![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000021564 |
Receipt No. | 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 |
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 |
|
Condition | |||||
Condition | type 2 diabetes | ||||
Classification by specialty |
|
||||
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 | ||||||
uta.sakura.pinkuiro@gmail.com |
Public contact | |||||||
Name of contact person |
|
||||||
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 | |||||||
uta.sakura.oinkuiro@gmail.com |
Sponsor | |
Institute | Graduate School of Nursing Osaka City University |
Institute | |
Department |
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 | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.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 |