UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023395 |
|---|---|
| Receipt number | R000026957 |
| Scientific Title | Effectiveness of periodontal health improvement on vascular endothelial function: a randomized clinical trial |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2021/09/29 13:59:49 |
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Basic information
Public title
Effectiveness of periodontal health improvement on vascular endothelial function: a randomized clinical trial
Acronym
Assessment of vascular endothelial function in patients receiving periodontal treatment.
Scientific Title
Effectiveness of periodontal health improvement on vascular endothelial function: a randomized clinical trial
Scientific Title:Acronym
Assessment of vascular endothelial function in patients receiving periodontal treatment.
Region
| Japan |
Condition
Condition
Odontogenic bacteremia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of causal relationship between periodontal health improvement and vascular endothelial function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in arterial flow mediated dilation between before and after 90 days of intervention.
Key secondary outcomes
Changes in periodontal parameters, blood pressure, body composition, level of fatigue, serum levels of ADMA, CRP, IL-6, glucocorticoid and IL-8, salivary levels of amylase and glucocorticoid, and major oral pathogens between before and after 90 days of intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Application of dilute sodium hypochlorite super-oxidized water to periodontal tissue (including pocket region) by using dental custom tray twice a day for 90 days after initial preparation.
Interventions/Control_2
Initial preparation.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Those who agreed to participate in the study with written informed consent.
2. Those who have 20 or more functioning teeth.
3. Those who have periodontitis with bleeding on probing (more than two sites) and/or with 4 mm or larger pocket (more than one site).
Key exclusion criteria
1. Those who are unable to travel to the institutions by themselves.
2. Those who need periodontal surgery.
3. Those who need prosthodontic treatment.
4. Those who have untreated cavity.
5. Those who have semi-impacted tooth (one or more).
6. Those who have undergone an antibiotic therapy within 3 months before the start of study.
7. Those who need to be medicated routinely (except for supplements such as vitamins).
8. Those who might (or will) need any other treatment in high-priority than periodontal treatment.
9. Those who are participating in another clinical trial.
10. Those who were or will be judged inappropriate by the principal investigator.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Hanada |
Organization
Tsurumi University
Division name
School of Dental Medicine
Zip code
230-8501
Address
2-1-3 Tsurumi Yokohama, Japan
TEL
0455808462
hanada-n@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Meu |
| Middle name | |
| Last name | Ariyoshi |
Organization
Tsurumi University
Division name
School of Dental Medicine
Zip code
230-8501
Address
2-1-3 Tsurumi Yokohama, Japan
TEL
0455808462
Homepage URL
ishikawa-me@tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi University School of Dental Medicine, Department of Translational Research
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Tsurumi University School of Dental Medicine
Address
2-1-3 Tsurumi, Yokohama
Tel
0455808317
kyoken@tsurumi-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
鶴見大学歯学部附属病院（神奈川県）、医療法人社団きらり紀尾井町プラザクリニック（東京都）、医療法人社団有生会有吉歯科（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1371/journal.pone.0257247.s002
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1371/journal.pone.0257247
Number of participants that the trial has enrolled
110
Results
Periodontal care for a 3-month duration did not provide better endothelial function although improvements of periodontal status in patients with early-stage periodontal diseases.
Results date posted
| 2021 | Year | 09 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 09 | Month | 23 | Day |
Baseline Characteristics
The baseline characteristics of the patients were similar between the groups.
Participant flow
Fifty-six and 54 patients were allocated to control and test group, respectively.
Five patients became lost to follow-up in each group.
ITT analysis (control: n=56, test: n=54) and PP analysis (control: n=49, Test: n=41) were performed.
Adverse events
none
Outcome measures
Primary: flow-mediated brachial artery dilatation Secondary: serum asymmetric dimethylarginine level
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 20 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 29 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 29 | Day |
Last modified on
| 2021 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026957
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/08/11 | 研究計画書.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/08/11 | カルテ.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/04/07 | FMD Data.xlsx |
