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

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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 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


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

Value
https://center6.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