Unique ID issued by UMIN | UMIN000021564 |
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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 |
Implementation and evaluation of a periodontal disease care program for patients with type 2 diabetes
a randomized controlled trial
Implementation and evaluation of a periodontal disease care program for patients with type 2 diabetes
a randomized controlled trial
Japan |
type 2 diabetes
Endocrinology and Metabolism | Dental medicine | Nursing |
Adult |
Others
NO
This study aimed to administer a periodontal disease care program to patients with type 2 diabetes and to evaluate its effectiveness.
Efficacy
bleeding on probing (BOP)
tests at baseline and at 6 months
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Numbered container method
2
Educational,Counseling,Training
Behavior,custom |
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.
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.
20 | years-old | <= |
100 | years-old | >= |
Male and Female
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.
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.
66
1st name | |
Middle name | |
Last name | UTAKO NISHIHARA |
Graduate School of Nursing Osaka City University
Nursing
, 1-5-17 Asahi Abeno, Osaka 545-0051, Japan
06-6645-3511
uta.sakura.pinkuiro@gmail.com
1st name | |
Middle name | |
Last name | UTAKO NISHIHARA |
Graduate School of Nursing Osaka City University
Nursing
1-5-17 Asahi Abeno, Osaka 545-0051, Japan
06-6645-3511
uta.sakura.oinkuiro@gmail.com
Graduate School of Nursing Osaka City University
no founding
Other
NO
2016 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2013 | Year | 05 | Month | 01 | Day |
2013 | Year | 05 | Month | 20 | Day |
2016 | Year | 03 | Month | 22 | Day |
2016 | Year | 03 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024860
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