UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022347 |
|---|---|
| Receipt number | R000025760 |
| Scientific Title | The evaluation of clinical outcomes and patient-reported outcomes following treatment of intrabony defects using a natural bone mineral and GTR |
| Date of disclosure of the study information | 2016/05/30 |
| Last modified on | 2017/12/07 12:09:23 |
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Basic information
Public title
The evaluation of clinical outcomes and patient-reported outcomes following treatment of intrabony defects using a natural bone mineral and GTR
Acronym
The evaluation of intrabony defects treatment using a natural bone mineral and GTR
Scientific Title
The evaluation of clinical outcomes and patient-reported outcomes following treatment of intrabony defects using a natural bone mineral and GTR
Scientific Title:Acronym
The evaluation of intrabony defects treatment using a natural bone mineral and GTR
Region
| Japan |
Condition
Condition
periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the clinical outcomes and patient-reported outcomes following treatment of intrabony defects with application of a natural bone mineral (Bio-Oss) and guided tissue regeneration (Bio-Gide) compared with autograft and Bio-Gide. Using Bio-Oss has the advantage in both patient-related outcome and operation time, since the clinical outcome is comparable to using autograft.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical attachment level(6 month 12 month)
Key secondary outcomes
patient-related outcome
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A natural bone mineral (Bio-Oss) and guided tissue regeneration (Bio-Gide)
Interventions/Control_2
Autograft and guided tissue regeneration (Bio-Gide)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
intrabony defect
PPD: Probing pocket depth over 6mm.
Radiographic evidence of an intrabony component over 4mm.
Key exclusion criteria
(1) Systemic disease that could influence the outcome of therapy.
(2) Systemic antibiotics had been used within at least 3 months.
(3) Smokers.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Izumi Yuichi |
Organization
Tokyo Medical and Dental University
Division name
Department of Periodontology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5488
y-izumi.peri@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hoshi Shu |
Organization
Tokyo Medical and Dental University
Division name
Department of Periodontology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5488
Homepage URL
hosperi@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental 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
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | 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
Management information
Registered date
| 2016 | Year | 05 | Month | 18 | Day |
Last modified on
| 2017 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025760
