UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006693 |
|---|---|
| Receipt number | 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 20:36:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007912
