UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013278 |
|---|---|
| Receipt number | 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 08:03:32 |
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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
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
mmorita@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015478
