UMIN-CTR Clinical Trial

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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