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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006693
Receipt No. R000007912
Scientific Title Study of glycemic control after periodontal treatment by resolving gingival inflammation in type 2 diabetic patients with periodontal disease
Date of disclosure of the study information 2011/11/08
Last modified on 2011/11/08

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Basic information
Public title Study of glycemic control after periodontal treatment by resolving gingival inflammation in type 2 diabetic patients with periodontal disease
Acronym Study of glycemic control after periodontal treatment in type 2 diabetic patients
Scientific Title Study of glycemic control after periodontal treatment by resolving gingival inflammation in type 2 diabetic patients with periodontal disease
Scientific Title:Acronym Study of glycemic control after periodontal treatment in type 2 diabetic patients
Region
Japan

Condition
Condition type 2 diabetic patients with periodontal disease
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The
purpose of this study was to examine the effects of a non-surgical periodontal
treatment incorporating topical antibiotics on glycemic control and serum
inflammatory mediators in patients with type 2 diabetes mellitus with periodontitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Glycated hemoglobin (HbA1c), hs-CRP, TNF-alpha and IL-6 level after periodontal treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 All the patients underwent an initial examination including a general medical history
and complete full-mouth periapical radiographs (bisecting angle projections). At the
second and third visits, we instructed the patients in oral hygiene methods (tooth
brushing, inter-dental brushing and/or dental flossing) and removed supragingival
plaque and calculus using an ultrasonic scaler (Varios, Nakanishi Inc, Japan). At the
fourth and fifth visits, subgingival scaling and root planing was performed to remove
plaque and calculus using the same device. On the second to fifth visits, 10 mg of local
minocycline ointment (Periofil®; Showa Yakuhin, Tokyo, Japan) were applied to each
periodontal pocket after treatment. The maximum duration between the second visit
and the fifth visit was 2 months.
Interventions/Control_2
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
35 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria HbA1c level, 6.2-10.4%
Key exclusion criteria severe diabetic complications
evidence of systemic disease other than diabetes as a risk factor for periodontitis
administration of systemic antibiotics during the preceding 3 months
pregnancy or lactation
allergy to tetracycline
modifications to the treatment received for diabetes during the preceding 2 months
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Izumi
Organization Tokyo Medical and Dental University
Division name Periodontology
Zip code
Address 1-5-45, Yushima, BUnkyo-ku,Tokyo, Japan
TEL 03-5803-5488
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sayaka Katagiri
Organization Tokyo Medical and Dental University
Division name Periodontology
Zip code
Address
TEL 03-5803-5488
Homepage URL
Email

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
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
2011 Year 11 Month 08 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
2008 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 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
2011 Year 11 Month 08 Day
Last modified on
2011 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007912

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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