UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016561 |
|---|---|
| Receipt number | 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 14:34:36 |
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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
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
kakudo@cc.osaka-dent.ac.jp
Sponsor or person
Institute
Osaka Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019217
