UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036983 |
|---|---|
| Receipt number | R000042132 |
| Scientific Title | Research about novel tooth brushing instruction following degree of periodontal distraction: a randamized clinical trial |
| Date of disclosure of the study information | 2019/06/30 |
| Last modified on | 2022/12/14 11:29:41 |
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Basic information
Public title
Effective tooth brushing instruction focusing on deep periodontal pockets
Acronym
Effective tooth brushing instruction
Scientific Title
Research about novel tooth brushing instruction following degree of periodontal distraction: a randamized clinical trial
Scientific Title:Acronym
Novel tooth brushing instruction
Region
| Japan |
Condition
Condition
periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare conventional tooth brushing instruction with novel tooth brushing instruction that focusing on deep periodontal pockets, and to estimate for the effect with improvement of periodontal tissue
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Periodontal Inflamed Surface Area after 4th time tooth brushing instruction in 4 month
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
4th time conventional tooth brushing instruction in 4 month
Interventions/Control_2
4th time novel tooth brushing instruction in 4 month
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
1 pervasive moderate or sever periodontitis ratio of PD over 4 was more than 30 percent
2 having over 20 teeth
Key exclusion criteria
1 use of antibiotics within the preceding three months
2 cognitive impairment
3 gingival hyperplasia due to use of immunosuppressive drugs or calcium channel blockers
4 hereditary gingival fibromatosis
5 OLeary PCR less than 30 percent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Aino |
Organization
School of Dentistry, Aichi Gakuin University
Division name
Department of Periodontology
Zip code
464-8651
Address
Nagoya, Aichi 464-8651, Japan
TEL
052-759-2111
i-makoto@dpc.agu.ac.jp
Public contact
Name of contact person
| 1st name | Takato |
| Middle name | |
| Last name | Matsuura |
Organization
School of Dentistry, Aichi Gakuin University
Division name
Department of Periodontology
Zip code
464-8651
Address
Nagoya, Aichi 464-8651, Japan
TEL
052-759-2111
Homepage URL
mtakato@dpc.agu.ac.jp
Sponsor or person
Institute
Aichi gakuin university
Institute
Department
Personal name
Funding Source
Organization
Aichi gakuin 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
School of Dentistry, Aichi Gakuin University
Address
Nagoya, Aichi 464-8651, Japan
Tel
052-759-2111
mtakato@dpc.agu.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
| 2019 | Year | 06 | 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
| Delay expected |
Results Delay Reason
It took time to analyze the data.
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
| 2015 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 06 | Day |
Last modified on
| 2022 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042132
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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