UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061400 |
|---|---|
| Receipt number | R000070255 |
| Scientific Title | Association Between Glycemic Measures and Periodontal Parameters in Patients with Periodontal Disease Attending Dental Clinics: Detection of Impaired Glucose Tolerance Using Blood Glucose and HbA1c |
| Date of disclosure of the study information | 2026/04/28 |
| Last modified on | 2026/04/28 12:10:54 |
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Basic information
Public title
Association Between Glycemic Measures and Periodontal Parameters in Patients with Periodontal Disease Attending Dental Clinics: Detection of Impaired Glucose Tolerance Using Blood Glucose and HbA1c
Acronym
Detection of Impaired Glucose Tolerance Using Blood Glucose and HbA1c Measurements in Dental Clinics and Its Association with Periodontal Parameters
Scientific Title
Association Between Glycemic Measures and Periodontal Parameters in Patients with Periodontal Disease Attending Dental Clinics: Detection of Impaired Glucose Tolerance Using Blood Glucose and HbA1c
Scientific Title:Acronym
Association Between Glycemic Measures and Periodontal Parameters in Patients with Periodontal Disease Attending Dental Clinics: Detection of Impaired Glucose Tolerance Using Blood Glucose and HbA1c
Region
| Japan |
Condition
Condition
periodontal disease
Classification by specialty
| Endocrinology and Metabolism | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to assess whether the presence or absence of impaired glucose tolerance is associated with periodontal disease-related clinical parameters in patients with periodontal disease attending dental clinics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in mean PISA and PESA values between patients with and without impaired glucose tolerance
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
This study will include individuals who meet all of the following criteria:
1. Individuals aged 30 years or older.
2. Individuals requiring periodontal disease treatment.
Key exclusion criteria
(3) Exclusion criteria
Individuals who meet any of the following criteria will be excluded from this study:
Individuals whom the investigator judges to be inappropriate for participation in this study, including those who meet any of the following conditions:
a. Individuals who are already receiving treatment for diabetes.
b. Individuals for whom periodontal examinations or blood glucose/HbA1c measurements cannot be safely performed due to severe systemic disease or acute illness.
c. Individuals who are expected to have difficulty attending visits or undergoing examinations during the observation period, such as those planning to relocate or those with difficulty attending the clinic.
d. Individuals with special oral conditions that are considered to affect the conduct of the study, such as after extensive jawbone resection or cases in which PISA/PESA measurements are not possible due to denture use.
e. Individuals for whom continuation of the study is judged to be difficult for other medical or ethical reasons.
Individuals who do not provide consent to participate in this study.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Kensaku |
| Middle name | |
| Last name | Fukunaga |
Organization
Kagawa university
Division name
Department of Endocrinology and Metabolism, Faculty of Medicine
Zip code
761-0793
Address
1750-1, Ikenobe, Miki-cho, Kita-gun
TEL
0878912230
fukunaga.kensaku@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | kensaku |
| Middle name | |
| Last name | fukunaga |
Organization
Kagawa university
Division name
Department of Endocrinology and Metabolism
Zip code
761-0793
Address
1750-1, Miki-cho
TEL
0878985111
Homepage URL
fukunaga.kensaku@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa university
Institute
Department
Personal name
kensaku fukunaga
Funding Source
Organization
none
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
Ethics Committee, Faculty of Medicine, Kagawa University
Address
1750-1, Miki-cho
Tel
0878985111
fukunaga.kensaku@kagawa-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
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Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 28 | 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
| 2025 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to evaluate the association between impaired glucose tolerance status and periodontal disease-related clinical parameters in patients with periodontal disease attending dental clinics.
Management information
Registered date
| 2026 | Year | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070255
