Clinical evaluation of the effect of pedicough mouthwash on plaque control and gingival inflammation in patients with gingivitis and also the introduction of a herbal mouthwash to reduce gingivitis parameters and improve plaque control
Design
The study is a parallel double blind study. Randomization and assignment of patients to each of the three groups is done by the ward nurse. Three mouthwashes are offered in the same package to 45 patients .Patients, administrator and student are not aware of the type of mouthwash. Randomization will be performed by sealed computer assisted files.
The data will be analyzed by SPSS software version 17.
Settings and conduct
45 patients with generalized gingivitis, referred to the periodontology department of Shiraz University of Medical Sciences
Participants/Inclusion and exclusion criteria
This study will be performed on 45 patients with generalized gingivitis, referred to the periodontology department of Shiraz University of Medical Sciences. Examination of the clinical status and initial selection of the patients will be performed in the ward. In this study, smokers, pregnant women, patients with a history of medical problems that interfere with periodontal treatment, people who have done scaling and root planing in the past 3 months or have taken antibiotics in the past month will be excluded from the study.
Intervention groups
Individuals are randomly divided into three groups of fifteen. One group will be given chlorhexidine mouthwash, another group will receive a herbal mouthwash made from pedicough syrup, and the third group will receive a placebo mouthwash.
Main outcome variables
Gingival index (Loe and sillnes); Bleeding index (lenox); Plaque index (PI) (oleary)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211130053233N1
Registration date:2022-03-17, 1400/12/26
Registration timing:registered_while_recruiting
Last update:2022-03-17, 1400/12/26
Update count:0
Registration date
2022-03-17, 1400/12/26
Registrant information
Name
maedeh ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3823 2607
Email address
maedeh1996gh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-19, 1400/11/30
Expected recruitment end date
2022-05-19, 1401/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of herbal mouthwash (pedicough) on plaque control and gingival inflammation in gingivitis patients
Public title
Effect of Pedicough on gingival inflmmation and oral hygein
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with generalized marginal and papillary gingivitis
Exclusion criteria:
Smokers
Pregnancy
History of medical problems that interfere with periodontal treatment
People who have had SRP in the past 3 months, or who have taken antibiotics in the past month
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation in test and control groups will be randomly
assigned to each patient by computer-generated
random number table. The randomization codes will be
stored in password-protected portable computers and
enclosed in sequentially numbered, identical.
sealed envelopes. The sealed envelopes will be opened in
numerical order after scaling and root planing and before allocation of mouth washes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double blind. Randomization and assignment of patients to each of the three groups is done by the ward nurse, and the student who performs the scaling, examinations, and measurements is blind from the grouping. Also, three mouthwashes are offered to patients in three identical packages that patients, administrators and students are not aware of the type of the mouthwash.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiaz Dental School, Ghasroldasht Ghomabad Ave.
City
shiraz
Province
Fars
Postal code
719561578
Approval date
2022-02-18, 1400/11/29
Ethics committee reference number
IR.SUMS.DENTAL.REC.1400.079
Health conditions studied
1
Description of health condition studied
Gingivitis (gingival inflammation)
ICD-10 code
K05.10
ICD-10 code description
Chronic gingivitis, plaque induced
Primary outcomes
1
Description
Lenox bleeding inde : Evaluation of gingival bleeding
Timepoint
Before and after intervention
Method of measurement
williams probe
2
Description
Oleary plaque inex:evaluation of tooth surface plaque
Timepoint
Before and after intervention
Method of measurement
By disclosing tablets
3
Description
Gingival index : Loe and Sillness
Timepoint
Before and after intervention
Method of measurement
Evaluation of gingival inflammation signs and bleeding
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving test mouth wash pedicough(by Dine factory).15 ml each time and twice a day for 2 minutes each time for 2 weeks, use this mouthwash (in the form of rotation in the mouth).
Category
Treatment - Drugs
2
Description
Intervention group: receiving chlorhexidine mouth wash(2% of Darobox Pharmaceutical Company).15 ml each time and twice a day for 2 minutes each time for 2 weeks, use this mouthwash (in the form of rotation in the mouth).
Category
Treatment - Drugs
3
Description
Control group: receiving plasibo .Taken from the pedicough syrup (base prepared in Shiraz School of Pharmacy).15 ml each time and twice a day for 2 minutes each time for 2 weeks, use this mouthwash (in the form of rotation in the mouth).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Dental School
Full name of responsible person
Dr Farein Kiani Yazdi
Street address
Shiraz Dental School, Ghasrodasht ave.
City
Shiraz
Province
Fars
Postal code
719561578
Phone
+98 917 315 2796
Email
farinkiani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mahtab Memarpoor
Street address
ghasrodasht ave shiraz dental school
City
shiraz
Province
Fars
Postal code
719561578
Phone
+98 71 3626 3194
Email
memarpour@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr Farin Kiani Yazdi
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz Dental School, Ghasrodasht ave.
City
Shiraz
Province
Fars
Postal code
719561578
Phone
+98 917 315 2796
Email
farinkiani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Farin Kiani Yazdi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz Dental School, Ghasrodasht ave.
City
Shiraz
Province
Fars
Postal code
719561578
Phone
+98 917 315 2796
Email
farinkiani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Farin Kiani Yazdi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz Dental School, Ghasrodasht ave.
City
Shiraz
Province
Fars
Postal code
719561578
Phone
+98 917 315 2796
Email
farinkiani@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