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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026807
Receipt No. 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 2017/03/31

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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
Email 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
Email e-nemoto@dent.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Dentistry
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2017 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 04 Day
Last follow-up date
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
2017 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030778

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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