UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of the effects of oral hygiene instruction and periodontal treatment on patients with Type 2 diabetes mellitus
Acronym	Oral hygiene instruction and periodontal treatment for diabetic patients
Scientific Title	Comparison of the effects of oral hygiene instruction and periodontal treatment on patients with Type 2 diabetes mellitus
Scientific Title:Acronym	Oral hygiene instruction and periodontal treatment for diabetic patients
Region	Japan

Condition
Condition	Diabetes Mellitus, Periodontital disease
Classification by specialty	Endocrinology and Metabolism Nephrology Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the HbA1c level between the subjects who received oral hygiene instruction only and non-surgical periodontal treatment
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	glycated hemoglobin (HbA1c)
Key secondary outcomes	fasting plasma glucose, glicated albumin, creatinine, cytokines, oxidative stress, and QOL

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Non-surgical periodontal treatment
Interventions/Control_2	Oral hygiene 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	30 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Type 2 diabetic patients Capable of participating in the study for 6 months Supported by medical insurance 30 years or older at the onset of study Consenting patients Outpatient
Key exclusion criteria	Undergoing dental treatment Under pregnancy Being diagnosed as unsuitable subjects
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Manabu Morita
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Preventive Dentistry
Zip code
Address	Shikata-cho 2-5-1, Okayama 700-8558
TEL	086-235-6710
Email	mmorita@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Manabu Morita
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Preventive Dentistry
Zip code
Address	Shikata-cho 2-5-1, Okayama 700-8558
TEL	086-235-6710
Homepage URL
Email	mmorita@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	Ministry of Health, labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	2014 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	Forty participants were enrolled. The periodontal treatment group (n = 20) received non-surgical periodontal therapy. The control group (n = 17) received only oral hygiene instructions. Changes in HbA1c in the periodontal treatment group were not significantly different with those in the control group at 3 and 6 months. Mean probing pocket depth, clinical attachment level, systemic oxidative stress balance and QOL significantly improved in the periodontal treatment group compared to the control group at 3 months. In the subgroup analysis (moderately poor control of diabetes), the decrease in HbA1c levels in the periodontal treatment group was significantly greater than that in the control group at 3 months.
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	2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2016 Year 08 Month 31 Day
Date of closure to data entry	2016 Year 09 Month 30 Day
Date trial data considered complete	2016 Year 09 Month 30 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 02 Month 26 Day
Last modified on	2018 Year 03 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015478

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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