After approval of input and output criteria, Patients were selected in 2 groups: 33 Patients had gotten diabetes 2 and Chronic periodontists. This study had been on Split mouth method. All patient were belonged to both groups (Control Group and Test Group).
For control Group SRP lonely and for test group both SRP and Chlorhexidine gel were Injected. In this study, whole the mouth were made SRP by Ultrasonic equipment. Then the test area were washed by cold saline. 10 Minutes waiting were considered to make homeostasis completed.
Chlorhexidine gel were injected to the deepest area of package by special needle injector (Round Bottom), and then a periodontal pack were placed in the area by no pressure.
Health educations like how to toothbrush were thought to patient in case patient was not allowed to use mouthwash or any other mouth washing products.
After one week patient was visited for removal of the periodontal pack. The following sessions were held after 3 and 6 months.
Any Sub-gingival instrumentation were done in the area, following meetings were held just to register clinical parameters and Metabolic control plaques of the patient.
HbA1c and FBS tests were asked for all patients and all of them were referred to a specific laboratory. All clinical parameters were reviewed in the beginning and then in next 3 and 6 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411023690N5
Registration date:2015-07-17, 1394/04/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-17, 1394/04/26
Registrant information
Name
Masoomeh Faramarzie
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1385 4863
Email address
faramarzim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Goverment
Expected recruitment start date
2014-12-09, 1393/09/18
Expected recruitment end date
2014-12-11, 1393/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical and metabolic changes after subgingival insertion of xanthan-based chlorhexidin gel in type 2 diabetic patients with chronic periodontitis.
Public title
Effect of Chlorhexidine gel in diabetic and gum disease patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of type 2 diabetes ; HbA1c ≥ 6.0% ; Clinical Diagnosis of moderate generalized chronic periodontists defined by loss of clinical attachment more than 3mm and bone loss more than 30% ; Presence of more than 10 teeth per dental arch, excluding third molars ; No previous periodontal treatment taken ; signing informed consent, and commitment to post treatment follow-up visits ; no modification in medication for two months, before or during the study
exclusion criteria: Presence of systemic disease that could influence the course of periodontal disease ; Intake of anti-inflammatory antibiotics for four weeks before the study ; current smokers or ex-smokers of <5 years ; Pregnancy or intention to be pregnant during the six months of study ; Intake of periodontal treatment in 3 months ago ;
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Not 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
Ethics Committee Of Tabriz Medical University
Street address
Street camping , Tabriz University of Medical Scienses , Tabriz University of Medical Sciences , Ethics Committee Of Tabriz Medical University
City
Tabriz
Postal code
5166614713
Approval date
2014-12-08, 1393/09/17
Ethics committee reference number
93137
Health conditions studied
1
Description of health condition studied
chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic pericoronitis Periodontitis: NOS complex simplex
Primary outcomes
1
Description
HbA1c
Timepoint
Before the experiment, three months after the intervention, six months after the intervention
Method of measurement
Examination
Secondary outcomes
1
Description
Fast Blood Sugur (FBS)
Timepoint
Befoer the experiment (Baseline) , 3 months after the intervention, 6 month after the intervention
Method of measurement
Examination
2
Description
Clinical attachment level (CAL)
Timepoint
Befoer the experiment (Baseline) , 3 months after the intervention, 6 month after the intervention
Method of measurement
with periodontal prob from CEJ to pocket depth
3
Description
Probing depth (PD)
Timepoint
Befoer the experiment (Baseline) , 3 months after the intervention, 6 month after the intervention
Method of measurement
with periodontal prob
4
Description
plaque Index
Timepoint
Befoer the experiment (Baseline) , 3 months after the intervention, 6 month after the intervention
Method of measurement
Disclosing tablets
5
Description
Bleeding Index (BI)
Timepoint
Befoer the experiment (Baseline) , 3 months after the intervention, 6 month after the intervention
Method of measurement
observe
Intervention groups
1
Description
chart completion, scaling and brushing by handheld devices, ultrasonic and Rabrkp and paste pumice in treatment during, injected the chlorhexidin within gingiva
Category
Treatment - Drugs
2
Description
chart completion, scaling and brushing by handheld devices, ultrasonic and Rabrkp and paste pumice
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gum disease and tooth Research Center, School of Dentistry, Tabriz
Full name of responsible person
Dr Masoumeh Faramarzi
Street address
University Circle - University Avenue - Tabriz University of Medical Sciences - Faculty of Dentisty,Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences, School of Dentistry, Tabriz,
Full name of responsible person
Dr Reza Pour Abbas
Street address
University Circle, University Avenue, Tabriz University of Medical Sciences, School of Dentistry, Tabriz
City
Tabriz
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 of Tabriz University of Medical Sciences, School of Dentistry, Tabriz,
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
Gum disease and tooth Research Center, School of Dentistry, Tabriz
Full name of responsible person
Dr Masoumeh Faramarzi
Position
Associate Professor of Periodontics / teacher of university
Other areas of specialty/work
Street address
University Circle, University Avenue, Tabriz University of Medical Sciences, School of Dentistry, Tabriz
City
Tabriz
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
Email
faramarzim@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gum disease and tooth Research Center, School of Dentistry, Tabriz
Full name of responsible person
Dr Masoumeh Faramarzi
Position
Associate Professor of Periodontics
Other areas of specialty/work
Street address
University Circle, University Avenue, Tabriz University of Medical Sciences, School of Dentistry, Tabriz
City
Tabriz
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
faramarzim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gum disease and tooth Research Center, School of Dentistry, Tabriz
Full name of responsible person
Sahand Ghani Tab
Position
Student Dental
Other areas of specialty/work
Street address
University Circle, University Avenue, Tabriz University of Medical Sciences, School of Dentistry, Tabriz
City
Tabriz
Postal code
Phone
00
Fax
Email
Sahandghanitab@yahoo.com ; Ojasahand67@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)