Effect of green Kemphor mouthwash versus chlorhexidine mouthwash on the tooth staining and gingivitis in patients undergoing oral surgery or periodontal treatment: a randomized clinical trial
To assess the effect of green Kemphor mouthwash versus chlorhexidine mouthwash on the tooth staining and gingivitis in patients undergoing oral surgery or periodontal treatment
Design
This is a randomized clinical trial, phase II, in which 38 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients undergoing oral surgery or periodontal treatment and will refer to the School of Dentistry in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Patients needing chlorhexidine mouthwash after oral surgery or periodontal treatment,
Plaque index greater than or equal to 30%
Exclusion criteria:
Pregnancy,
Using cigarette of narcotic drugs,
Consuming at least three times a day tea, coffee or soda,
Use of toothpaste containing chlorhexidine or anti-plaque and bleaching agents
Intervention groups
Intervention group:
Green Kemphor mouthwash (manufacture by Kemphor Company) 15 ml twice daily for 2 weeks, and then 4-day washout period (not using mouthwash), and then chlorhexidine mouthwash (manufactured by Iran Najo Company) 15 ml twice daily for 2 weeks
Control group:
Chlorhexidine mouthwash (manufactured by Iran Najo Company) 15 ml twice daily for 2 weeks, and then 4-day washout period (not using mouthwash), and then green Kemphor mouthwash (manufacture by Kemphor Company) 15 ml twice daily for 2 weeks
Main outcome variables
Primary outcome:
Gingivitis, tooth staining
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N327
Registration date:2019-12-28, 1398/10/07
Registration timing:prospective
Last update:2019-12-28, 1398/10/07
Update count:0
Registration date
2019-12-28, 1398/10/07
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of green Kemphor mouthwash versus chlorhexidine mouthwash on the tooth staining and gingivitis in patients undergoing oral surgery or periodontal treatment: a randomized clinical trial
Public title
Effect of green Kemphor mouthwash versus chlorhexidine mouthwash on the tooth staining and gingivitis in patients undergoing oral surgery or periodontal treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Patients needing chlorhexidine mouthwash after oral surgery or periodontal treatment,
Plaque index greater than or equal to 30%
Exclusion criteria:
Pregnancy,
Using cigarette of narcotic drugs,
Consuming at least three times a day tea, coffee or soda,
Use of toothpaste containing chlorhexidine or anti-plaque and bleaching agents
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-11-23, 1398/09/02
Ethics committee reference number
IR.UMSHA.REC.1398.674
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
Gingivitis
Timepoint
Before the intervention and 2 and 4 weeks after that
Method of measurement
By physical examination
2
Description
Tooth staining
Timepoint
Before the intervention and 2 and 4 weeks after that
Method of measurement
By physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Green Kemphor mouthwash (manufacture by Kemphor Company) 15 ml twice daily for 2 weeks, and then 4-day washout period (not using mouthwash), and then chlorhexidine mouthwash (manufactured by Iran Najo Company) 15 ml twice daily for 2 weeks
Category
Treatment - Other
2
Description
Control group: Chlorhexidine mouthwash (manufactured by Iran Najo Company) 15 ml twice daily for 2 weeks, and then 4-day washout period (not using mouthwash), and then green Kemphor mouthwash (manufacture by Kemphor Company) 15 ml twice daily for 2 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry in Hamadan city
Full name of responsible person
Fetemeh Olad
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fatemeolad.1994@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fetemeh Olad
Position
Dentistry Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fatemeolad.1994@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Amir Arsalan Hooshyarfard
Position
Periodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Dr.A.Hooshyarfard@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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