Protocol summary

Study aim
Effect of non-surgical periodontal therapy on HbA1c level in patients with chronic periodontitis
Design
In this research, 40 non-diabetic eligible patients referring to Gorgan Dental School were divided in two groups of case (patients with chronic periodontists) and control (patients with healthy periodontium). Sampling was done without randomization and research was performed as before and after study.
Settings and conduct
Basic periodontal examinations were done and 2 ml blood were taken from patients to examine HbA1c level. Tooth scaling was performed for intervention group and after 3 months HbA1c levels were reexamined.
Participants/Inclusion and exclusion criteria
Age between 20 and 65; general health; pocket depth at least 5 mm and attachment loss more than 3 mm in 5 teeth or more in intervention group and healthy periodontium in control group; presence of 10 natural teeth at least and fasting blood sugar less than 110 mg/dl
Intervention groups
HbA1c levels were examined in both groups. Scaling and root planning was done for the group with periodontists. No intervention was done for the control group. After 3 months, HbA1c levels of all participants were reexamined.
Main outcome variables
Probing pocket depth; Clinical attachment loss; HbA1c

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171215037877N1
Registration date: 2018-02-08, 1396/11/19
Registration timing: registered_while_recruiting

Last update: 2018-02-08, 1396/11/19
Update count: 0
Registration date
2018-02-08, 1396/11/19
Registrant information
Name
Farshad Arjmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3255 3324
Email address
arjmand.dds@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-10, 1396/10/20
Expected recruitment end date
2018-02-09, 1396/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of HbA1c levels in subjects with chronic periodontitis and periodontally healthy controls referring to Gorgan dental school before and after non-surgical periodontal therapy
Public title
Effect of tooth scaling on preventing Diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Participants must be generally healthy. Participants must have at least 5mm probing pocket depth or more than 3mm attachment loss in five or more teeth in the case group. Participants in control group must have healthy periodontium. Participants must have 10 natural teeth at least. Participant's fasting blood sugar must be below 110 mg/dl.
Exclusion criteria:
Patients with history of Diabetes Mellitus or any other systemic diseases affecting periodontium. Patients who have used antibiotics more than 14 days in the past 3 months. Patients who have received periodontal treatment in the past 6 months. Patients with hemolytic anemia or recent significant blood loss. Pregnancy and lactation Smokers and alcoholics.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
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 Golestan University of Medical Sciences
Street address
Falsafi complex, first of Shashtkola road
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2017-12-12, 1396/09/21
Ethics committee reference number
IR.GOUMS.REC.1396.218

Health conditions studied

1

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

Primary outcomes

1

Description
HbA1c level
Timepoint
3 months
Method of measurement
Blood sampling

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: teeth scaling and root planning
Category
Treatment - Other

2

Description
Control group: without additional work
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental School
Full name of responsible person
Farshad Arjmand
Street address
Opposite of Edalat 97, Naharkhoran Blvd
City
Gorgan
Province
Golestan
Postal code
4916953358
Phone
+98 17 3255 3324
Email
DRC.goums@gmail.com
Web page address
http://goums.ac.ir/index.php?slc_lang=fa&sid=59

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Jamileh Ramezani
Street address
Opposite of Edalat 97, Naharkhoran Blvd
City
Gorgan
Province
Golestan
Postal code
4916953358
Phone
+98 17 3255 3324
Email
Drc.goums@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Farshad Arjmand
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental College, Naharkhoran Blvd, Gorgan
City
Gorgan
Province
Golestan
Postal code
4917853338
Phone
+98 17 3255 3324
Fax
Email
master.angels93@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Farshad Arjmand
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental College, Naharkhoran Blvd, Gorgan
City
Gorgan
Province
Golestan
Postal code
4917853338
Phone
+98 17 3255 3324
Fax
Email
master.angels93@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Farshad Arjmand
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental College, Naharkhoran Blvd, Gorgan
City
Gorgan
Province
Golestan
Postal code
4917853338
Phone
+98 17 3255 3324
Fax
Email
master.angels93@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Participant's periodontal and blood examinations will be shared.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
All people
Under which criteria data/document could be used
The main researcher will review requests. All criteria will be explained in email.
From where data/document is obtainable
Data could be obtained from Dental School of Golestan University of Medical Sciences, located in Gorgan, Naharkhoran Blvd. Phone number : 0098 17 3255 3324. Request should be posed by email first. Email address : arjmand.dds@goums.ac.ir
What processes are involved for a request to access data/document
After requesting by email and explanation of criteria, data would be sent in 10 days.
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