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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022197
Receipt No. R000025570
Scientific Title Clinical Study of autologous blood injection for the treatment of recurrent temporomandibular joint dislocation
Date of disclosure of the study information 2016/05/09
Last modified on 2020/05/06

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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
2020 Year 05 Month 06 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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