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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021564
Receipt No. R000024860
Scientific Title Implementation and evaluation of a periodontal disease care program for patients with type 2 diabetes
Date of disclosure of the study information 2016/04/01
Last modified on 2016/03/22

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Basic information
Public title Implementation and evaluation of a periodontal disease care program for patients with type 2 diabetes
Acronym a randomized controlled trial
Scientific Title Implementation and evaluation of a periodontal disease care program for patients with type 2 diabetes
Scientific Title:Acronym a randomized controlled trial
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism Dental medicine Nursing
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to administer a periodontal disease care program to patients with type 2 diabetes and to evaluate its effectiveness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes bleeding on probing (BOP)
tests at baseline and at 6 months
Key secondary outcomes probing pocket depth (PPD)
Self-Efficacy Scale for Self-care (SESS)
Hiroshima University Dental Health Behavioral Inventory (HU-DBI)
HbA1c
the tests at baseline and at 6 months

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 We created a 120-min program for the intervention group that spanned 6 months and was presented in four sessions, with 6-8-week intervals between each session. In addition to the information and guidance about treatment that patients routinely receive from the diabetes clinic and the OMS Department and the standard dental health instructions from the dental hygienists, the intervention group received information about the relationship between diabetes and periodontal disease, and they learnt how to administer selfcare for their periodontal disease.
Interventions/Control_2 The participants in the control group underwent diabetes checks at the clinic and received guidance about treatment, which they would receive routinely. The control participants also underwent examinations at the OMS Department, which were followed by routine dental health instruction.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria The participants were selected from adult outpatients who were receiving care for type 2 diabetes, had received a diagnosis of periodontal disease from the Oral and Maxillofacial Surgery (OMS) Department, and were deemed capable of administering self-care. From these individuals, we selected subjects whose HbA1c levels were 6.5-10% with fluctuations of1.0%, 9-15 weeks before they registered to participate in the study, who were not edentulous, and who had mild-to-medium levels of periodontal disease that did not require treatment with antibiotics.
Key exclusion criteria The exclusion criteria were concurrent conditions that could influence the diabetic condition, which included cancer, subjects who used steroids, and individuals with diseases that required surgery that would create external wounds.
Target sample size 66

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name UTAKO NISHIHARA
Organization Graduate School of Nursing Osaka City University
Division name Nursing
Zip code
Address , 1-5-17 Asahi Abeno, Osaka 545-0051, Japan
TEL 06-6645-3511
Email uta.sakura.pinkuiro@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name UTAKO NISHIHARA
Organization Graduate School of Nursing Osaka City University
Division name Nursing
Zip code
Address 1-5-17 Asahi Abeno, Osaka 545-0051, Japan
TEL 06-6645-3511
Homepage URL
Email uta.sakura.oinkuiro@gmail.com

Sponsor
Institute Graduate School of Nursing Osaka City University
Institute
Department

Funding Source
Organization no founding
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
2016 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
2013 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 22 Day
Last modified on
2016 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024860

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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