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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013278
Receipt No. R000015478
Scientific Title Comparison of the effects of oral hygiene instruction and periodontal treatment on patients with Type 2 diabetes mellitus
Date of disclosure of the study information 2014/04/01
Last modified on 2018/03/02

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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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