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Evaluation of effect of nonsurgical periodontal therapy on hemoglobin A1c and c1 reactive protein value in type 2 diabetes mellitus pateints.

Protocol summary

Study aim
The aim of this study is to evaluate the effect of nonsurgical periodontal therapy on serum hemoglobin A1c and c1 reactive protein levels in type 2 diabetes mellitus.
Design
clinical trial with control group, with a parallel group design of 42 patients, not blinded, randomised
Settings and conduct
Diabetic patients of Razi and besat Specialty Clinics in rasht will be chosen if they satisfy inclusion criteria. At baseline of study, all patients receive HbA1C and CRP tests in the Razi laboratory, and in the first session, periodontal indicies will be measured for all patients using the Williams periodontal probe. After 3 months, all patients will be rechecked.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with chronic periodontitis who have not received any periodontal or antimicrobial treatment in the past 6 months and no change in diabetic drug regimen in the past 3 months, diabetes diagnosed by a physician for approximately 6 months. exclusion criteria: chronic pulmonary disease, malignancies, heart disease, transplanted patients, history of infection and trauma, alcoholic and smoker patients, pregnant patients, patients with severe periodontitis.
Intervention groups
Patients are divided into two groups. In intervention group scaling and root planning are performed for patients by an ultrasonic device with slim head in a one hour session . supra gingival and sub gingival calculus is removed. In control group scaling and root planing are not performed. tooth brushing with modified bass technique (twice daily), using dental floss (once a day) and chlorhexidine 0.12% twice a day are Prescribed for all patients. after the study ends, Scaling and root planing will be performed for control group.
Main outcome variables
Clinical attachment loss, plaque index, gingival index, pocket depth, gingival bleeding index, c1 reactive protein and Hba1c

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190721044287N1
Registration date: 2019-12-21, 1398/09/30
Registration timing: registered_while_recruiting

Last update: 2019-12-21, 1398/09/30
Update count: 0
Registration date
2019-12-21, 1398/09/30
Registrant information
Name
mohamad moshtaghi moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3348 6416
Email address
dr.moshtaghi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of nonsurgical periodontal therapy on hemoglobin A1c and c1 reactive protein value in type 2 diabetes mellitus pateints.
Public title
Effect of non surgical periodontal therapy in treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic periodontitis who have not received any periodontal treatment in the past 6 months Periodontal patients who have not received any antimicrobial treatment in the past 3 months Patients with at least 14 teeth in mouth and pocket depth ≥ 5 mm in at least 4 areas and clinical attachment loss ≥3 mm in at least 4 areas Diabetes diagnosed by a physician for about 6 months Patients unchanged in their diabetic drug regimen for the past 3 months
Exclusion criteria:
Patients with advanced diabetic problems (macrovascular and microvascular) Chronic pulmonary disease Kidney and liver disease Malignancies Heart disease (coronary artery disease) Transplanted patients History of infection and trauma Alcoholic and Smoker Patients Pregnant people Patients with severe periodontitis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
The research units were divided into two groups of intervention and control, using six-dimensional permutation blocks. First, possible blocks are listed (AAABBB, ABABAB, BABABA, BBABAA and ….) and each block is assigned a number. Then, using a random number table, a number is chosen. The subjects are assigned to the intervention and control groups based on the block corresponding to the chosen number. This will continue until the sample size is complete.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Dental Faculty,GUMS Complex, Fuman_Saravan Ring Road,
City
Rasht
Province
Guilan
Postal code
4188794755
Approval date
2019-09-07, 1398/06/16
Ethics committee reference number
ir.gums.rec.1398.307

Health conditions studied

1

Description of health condition studied
moderate chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis

2

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Hb A1c
Timepoint
At baseline and 3 months later.
Method of measurement
Sebia apparatus for measuring Hba1c using electrophoresis capillary kit.

2

Description
C1 Reactive Protein
Timepoint
At baseline and 3 month later
Method of measurement
Hitachi912 apparatus for measuring c1 reactive protein using bionik kit

3

Description
Clinical attachment loss index
Timepoint
At baseline and 3 months later
Method of measurement
Using William's periodontal probe

4

Description
Gingival index
Timepoint
At baseline and 3 month later
Method of measurement
Using Leo & Sillness gingival inflammation index

5

Description
Pocket depth index
Timepoint
At baseline and 3 month later
Method of measurement
Using William's periodontal probe

6

Description
Gingival bleeding index
Timepoint
At baseline and 3 month later
Method of measurement
Using William's periodontal probe

7

Description
plaque index
Timepoint
At baseline and 3 month later
Method of measurement
Using disclosing agent by O'leary Index method

Secondary outcomes

empty

Intervention groups

1

Description
In intervention group scaling and root planning are performed for patients by an ultrasonic device with slim head in a one hour session . supra gingival and sub gingival calculus is removed. presence of calculus is checked by an explorer. If needed, hand instrument is used for sites which are out of access. Patients are prescribed tooth brushing with modified bass technique (twice daily), using dental floss (once a day) and chlorhexidine 0.12% twice a day.
Category
Treatment - Devices

2

Description
In control group scaling and root planing are not performed. Patients are prescribed tooth brushing with modified bass technique (twice daily), using dental floss (once a day) and chlorhexidine 0.12% twice a day. after the study ends, Scaling and root planing will be performed for control group.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Specialty Clinic
Full name of responsible person
Dr Heydar Ali Baloo
Street address
Balal Zade Alley, Shahid Beheshti Blvd
City
Rasht
Province
Guilan
Postal code
41941-73774
Phone
+98 13 3348 6406
Fax
+98 13 3348 6423
Email
dental@gums.ac.ir
Web page address

2

Recruitment center
Name of recruitment center
Besat Specialty Clinic
Full name of responsible person
Dr Heydar Ali Baloo
Street address
Enghelab Alley, Motahari Ave.
City
Rasht
Province
Guilan
Postal code
41941-73774
Phone
+98 13 3348 6406
Fax
+98 13 3348 6423
Email
dental@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Shadman Nemati
Street address
In front of 17shahrivar Hospital, Siadati Ave., Namju Ave.
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3348 6406
Fax
+98 13 3348 6423
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Rashed Ghorbandoust
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dentistry Faculty, GUMS Complex, Fuman_saravan Ring Road
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3324 2361
Email
rashed.ghd@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Moshtaghi Moghadam
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry Faculty, GUMS Complex, Fuman-saravan Ring Road
City
Rasht
Province
Guilan
Postal code
4194173744
Phone
+98 13 3348 6406
Email
Dr.moshtaghi@gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Rashed Ghorbandoust
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dentistry Faculty, GUMS complex, Fuman-saravan Ring Road
City
Rasht
Province
Guilan
Postal code
4194173744
Phone
+98 13 3324 2361
Email
rashed.ghd@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data relative to measured index are shared after unidentifying patients.
When the data will become available and for how long
6 months or 1 year after the publication of final results
To whom data/document is available
Anyone can access the data
Under which criteria data/document could be used
In order to design and perform similar research or as a base for more development studys
From where data/document is obtainable
Rashed Ghorbandoust: rashed.ghd@gmail.com Dr Mohammad Moshtaghi moghadam: Dr.moshtaghi@gums.ac.ir
What processes are involved for a request to access data/document
After sending an email and explaining about the study, they will receive the data in a month.
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