UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Study of autologous blood injection for the treatment of recurrent temporomandibular joint dislocation
Acronym	Autologous blood injection for recurrent temporomandibular joint dislocation
Scientific Title	Clinical Study of autologous blood injection for the treatment of recurrent temporomandibular joint dislocation
Scientific Title:Acronym	Autologous blood injection for recurrent temporomandibular joint dislocation
Region	Japan

Condition
Condition	Recurrent temporomandibular joint (TMJ) dislocation
Classification by specialty	Oral surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of the autologous blood injection for the recurrent TMJ dislocation and to standardize its procedure.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	At follow-up 6 months after the procedure, there is no episode of TMJ dislocation.
Key secondary outcomes	Improvement of QOL by decreasing the frequency of TMJ dislocation.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	1) The procedure is applied under local anesthesia. The skin overlying the TMJ is scrubbed with 10% povidone iodine and local anesthesia with 1% lidocaine including 1/80000 adrenaline is given to the preauricular area. 2) The auricular fossa is located at a point 10mm anterior to the tragus of the ear and 2mm inferior to the tragal-canthal line. At this location, 21-gauge needle is inserted into the superior joint space. When the needle tip is achieved to the superior joint space, the resistance force is reduced. After confirming the needle is placed at the correct position, the joint space is flashed with 5ml of saline via T-shaped stopcock. The 21-gauge needle is left at the position, then 5 ml of blood is drawn from the patient's anticubital fossa. 3) The syringe is connected to the previous inserted needle and blood is injected-3ml in the superior joint space and 1 ml in the pericapsular tissue. 4) After completion of the injection procedures, patients are instructed to restrict their mouth opening and to eat only soft foods for 7 days. 5) In case of the relapse of TMJ dislocation, autologous blood injection can be repeated.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) The patient was diagnosed as having recurrent TMJ dislocation based on the clinical criteria of Nitzan. The patient has the episodes of condylar dislocation for several times. 2) The conservative methods including restriction of the mandibular motions with chin cap, bandage, maxillomandibular fixation, or mouth opening training based on the self-reduce TMJ dislocation were ineffective. 3) A written informed consent must be obtained by an investigator from the patient or the legally authorized representative before the procedure.
Key exclusion criteria	1) Inflammatory diseases of temporomandibular joint, such as rheumatoid arthritis, tuberculous arthritis. 2) Evidence of tumor or tumor like lesion in the TMJ. 3) Temporomandibular disorders caused by metabolic diseases, including crystal deposition diseases such as gout, pseudogout, or crystal arthritis. 4) Intercurrent facial palsy. 5) Serious concomitant systemic disorder, including malignant hypertension, history of severe cardiovascular diseases or cerebrovascular disorders within 6 months, hemorrhagic gastric ulcers, uncontrolled diabetes, apparent bleeding tendency. 6) Under anticoagulant therapy. 7) Suspicion for active infection. 8) History of serious psychiatric illness or psychiatry illness under medical treatment. 9) Others diagnosed as inapplicable cases by an investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name AKIRA Middle name Last name SASAKI
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Oral and Maxillofacial Surgery
Zip code	7008525
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-6702
Email	aksasaki@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name NORIE Middle name Last name YOSHIOKA
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Oral and Maxillofacial Surgery
Zip code	7008525
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-6702
Homepage URL
Email	noriy@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Department of Oral and Maxillofacial Surgery
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Okayama University Graduate School of Medicine, Dentistry and Phrmaceutical Sciences and Okayama University Hospital, Ethic committee
Address	Okayama shi, Kita-ku Shikata-cho 2-5-1
Tel	086-235-6938
Email	mae6605@adm.okayama-u.a.cjp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	岡山大学病院（岡山県）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 06 Month 23 Day
Date of IRB	2015 Year 06 Month 23 Day
Anticipated trial start date	2016 Year 05 Month 09 Day
Last follow-up date	2023 Year 05 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 05 Month 03 Day
Last modified on	2021 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025570