To evaluate effect of Iranian Traditional mouth rinse on controlling diabetic gingivitis and comparing it with Chlorhexidine among patients of Motahhari Clinic of shiraz in 2014.
This is a triple blinded randomized clinical trial by which we want to evaluate the effect of an Iranian Traditional mouth rinse on treatment of diabetic gingivitis and compare it with chlorhexidine (2%).
Among diabetic patients who refer to Motahhari clinic of Shiraz University of Medical Sciences 80 volunteers who have gingivitis and aged between 20 to 65 years old and fulfill other including criteria, are selected and randomly distributed into intervention or control groups. Then all the patients are under gone a training panel about mouth hygiene and receive a pack of a toothbrush, a toothpaste, a dental floss and a mouth rinse. They are asked to return after 2 weeks for the second evaluation and taking tooth bleaching. The demographic and general information of all participants are taken and the primary outputs (plaque index and bleeding on probe) are measured at the beginning, after 2 weeks and after 4 weeks. All the examinations are done by one person and as told before; patients, practitioner and statistical manager are blind about the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014071518490N1
Registration date:2014-09-16, 1393/06/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-16, 1393/06/25
Registrant information
Name
Massih Sedigh Rahimabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3825 6275
Email address
sedighrm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shiraz University of Medical Sciences
Expected recruitment start date
2014-07-21, 1393/04/30
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate effect of Iranian Traditional mouth rinse on controlling diabetic gingivitis and comparing it with Chlorhexidine among patients of Motahhari Clinic of shiraz in 2014.
Public title
To evaluate effect of Iranian Traditional mouth rinse on gingival bleeding of diabetic patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Controlled diabetes (FBS<130 or Hg A1C<7); Presence of Gingivitis; Having at least 20 teeth; Not to have any history of hypersensitivity; Age between 20 to 65; Not to smoke more than 2 cigarette per day; Not to have any systemic diseases like; liver or rheumatologic diseases; Agreement to participate in the study. Exclusion criteria: uncontrolled diabetes (FBS>130 or Hg A1C>7); Absence of Gingivitis; Having less than 20 teeth; having history of hypersensitivity; Age less than 20 or above 65; Smoke more than 2 cigarette per day; Having systemic diseases like; liver or rheumatologic diseases; Not agree to participate in the study.
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:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Clinicaltrials.gov
Secondary trial Id
NCT02227485
Registration date
2014-08-01, 1393/05/10
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chansellor for research affair of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Ave.
City
Shiraz
Postal code
Approval date
2014-07-01, 1393/04/10
Ethics committee reference number
CT93747064
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05.0, K05
ICD-10 code description
Acute and chronic gingivitis
Primary outcomes
1
Description
Plaque index
Timepoint
Every 2 weeks for one month
Method of measurement
Exam
2
Description
Bleeding Index
Timepoint
Every 2 weeks for one month
Method of measurement
exam
Secondary outcomes
1
Description
Drug side effects
Timepoint
After 2 weeks
Method of measurement
History taking and Exam
2
Description
Satisfaction of patients
Timepoint
After 2nd week
Method of measurement
By VAS
Intervention groups
1
Description
Control group: Cholorhexidine (2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks.
Category
Treatment - Drugs
2
Description
Intervention: Traditional mouth rinse, 10 ml for 2 minutes every night for 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari clinic of Shiraz University of Medical Sciences
Full name of responsible person
Massih Sedigh Rahimabadi
Street address
Motahhari clinic, Namazi sq.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellery of research and technology, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahmeddini
Street address
Vice Chancellery of research and technology, Shiraz University of Medical Sciences, Zand Ave.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery of research and technology, Shiraz 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
Faculty of Iranian Traditional Medicine
Full name of responsible person
Sedigh Rahimabadi Massih
Position
PhD Student
Other areas of specialty/work
Street address
Imam Hasan dormitory, Dejban st.
City
Shiraz
Postal code
00987112309979
Phone
+98 71 1230 9979
Fax
Email
massih21@yahoo.com; sedighrm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Medicine
Full name of responsible person
Dr. Mesbah Shams
Position
Associate professor of Endocrine and Metabolic diseases
Other areas of specialty/work
Street address
Namazi hospital, Namazi sq.
City
Shiraz
Postal code
Phone
+98 71 1647 4332
Fax
Email
shams@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iranian Traditional Medicine
Full name of responsible person
Mahsa Rostami Chijan
Position
Student
Other areas of specialty/work
Street address
Faculty of Medicine, Setad sq.
City
Shiraz
Postal code
Phone
+7 112309979
Fax
Email
mahsa_59_2007@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)