UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041079 |
|---|---|
| Receipt number | R000046909 |
| Scientific Title | Retrospective Study for factors impacting on the final outcomes of alveolar bone grafting evaluated in adulthood. |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2023/07/17 10:31:00 |
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Basic information
Public title
Retrospective Study for factors impacting on the final outcomes of alveolar bone grafting evaluated in adulthood.
Acronym
Retrospective Study for factors impacting on the final outcomes of alveolar bone grafting evaluated in adulthood.
Scientific Title
Retrospective Study for factors impacting on the final outcomes of alveolar bone grafting evaluated in adulthood.
Scientific Title:Acronym
Retrospective Study for factors impacting on the final outcomes of alveolar bone grafting evaluated in adulthood.
Region
| Japan |
Condition
Condition
cleft lip and or palate
Classification by specialty
| Plastic surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the factors impacting on the X-ray evaluation of alveolar bone in the permanent dentition with CT evaluation just after the bone graft, orthodontic works and the other factors associated with the patient.
Basic objectives2
Others
Basic objectives -Others
To investigate the factors that influence the alveolar height of the bone graft in the permanent dentition of patients with alveolar bone grafting.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
"Bergrand evaluation of alveolus by dental Xp before the final orthodontic treatment" and "Bergrand evaluation by dental Xp after the final orthodontic treatment"
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The objects of this study are patients aged 20 years or older at the date of March 31, 2019, who underwent alveolar bone grafting during the primary or mixed dentition stage at Plastic and Reconstructive Surgery in Tohoku University Hospital. In addition, the objects are underwent continuous oral care at the Clinics for Maxillo-Oral Disorders in the dental center of Tohoku University Hospital.
Key exclusion criteria
Cases where medical records such as CT and X-ray are not available. Cases that include conditions other than CT findings in the decision of CT evaluation and cases that have complications due to factors that are not related to surgery or tooth status, such as failure to observe postoperative dietary restrictions, will also be excluded from the target.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoshimichi |
| Middle name | |
| Last name | imai |
Organization
Tohoku University, School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
9808575
Address
2-1, Seiryou-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7332
yo-imai@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimichi |
| Middle name | |
| Last name | Imai |
Organization
Tohoku University, School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
980-8575
Address
2-1, Seiryou-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7332
Homepage URL
yo-imai@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku University Graduate school of Dentistry, Clinics for Orthodontics and Speech Therapy for Craniofacial Anomalies
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University School of Medicine
Address
2-1, Seiryou-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-728-4105
rinri-2@proj.med.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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 01 | 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
100
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The reviewers instructed us to make a major change in the analysis method.
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
The medical informations were acquired in a retrospective review of medical and dental records.
Management information
Registered date
| 2020 | Year | 07 | Month | 12 | Day |
Last modified on
| 2023 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046909
