UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021564
Receipt number R000024860
Scientific Title Implementation and evaluation of a periodontal disease care program for patients with type 2 diabetes
Date of disclosure of the study information 2016/04/01
Last modified on 2016/03/22 16:58:07

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Basic information

Public title

Implementation and evaluation of a periodontal disease care program for patients with type 2 diabetes

Acronym

a randomized controlled trial

Scientific Title

Implementation and evaluation of a periodontal disease care program for patients with type 2 diabetes

Scientific Title:Acronym

a randomized controlled trial

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism Dental medicine Nursing
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to administer a periodontal disease care program to patients with type 2 diabetes and to evaluate its effectiveness.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

bleeding on probing (BOP)
tests at baseline and at 6 months

Key secondary outcomes

probing pocket depth (PPD)
Self-Efficacy Scale for Self-care (SESS)
Hiroshima University Dental Health Behavioral Inventory (HU-DBI)
HbA1c
the tests at baseline and at 6 months


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation


Institution consideration


Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

We created a 120-min program for the intervention group that spanned 6 months and was presented in four sessions, with 6-8-week intervals between each session. In addition to the information and guidance about treatment that patients routinely receive from the diabetes clinic and the OMS Department and the standard dental health instructions from the dental hygienists, the intervention group received information about the relationship between diabetes and periodontal disease, and they learnt how to administer selfcare for their periodontal disease.

Interventions/Control_2

The participants in the control group underwent diabetes checks at the clinic and received guidance about treatment, which they would receive routinely. The control participants also underwent examinations at the OMS Department, which were followed by routine dental health 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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

The participants were selected from adult outpatients who were receiving care for type 2 diabetes, had received a diagnosis of periodontal disease from the Oral and Maxillofacial Surgery (OMS) Department, and were deemed capable of administering self-care. From these individuals, we selected subjects whose HbA1c levels were 6.5-10% with fluctuations of1.0%, 9-15 weeks before they registered to participate in the study, who were not edentulous, and who had mild-to-medium levels of periodontal disease that did not require treatment with antibiotics.

Key exclusion criteria

The exclusion criteria were concurrent conditions that could influence the diabetic condition, which included cancer, subjects who used steroids, and individuals with diseases that required surgery that would create external wounds.

Target sample size

66


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name UTAKO NISHIHARA

Organization

Graduate School of Nursing Osaka City University

Division name

Nursing

Zip code


Address

, 1-5-17 Asahi Abeno, Osaka 545-0051, Japan

TEL

06-6645-3511

Email

uta.sakura.pinkuiro@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name UTAKO NISHIHARA

Organization

Graduate School of Nursing Osaka City University

Division name

Nursing

Zip code


Address

1-5-17 Asahi Abeno, Osaka 545-0051, Japan

TEL

06-6645-3511

Homepage URL


Email

uta.sakura.oinkuiro@gmail.com


Sponsor or person

Institute

Graduate School of Nursing Osaka City University

Institute

Department

Personal name



Funding Source

Organization

no founding

Organization

Division

Category of Funding Organization

Other

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

2016 Year 04 Month 01 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

2013 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 20 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

2016 Year 03 Month 22 Day

Last modified on

2016 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024860


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name