UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026807 |
|---|---|
| Receipt number | R000030778 |
| Scientific Title | Creation and validation of effective questionnaire for periodontitis screening for medical dental collaboration for diabetic patients - Preliminary study - |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2023/04/14 17:20:07 |
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Basic information
Public title
Creation and validation of effective questionnaire for periodontitis screening for medical dental collaboration for diabetic patients - Preliminary study -
Acronym
Creation questionnaire for periodontitis screening for diabetic patients
Scientific Title
Creation and validation of effective questionnaire for periodontitis screening for medical dental collaboration for diabetic patients - Preliminary study -
Scientific Title:Acronym
Creation questionnaire for periodontitis screening for diabetic patients
Region
| Japan |
Condition
Condition
periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Periodontal disease and diabetes are related to each other. In order for the physician to effectively recommend a dental visit to the patient, it is desirable that there is an index for predicting the patient's periodontal disease morbidity and chewing ability. In this study, we prepared a questionnaire for patients to predict the periodontal disease morbidity and chewing ability, compare it with actual periodontal tissue examination and chewing ability test results, and examined the usefulness of periodontal disease screening effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Periodontal tissue examination (PPD, BOP, degree of mobility, X-ray ), chewing ability test and answer to questionnaire
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
An adult patient who visited Tohoku University Hospital's periodontitis department and was diagnosed with moderate to severe periodontitis. There is no problem in gender. The severity of periodontitis is classified based on clinical indicators shown below.
(Clinical indicator of severity of periodontitis):
Healthy moderate degree of periodontitis Severe periodontitis
(Destruction of periodontal tissue) None 1/3 to 1/2 1/2 or more
(Attachment loss) None 4 to 6 mm 7 mm or more
(Degree of alveolar bone resorption) None root length 1/3 to 1/2 root length 1/3 or more
(Extent of bifurcation lesion) None Mild Class 2 or more
(Tooth oscillation) No Yes, about 1 degree, 2 degrees or more
Also, ask a person who gained informed consent as a comparative control group to cooperate. Specifically, the following three target groups are set.
Target Group 1: Tohoku University Hospital Patients who underwent periodontal therapy who have been diagnosed with moderate to severe periodontitis after seeing the department of periodontal disease, currently undergoing maintenance treatment
Target Group 2: Tohoku University Hospital Patients who have undergone periodontal disease examination, are diagnosed with moderate to severe periodontitis, and start periodontal treatment from now
Target Group 3: Person who got informed consent and does not have periodontal disease
Key exclusion criteria
Those who can not obtain informed consent for this research
Persons whose memory of the situation at the time of first visit is unknown in periodontal disease maintenance treatment group
Other persons who judged that it is inappropriate as the subject of the research by the person responsible for the implementation or the research sharing person
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Nemoto |
Organization
Tohoku University Graduate School of Dentistry
Division name
Department of Periodontology and Endodontology
Zip code
Address
4-1, Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-8334
e-nemoto@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Nemoto |
Organization
Tohoku University Graduate School of Dentistry
Division name
Department of Periodontology and Endodontology
Zip code
Address
4-1, Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-8334
Homepage URL
e-nemoto@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Dentistry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 04 | Month | 01 | 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
| 2017 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Since this research is a position as a pilot study, we set the number of cases that can be taken at each divisional facility.
Management information
Registered date
| 2017 | Year | 03 | Month | 31 | Day |
Last modified on
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030778
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
