Evaluation of the effect of Mouthwash Containing aqueous Extract of saffron on Gingival Indices of Patients With Generalized moderate to severe periodontitis
Clinical evaluation of the effect of mouthwash containing aqueous extract of saffron on gum index (PD, MGI, BI) in moderate to severe periodontitis patients
Design
Clinical trials with control group, with parallel groups, double-blind, randomized using random statistical data table, the sample size is 40 people in two groups of 20
Settings and conduct
From patients with moderate to generalized periodontitis referring to Shahid Sadoughi Dental School in Yazd, 40 patients are selected according to the inclusion and exclusion criteria.Patients are randomly divided into 2 groups of 20.The control group used chlorhexidine mouthwash and the intervention group using a mouthwash containing aqueous extract of saffron. A double-blind study (patient and researcher).
Participants/Inclusion and exclusion criteria
Entry condition: Patients with moderate to severe chronic periodontitis in more than 30% of the areas, the age group is over 35 years old with no systemic diseases and less than 65 years of age, patients with more than 16 natural teeth, patients with chronic periodontitis with loss of adhesion of more than 3 mm
Non-arrival condition: Poor oral hygiene by patients
Intervention groups
Intervention group: patients with mouthwash aqueous extract of saffron
Control group: Patients with chlorhexidine mouthwash
Main outcome variables
Periodontal Pocket Depth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190402043155N1
Registration date:2019-06-03, 1398/03/13
Registration timing:retrospective
Last update:2019-06-03, 1398/03/13
Update count:0
Registration date
2019-06-03, 1398/03/13
Registrant information
Name
Vahid Herandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3625 5881
Email address
herandi.vahid@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2019-03-16, 1397/12/25
Trial completion date
2019-04-21, 1398/02/01
Scientific title
Evaluation of the effect of Mouthwash Containing aqueous Extract of saffron on Gingival Indices of Patients With Generalized moderate to severe periodontitis
Public title
Evaluation of the effect of Mouthwash Containing aqueous Extract of saffron on Gingival Indices of Patients With Generalized moderate to severe periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with moderate to severe chronic periodontitis in more than 30% of the areas
Individuals over 35 years of age without systemic diseases and under 65 years of age due to the avoidance of age-related effects on periodontal disease
Patients with more than 16 natural teeth
Patients with chronic periodontitis with loss of adhesion of more than 3 mm and evidence of radio-graphic bone resorption
Exclusion criteria:
Poor oral hygiene by patients
Age
From 35 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Use the random number table provided by the statistical software
Blinding (investigator's opinion)
Double blinded
Blinding description
Two types of mouthwashes in dark bottles (anti-light glass covers) are packaged and divided into two groups A and B by the pharmacist, which patients and dentist therapists do not know about the nature of mouthwashes until the end of the data collection.After analyzing data, the type of mouthwash is announced by the pharmacist.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
IR.SSU.REC.1397.169
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic pericoronitis
Primary outcomes
1
Description
Pocket Probing Depth
Timepoint
The beginning of the study (before the start of the intervention) and 4 weeks after starting the mouthwash
Method of measurement
Periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients treated with mouthwash containing aqueous extract of saffron
Category
Treatment - Drugs
2
Description
Control group: Patients treated with chlorhexidine mouthwash
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Faculty of Dentistry
Full name of responsible person
Vahid Herandi
Street address
Imam Reza Blvd
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Fax
+98 35 3625 0344
Email
pajoheshdentyazd@gmail.com
Web page address
http://ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaii
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9138
Email
mmirzaei@ssu.ac.ir
Web page address
https://ethic@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Vahid Herandi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Imam Reza Blvd
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Email
Herandi.vahid@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Vahid Herandi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Imam Reza Blvd
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 356255881
Email
Herandi.vahid@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Vahid Herandi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
Imam Reza Blvd
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 356255881
Email
Herandi.vahid@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available