undergone any previous surgeries in the TMJ and the patient should has unilateral clicking in the temporomandibular joint.
Minimum age
16 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria were patients with syndromes or growth disorders, osteoarthritis of the TMJ (advanced stages), TMJ disk perforation, patients with rheumatism, both types of TMJ intra-articular adhesion, patients with infectious arthritis, pregnant women or patients with bilateral arthralgia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/01/2020
Date of last participant enrolment
Anticipated
Actual
15/02/2021
Date of last data collection
Anticipated
Actual
23/08/2021
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 24518 0
Syrian Arab Republic
State/province [1] 24518 0
Damascus

Funding & Sponsors
Funding source category [1] 310609 0
University
Name [1] 310609 0
Damascus University
Country [1] 310609 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Almazah Street, Damascus, Syria
Country
Syrian Arab Republic
Secondary sponsor category [1] 311943 0
Hospital
Name [1] 311943 0
Oral and Maxillofacial Hospital
Address [1] 311943 0
Almazah Street, Damascus, Syria
Country [1] 311943 0
Syrian Arab Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310211 0
the Ethical Committee of the Faculty of Dentistry in Damascus University, Syria.
Ethics committee address [1] 310211 0
Ethics committee country [1] 310211 0
Syrian Arab Republic
Date submitted for ethics approval [1] 310211 0
Approval date [1] 310211 0
13/01/2020
Ethics approval number [1] 310211 0
287/4510

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116878 0
Dr Mustafa Manafikhi
Address 116878 0
Faculty of Dental Medicine, Damascus University, Almazah Street, Damascus, Syria
Country 116878 0
Syrian Arab Republic
Phone 116878 0
+963992287487
Fax 116878 0
Email 116878 0
[email protected]
Contact person for public queries
Name 116879 0
Jawdat M. Ataya
Address 116879 0
Faculty of Dental Medicine, Damascus University, Almazah Street, Damascus, Syria
Country 116879 0
Syrian Arab Republic
Phone 116879 0
+969992287487
Fax 116879 0
Email 116879 0
[email protected]
Contact person for scientific queries
Name 116880 0
Jawdat M.. Ataya
Address 116880 0
Faculty of Dental Medicine, Damascus University, Almazah Street, Damascus, Syria
Country 116880 0
Syrian Arab Republic
Phone 116880 0
+963992287487
Fax 116880 0
Email 116880 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It will depend on the journal which we will submit this article to.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluation of the efficacy of platelet rich fibrin (I-PRF) intra-articular injections in the management of internal derangements of temporomandibular joints - a controlled preliminary prospective clinical study.2022https://dx.doi.org/10.1186/s12891-022-05421-7
N.B. These documents automatically identified may not have been verified by the study sponsor.