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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016561
Receipt No. R000019217
Scientific Title Assessment of the evaluating method for a spontaneous healing process at the extracted socket
Date of disclosure of the study information 2015/02/17
Last modified on 2015/02/17

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Basic information
Public title Assessment of the evaluating method for a spontaneous healing process at the extracted socket
Acronym Assessment of the evaluating method for a spontaneous healing process at the extracted socket
Scientific Title Assessment of the evaluating method for a spontaneous healing process at the extracted socket
Scientific Title:Acronym Assessment of the evaluating method for a spontaneous healing process at the extracted socket
Region
Japan

Condition
Condition Patient whose dental extraction is planned
Classification by specialty
Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In patients whose dental extraction is planned, the post-operative changes will be evaluated during the spontaneous healing process at the extracted socket, in terms of the bone density ratio of newly generated bone and the radiological observations.
Basic objectives2 Others
Basic objectives -Others Evaluation of post-operative changes in the bone density ratio of newly generated bone and the radiological observations
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1 The bone density ratio
2 Radiological evaluation
Key secondary outcomes 1 Height of alveolar bone
2 Width of alveolar bone

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
50 years-old >
Gender Male and Female
Key inclusion criteria Patient:
1)whose extraction site is either one of between incisor and second premolar or mandibular third molars
2)with remaining dental root more than half at the extraction site
3)whose extracted socket would be possibly fulfilled with the bone
4)who has sufficient keratinized gingiva to cover the extracted socket
5)with a prior written consent
6)who is 20 years and older, and younger than 50 years at the time of consent
7)who can maintain a good oral hygiene condition during the follow-up term
Key exclusion criteria 1)Issues affecting evaluation of safety
Patient:
1 with traumatic bone defect
2 whose surgical treatment (GBR, implant, etc) is planned in 24 weeks after the extraction, or has been done in 24 weeks before, in the same jaw where the extraction is planned
3 with untreated severe periodontal disease or caries (moderate or severe in adult periodontitis, or C4 grade in caries)
2)Issues affecting patient safety
Patient:
1 who was regularly smoking till 24 weeks before the extraction, or will possibly smoke during the follow-up term
2 of diabetes not under control
3 who has had an irradiation record at head and neck region
4 with severe metabolic bone disease (osteoporosis, osteomalacia, rachitis, etc)
5 who took drugs affecting bone metabolism (bis-phosphonate, calcitonine, etc)
3)Issues affecting evaluation of efficacy
Patient:
1 who has an implant adjacent to the extraction site
2 whose teeth adjacent to the extraction site has a metal nail (screw post)
3 whose teeth adjacent to the extraction site has a metal prosthesis fully covering the crown down to alveolar bone
4 having metal subjects that might cause artifact in CT image up to the same level as extracted alveolar bone
4)General consideration
Patient:
1 who has a history of infection disease, or is in danger of it
2 in pregnancy or of possible pregnancy, or seeking pregnant, or during breast-feeding
3 who has a history of autoimmune diseases
4 in unstable or fatal in clinical condition (that might require urgent treatment)
5 with clinically serious organ disorder (heart failure of NYHA Class IV, arrhythmia such as ventricle tachycardia, fibrillation and flutter, adult respiratory distress syndrome, and for kidney, blood, metabolic/electrolyte abnormality and circulatory, in grade 3 defined in the 80th notification by MHW issued on June 29, 1992.
6 who was using a investigational device or drugs within one year before participating this study
7 who was judged disqualified as the subject by a principal investigator or sub-investigators
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Kakudo
Organization Osaka Dental University
Division name Second Department of Oral and Maxillofacial Surgery
Zip code
Address 1-5-17 Otemae, Chuo-Ku, Osaka
TEL 06-6910-1076
Email kakudo@cc.osaka-dent.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Kakudo
Organization Osaka Dental University
Division name Second Department of Oral and Maxillofacial Surgery
Zip code
Address 1-5-17 Otemae, Chuo-Ku, Osaka
TEL 06-6910-1076
Homepage URL
Email kakudo@cc.osaka-dent.ac.jp

Sponsor
Institute Osaka Dental University
Institute
Department

Funding Source
Organization KYOCERA Medical Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大阪歯科大学附属病院(大阪府) Osaka Dental University Hospital
神奈川歯科大学附属病院(神奈川県)Kanagawa Dental University Hospital
鶴見大学歯学部(神奈川県) Tsurumi University School of Dental Medicine

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 17 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 Completed
Date of protocol fixation
2007 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2015 Year 02 Month 17 Day
Last modified on
2015 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019217

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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