UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050457 |
|---|---|
| Receipt number | R000057470 |
| Scientific Title | A study on craniofacial skeletal patterns and occlusal reconstruction in aged persons |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/03/01 13:05:02 |
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Basic information
Public title
A study on the craniofacial skeletal patterns and occlusal reconstruction in aged persons
Acronym
A study on the facial skeleton and occlusion in aged persons
Scientific Title
A study on craniofacial skeletal patterns and occlusal reconstruction in aged persons
Scientific Title:Acronym
A study on the facial skeleton and occlusion in aged persons
Region
| Japan |
Condition
Condition
ageing
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyse the characteristics of the craniofacial skeletal patterns of elderly persons with a stable occlusal relationship.
Basic objectives2
Others
Basic objectives -Others
To analyse the potential application of normal skeletal data to patients with loss of occlusion.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Saddle angle
2. Articular angle
3. Gonial angle
4. Anterior Facial Height (AFH)
5. Posterior Facial Height (PFH)
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 70 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Cases where the age at the time of dental panoramic X-ray and cephalogram examination is 70 years or older.
2. Cases with 26 to 28 remaining teeth.
3. Patients who have given their free and voluntary consent to participate in the study or who do not refuse to participate in the study.
Key exclusion criteria
1. Cases where dental implants have been placed.
2. Cases with more than 3 missing teeth in the molar region.
3. Cases with periodontal pockets exceeding 4mm in periodontal pocket examination.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Minowa |
| Middle name | |
| Last name | Kazuyuki |
Organization
Hokkaido university Department of Dental Medicine
Division name
Radiology
Zip code
0608586
Address
Kita 13, Nishi 7, Kita-ku, Sapporo
TEL
0117064295
kminowa@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Yamano |
Organization
Hokkaido university Department of Dental Medicine
Division name
Radiology
Zip code
0608586
Address
Kita 13, Nishi 7, Kita-ku, Sapporo
TEL
0117064295
Homepage URL
yamanomo@den.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido university
Institute
Department
Personal name
Funding Source
Organization
Hokkaido university
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
Tel
0117067636
crjimu@huhp.hokudai.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
| 2023 | Year | 03 | Month | 31 | 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
15
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
| 2022 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No observations are made on the subject
Management information
Registered date
| 2023 | Year | 03 | Month | 01 | Day |
Last modified on
| 2023 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057470
