UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022197 |
|---|---|
| Receipt number | 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 | 2021/11/07 13:43:58 |
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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
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
noriy@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Department of Oral and Maxillofacial Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025570
