UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039672 |
|---|---|
| Receipt number | R000045252 |
| Scientific Title | Association between periodontitis and diabetes/prediabetes, and alteration of diabetes markers due to initial periodontal treatment |
| Date of disclosure of the study information | 2020/03/03 |
| Last modified on | 2024/06/04 16:46:02 |
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Basic information
Public title
Alteration of diabetes markers due to periodontal treatment
Acronym
Periodontitis and diabetes markers
Scientific Title
Association between periodontitis and diabetes/prediabetes, and alteration of diabetes markers due to initial periodontal treatment
Scientific Title:Acronym
Alteration of diabetes markers due to initial periodontal treatment
Region
| Japan |
Condition
Condition
Chronic periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate alteration of diabetes markers due to initial periodontal treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Alteration 10-12 weeks after treatment
- hemoglobin A1c
- High-sensitive CRP in serum
- Blood glucose
Key secondary outcomes
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Moderate to severe chronic periodontitis
patients over the age of 30 years
2.Possessed a minimum of 20 teeth
Key exclusion criteria
1.Persons who had received scaling and root
planing within the previous 6 months
2.Persons who had taken systemic
antibiotics or anti-inflammatory drugs
within 3 months before experiment
3.Persons who had severe systemic diseases
4.Smoker
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshiya |
| Middle name | |
| Last name | Morozumi |
Organization
Kanagawa Dental University Graduate School of Dentistry
Division name
Division of Periodontology, Department of Oral Interdisciplinary Medicine
Zip code
238-8580
Address
82 Inaoka-Cho, Yokosuka 238-8580
TEL
0468228855
morozumi@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Toshiya |
| Middle name | |
| Last name | Morozumi |
Organization
Kanagawa Dental University Graduate School of Dentistry
Division name
Division of Periodontology, Department of Oral Interdisciplinary Medicine
Zip code
238-8580
Address
82 Inaoka-Cho, Yokosuka 238-8580
TEL
0468228855
Homepage URL
morozumi@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Arkray Marketing,Inc.
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
Research ethics committee, the Japanese Society of Periodontology
Address
Komagome TS building 4F, Komagome 1-43-9, Toshima-Ku, Tokyo
Tel
03-3947-8891
gakkai16@kokuhoken.or.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
大船駅北口歯科（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 03 | 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
| 2019 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Samples are taken from fingertip (minimal invasion).
Management information
Registered date
| 2020 | Year | 03 | Month | 03 | Day |
Last modified on
| 2024 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045252
