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The development of comprehensive health promotion model for adult diabetes mellitus patients using non-surgical periodontal treatment program

Status Approved

First Submitted Date

2019/07/04
Registered Date

2019/07/16
Last Updated Date

2019/07/11

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0004146
Unique Protocol ID	860-20130039
Public/Brief Title	The development of comprehensive health promotion model for adult diabetes mellitus patients using non-surgical periodontal treatment program
Scientific Title	The development of comprehensive health promotion model for adult diabetes mellitus patients using non-surgical periodontal treatment program
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	S-D20130016
Approval Date	2013-05-30
Institutional Review Board Name	Seoul National University, School of Dentistry, Medical research ethics committee
Institutional Review Board Address	101, Daehak-ro, Jongno-gu, Seoul
Institutional Review Board Telephone	02-740-8702
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	BoHyoung Jin
Title	Prof.
Telephone	+82-2-740-8782
Affiliation	Seoul National University Dental Hospital
Address	101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	JaeYoung Lee
Title	Mr.
Telephone	+82-2-740-8782
Affiliation	Seoul National University
Address	101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea
Contact Person for Updating Information
Name	JaeYoung Lee
Title	Mr.
Telephone	+82-2-740-8782
Affiliation	Seoul National University
Address	101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2013-06-03 Actual
Target Number of Participant	75
Primary Completion Date	2014-05-30 , Actual
Study Completion Date	2014-05-30 , Actual
Name of Study	Seoul National University
Recruitment Status	Completed
Date of First Enrollment	2013-06-03 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Korea Health Promotion Institute
Organization Type	Others
Project ID	13-15

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Seoul National University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	After changing and applying non-surgical methods of periodontal treatment, we will evaluate changes in oral health, improvement in glycemic control ability, changes in the body's inflammatory index. We tried to show optimal non-surgical periodontal treatment method for diabetic patients

Study Summary Information

Lay Summary

After changing and applying non-surgical methods of periodontal treatment, we will evaluate changes in oral health, improvement in glycemic control ability, changes in the body&#39;s inflammatory index. We tried to show optimal non-surgical periodontal treatment method for diabetic patients

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator, Outcome Accessor
Allocation	RCT
Intervention Type	/Procedure/Surgery
Intervention Description	Types of non surgical periodontal treatment
Number of Arms	3
Arm 1	Arm Label Scaling and root planning group
	Target Number of Participant 25
	Arm Type Experimental
	Arm Description Non-surgical periodontal treatment will be performed on randomly assigned subjects, oral examination will be conducted a total of 3 times(1, 9, 12 weeks). Supragingival calculus removal (at 1 week) and subgingival calculus removal (at 3 weeks) will be performed
Arm 2	Arm Label Professional maintenance care group
	Target Number of Participant 25
	Arm Type Experimental
	Arm Description Non-surgical periodontal treatment will be performed on randomly assigned subjects, oral examination will be conducted a total of 3 times(1, 9, 12 weeks). Supragingival calculus removal (at 2 week) and subgingival calculus removal (at 3 weeks) will be performed From 1 week to 5 weeks, participants were taken additionally expert tooth brushing (Watanabe method) for removal dental plaque.
Arm 3	Arm Label Controlgroup
	Target Number of Participant 25
	Arm Type No intervention
	Arm Description Patients who are randomly assigned to control group and performed a total of three oral examinations for the study (1, 9, 12 weeks).

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (E00-E90)Endocrine, nutritional and metabolic diseases (E14.9)Unspecified diabetes mellitus, without complications diabetes mellitus with periodontitis
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description 1. Pocket depth ≧ 4mm 2. Non-smoker 3. 2 or more sites with attachment loss 4. No change in courses of treatment ※Oral anti-diabetic drug 3 months before and during the study
Exclusion Criteria	1. ≦20 teeth 2. Systemic disease (ex. SLE, HIV, AIDS etc.) 3. No periodontal treatment received 3 months before the study 4. Chronic liver disease including Hepatitis 5. BMI (Body Mass Index) ≧ 40 6. Pregnant 7. Current abuse of alcohol or drugs 8. HbA1C<6.5%
Healthy Volunteers

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Glycated hemoglobin, HbA1c
Timepoint	1week, 12weeks
Secondary Outcome(s) 1
Outcome	Serum Endotoxin (Limulus Amebocyte Lysate)
Timepoint	1week, 12weeks
Secondary Outcome(s) 2
Outcome	Serum Interlukin 1-beta
Timepoint	1week, 12weeks
Secondary Outcome(s) 3
Outcome	Pocket depth
Timepoint	1week, 12weeks
Secondary Outcome(s) 4
Outcome	Bleeding on probing
Timepoint	1week, 12weeks
Secondary Outcome(s) 5
Outcome	Calculus index
Timepoint	1week, 12weeks
Secondary Outcome(s) 6
Outcome	Health related quality of life (Short-Form-36 Health Survey;SF-36)
Timepoint	1week, 12weeks

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	Yes Published Results Upload
Final Enrollment Number	75
Number of Publication	1
Publications 1	YoonYoung Choi, JaeYoung Lee, Heeyoung Lee, BoHyoung Jin. Assessment of the quality of life and oral health status in diabetic patients. Journal of Korean Academy of Oral Health. Non SCI. 2015-09-01 , VOL : 39 page : 207 ~ 213 https://doi.org/10.11149/jkaoh.2015.39.3.207
Results Upload	결과보고서 +진보형_서울대학교6.pdf
Date of Posting Results	2019/07/16
Protocol URL or File Upload	결과보고서 +진보형_서울대학교7.pdf
Brief Summary	- In SRP, PMC group, there was decreation of pocket depth, Bleeding on probing rate, calculus index - In SRP group, there was decreation of HbA1c - In PMC group, there was decreation of HbA1c, Endotoxin - In the SRP group, physical functioning and the mental health score increased

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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