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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041079
Receipt No. 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 2020/07/12

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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
Email 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
Email yo-imai@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2023 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
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
2020 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046909

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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