UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054982 |
|---|---|
| Receipt number | R000062823 |
| Scientific Title | Clinical characteristics of patients with temporomandibular joint ankylosis in our department (retrospective study) |
| Date of disclosure of the study information | 2024/07/16 |
| Last modified on | 2024/07/16 19:43:32 |
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Basic information
Public title
Clinical characteristics of patients with temporomandibular joint ankylosis in our department (retrospective study)
Acronym
Clinical characteristics of patients with temporomandibular joint ankylosis in our department (retrospective study)
Scientific Title
Clinical characteristics of patients with temporomandibular joint ankylosis in our department (retrospective study)
Scientific Title:Acronym
Clinical characteristics of patients with temporomandibular joint ankylosis in our department (retrospective study)
Region
| Japan |
Condition
Condition
temporomandibular joint ankylosis
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Treatment of osseous temporomandibular joint ankylosis (TMJA) often requires a surgical procedure. While postoperative rehabilitation is important for prevention of relapse, the contributions of rehabilitation and period of such therapy remain unclear. The present study was aimed to evaluate the effects of rehabilitation on range of mouth opening after surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mouth opening (before surgery, 1 year after surgery, 2 years after surgery), rehabilitation period
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent surgical treatment for TMJA
Key exclusion criteria
Patients who have had surgery within 2 years
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yushi |
| Middle name | |
| Last name | Ezoe |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Oral and Maxillofacial Reconstructive Surgery
Zip code
980-8575
Address
4-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi Prefecture
TEL
0227178350
geka0329@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yushi |
| Middle name | |
| Last name | Ezoe |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Oral and Maxillofacial Surgery
Zip code
980-8575
Address
4-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi Prefecture
TEL
0227178350
Homepage URL
geka0329@dent.tohoku.ac.jp
Sponsor or person
Institute
Division of Oral and Maxillofacial Reconstructive Surgery,Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Division of Oral and Maxillofacial Reconstructive Surgery,Tohoku University Graduate School of Dentistry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Oral and Maxillofacial Surgery, Tohoku University Graduate School of Dentistry
Address
4-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi Prefecture
Tel
0227178350
geka0329@dent.tohoku.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 16 | 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
12
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
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study involved 12 cases, and the investigation of the outcome measures were completed.
Management information
Registered date
| 2024 | Year | 07 | Month | 16 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062823
