Objectives: Effects of periodontal treatment in improvement of glycemic status of diabetic patients has been proven, so present study is designed to evaluate effect of mechanical and chemical periodontal treatment on glycemic status of diabetic patients. Design: Interventional randomized clinical trial. Setting and conduct: 30 diabetic patient which have inclusion criteria are selected and randomly divided to 15 patients in case group and 15 patients in control group. Case group receive conventional periodontal therapy and antibiotic therapy and control group receive only conventional periodontal therapy Participants including major eligibility criteria: 30 diabetic patient with chronic periodontitis with minimum 3 area in gingival sulcus with gingival probing depth more than 4 millimeter and less than 7 millimeter, selected. Systemic antibiotic user in 3 months before study, periodontal treatment user in 6 months before study, smokers, patients with acute medical problems, patients with less than 8 teeth in mouth, pregnant and nursing women exclude the study. Intervention: Case group receive conventional mechanical periodontal treatment include scaling and root planning with local application of 5% tetracycline gel (in periodontal treatment session gel is applied after scaling and root planning with syringe and remained in area with periodontal pack for 10 days) and oral hygiene education and control group receive conventional mechanical periodontal treatment with oral hygiene education. Main outcome measures (variables): Hematologic variables such as HbA1c and lipid profile are measured in the beginning of study and 3 months later and hematologic variables compare in two time of study and two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013092614774N1
Registration date:2014-02-06, 1392/11/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-06, 1392/11/17
Registrant information
Name
Yasin Asadi
Name of organization / entity
Shahid Sadoughi University of Medical Sceince
Country
Iran (Islamic Republic of)
Phone
+98 35 1828 0454
Email address
y.asadi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research of Yazd Shahid Sadoughi Dental School
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of local application of tetracycline gel with SRP on HbA1c & lipid profile in type2 diabetic patients
Public title
Effects of SRP on blood glucose level reduction in diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Diabetic patients with moderate to good blood glucose control؛ patients with chronic periodontitis with minimum 3 area in gingival sulcus with periodontal probe depth more than 4mm and less than7 mm
Exclusion criteria: Antimicrobial and antibiotic user in last 3 months؛ recipients periodontal treatment in last 6 months؛ smokers؛ patients with less than 8 teeth؛ pregnant and nursing women؛ acute medical complications
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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
Ethic Commmittee of Shahid Sadoughi University of Medical Science
Street address
Shahid Sadoughi Univercity of Medical Science, Bahoonar square, Yazd
City
Yazd
Postal code
Approval date
2013-07-13, 1392/04/22
Ethics committee reference number
71427
Health conditions studied
1
Description of health condition studied
Chronic Periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic Periodontitis
2
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes Mellitus
Primary outcomes
1
Description
HbA1c
Timepoint
At the beginning of the study & 3 months later
Method of measurement
A percent in patient`s hemmatology test
2
Description
Lipid profile
Timepoint
At the beginning of the study & 3 months later
Method of measurement
miligeram per deciliter in patient`s hemmatology test
Secondary outcomes
1
Description
Periodontal pocket depth
Timepoint
At the beginning of the study and 3 months later
Method of measurement
Millimeter and with using periodontal prob
2
Description
Plaque Index
Timepoint
At the beginning of the study and 3 months later
Method of measurement
A percent obtaine by placing colored surfaces of the teeth in O'Leary plaque index formula
3
Description
Gingival Index
Timepoint
At the beginning of the study and 3 months later
Method of measurement
A number between 1-4 according to gingival inflammation. it is completely observational
Intervention groups
1
Description
Control group: Scaling and rootplannig with ultrasonic scaler, Polishing with polish paste with low polish effect, patient education in beginning the study
Category
Treatment - Other
2
Description
Intervention group: Scaling and rootplanning with ultrasonic scaler, Polishing with polish paste with low polish effect, Patient education and after scaling and root planning, Local application of tetracycline hydrochloride 5% gel in gingival sulcus and application of periodontal pack on the tetracycline gel for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Reserch Center
Full name of responsible person
Dr Mohammad Afkhami
Street address
Diabetes Reserch Center, Jomhori-E-Eslami boulevard, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Fatemeh Ezzoddini- vice chancellor for reasearch
Street address
Bahonar square، Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Sadoughi Univercity of Medical Science
Full name of responsible person
Yasin Asadi
Position
Postgraduate student of periodontics
Other areas of specialty/work
Street address
Baran1 residential assembled, Safaeeye, Yazd
City
Yazd
Postal code
Phone
+98 35 1828 0454
Fax
Email
y.asadi@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sceince
Full name of responsible person
Yasin Asadi
Position
Postgraduate student of periodontology
Other areas of specialty/work
Street address
Baran1 residental assembled, Saffaeiye, Yazd
City
Yazd
Postal code
Phone
+98 35 1828 0454
Fax
Email
y.asadi@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science
Full name of responsible person
Yasin Asadi
Position
Postgraduate student of periodontology
Other areas of specialty/work
Street address
Baran1 residental assembled, Saffaeiye, Yazd
City
Yazd
Postal code
Phone
+98 35 1828 0454
Fax
Email
y.asadi@ssu.ac.ir yasin_asadi63@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)