The aim of this study is comparing effects of Persica and Chlorhexidine mouthwashes on color of tooth, gingival bleeding and pain after Scaling. This study is Randomized clinical trial and double blind, controlled by placebo and phases two and three of trial. Having 2 quadrant or more with CPITN more than one and less than three is major Inclusion criteria and Having systemic conditions or diseases is major exclusion criteria.
In this clinical trial, 48 patients suffering from gingivitis, referring to department of periodontics of Yazd ِِDental School are evaluated randomly in 3 groups (16 patient in each group). Before any interventions, gingival bleeding index and color of tooth index are evaluated. Then, Normal Saline (placebo) is given to the first group, Chlorhexidine is given to the second group and Persica is given to the third group.Then, gingival bleeding Index and color of tooth index are evaluated after prescription of mouthwashes and placebo for the second time. In the next stage, After scaling, pain index is evaluated for the first time.Then, mouthwashes and placebo are prescribed for one week. Finally three indexes are evaluated after a week. Primary outcomes of this study are gingival bleeding and pain after scaling.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012816407N1
Registration date:2014-07-10, 1393/04/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-10, 1393/04/19
Registrant information
Name
Motahare Baghestani
Name of organization / entity
Dental school ,Shahid Sadoughi university of science, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 1522 4745
Email address
baghestani@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2014-04-09, 1393/01/20
Expected recruitment end date
2014-04-30, 1393/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of Chlorhexidine and Persica mouthwashes on color of tooth, gingival bleeding and pain after Scaling in patients suffering gingivitis
Public title
Effect of Persica mouthwash on the color of tooth, gingival bleeding and pain after scaling
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: Having 2 quadrant or more with CPITN more than one and less than three؛ being healthy systematically
Exclusion: Having systemic conditions or diseases; pregnancy; smoking; puberty
Age
From 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd Shahid Sadoughi University of Medical Sciences
Street address
Shahid Bahonar square, Yazd, Islamic Republic of Iran
City
Yazd
Postal code
Approval date
2013-07-13, 1392/04/22
Ethics committee reference number
17.1.71408پ
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
Gingival bleeding
Timepoint
Before intervention, after using mouthwashes, one week after using mouthwash
Method of measurement
By bleeding on probing (BOP): not bleeding number zero, bleeding less than a dot number one, bleeding more than a dot number two
2
Description
Pain
Timepoint
After scaling, one week after using mouthwashes
Method of measurement
Visual Pain Scale
Secondary outcomes
1
Description
Color of tooth
Timepoint
befor intervention, after using mouthwashes, one week after using mouthwashes
Method of measurement
Having or do not having color changing (number and percent of teeth with color changing)
Intervention groups
1
Description
Normal Saline (placebo) is given to the patients of the first group and they are requested to use it 3 times a day, each time 30 seconds for a week (each time 15 mili litre). They are requested to do not eat any things and do not wash their mouth until one hour after using it.
Category
Placebo
2
Description
Chlorhexidine is given to the patients of the second group and they are requested to use it 3 times a day, each time 30 seconds for a week(each time 15 mili litre). They are requested to do not eat any things and do not wash their mouth until one hour after using it.
Category
Prevention
3
Description
Persica is given to the patients of the third group and they are requested to use it 3 times a day, each time 30 seconds (each time, 15 drops of Persica are fallen in 2 spoons of water) for a week. They are requested to do not eat any things and do not wash their mouth until one hour after using it.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of periodontics, School of dentistry, Shahid Sadoughi Medical University,Yazd, Iran
Full name of responsible person
Dr. Ahmad Haerian (Associate professor, Department of periodontics)
Street address
Fazayesabz, Yazd, Yazd, Islamic Republic of Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Hasan Mozaffari
Street address
Shahid Bahonar square, Yazd, Islamic Republic of Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Ahmad Haerian
Position
Associate professor
Other areas of specialty/work
Street address
Dental School, Fazaye sabz, Yazd, Islamic Republic of Iran
City
Yazd
Postal code
Phone
+98 35 1620 4761
Fax
Email
dr.ahmad_haerian@ssu.ac.ir
Web page address
www.ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Islamic Republic of Iran
Full name of responsible person
Dr. Mohammad Hasan Akhavan Karbasi
Position
Assistant professor
Other areas of specialty/work
Street address
Dental School, Fazaye sabz, Yazd, Islamic Republic of Iran
City
Yazd
Postal code
Phone
+98 35 1621 2623
Fax
Email
pooriakarbassi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Motahare Baghestani
Position
Undergraduate student of Dentistry
Other areas of specialty/work
Street address
Dental Scool, Fazaye sabz, Yazd, Islamic Republic of Iran
City
Yazd
Postal code
8917774145
Phone
+98 35 1522 4745
Fax
Email
baghestani.motahare@yahoo.com
Web page address
www.ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)