UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011709 |
|---|---|
| Receipt number | R000013691 |
| Scientific Title | Effects of collagen membrane for combination therapies with regenerative materials of enamel matrix derivative and xenogeneic bone graft for periodontal surgery. |
| Date of disclosure of the study information | 2013/09/11 |
| Last modified on | 2023/09/19 11:51:48 |
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Basic information
Public title
Effects of collagen membrane for combination therapies with regenerative materials of enamel matrix derivative and xenogeneic bone graft for periodontal surgery.
Acronym
Combination therapies with EMD, xenogeneic bone and collagen membrane.
Scientific Title
Effects of collagen membrane for combination therapies with regenerative materials of enamel matrix derivative and xenogeneic bone graft for periodontal surgery.
Scientific Title:Acronym
Combination therapies with EMD, xenogeneic bone and collagen membrane.
Region
| Japan |
Condition
Condition
Periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of collagen membrane for combination therapies with regenerative materials of enamel matrix derivative and xenogeneic bone graft for periodontal surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) bone level
2) clinical attachment level
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
In periodontal tissue regeneration procedure, after the root surface debridement, Enamel Matrix Derivative is applied on the root surface and deproteinized bovine bone matrix is filled in bone defect. Then, collagen membrane is placed to cover them and sutured.
Interventions/Control_2
In periodontal tissue regeneration procedure, after the root surface debridement enamel matrix derivative is applied on the root surface and deproteinized bovine bone matrix was filled in bone defect. And the wound was sutured.
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with periodontitis accompanied with proving pocket depth more than 6mm deep and vertical infra bony defect after initial periodontal therapy, are selected.
Key exclusion criteria
Patients with following conditions are excluded from subjects: patients with pre-existing severe diseases such as diabetes mellitus, cardiovascular disease and autoimmune disease etc.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Yoshie |
Organization
Niigata University
Division name
Division of Periodontology
Zip code
951-8514
Address
2-5274 Gakkocho-Dori, Chuo-ku, Niigata, 951-8514 Japan
TEL
+81252272869
yoshie@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Nemoto |
Organization
Niigata University
Division name
Division of Periodontology
Zip code
951-8514
Address
2-5274 Gakkocho-Dori, Chuo-ku, Niigata, 951-8514 Japan
TEL
+8125227871
Homepage URL
yasuko@kyi.biglobe.ne.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata University
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
Niigata University Medical and Dental Hospital
Address
1-757, Asahimachi-Dori, Chuo-ku, Niigata
Tel
025-227-2871
kubota@dent.niigata-u.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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
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
| 2013 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 11 | Day |
Last modified on
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013691
