Evaluation of the effect of ginger mouthwash on plaque index and gingival index
Design
A randomized double_- blind parallel group with control group clinical trial on 50 participants . Balance block randomization technique was used.
Settings and conduct
All people are given a type of signal brand fluoride toothpaste, a type of toothbrush and mouthwash of the respective group in a dark plastic by someone other than the examiner so that people are not aware of the difference between mouthwashes. People are taught to brush twice a day with a modified bass method for 3 minutes, twice a day to use mouthwash for one minute for two weeks. They are asked to refrain from using other oral hygiene aids during these two weeks. Once at the beginning of the work, once on the 7th day of the intervention and once on the 14th day, the study is evaluated and recorded. These evaluations are performed in the Periodontology Department of Qazvin Dental School.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: 18- to 45-year-olds who have at least 20 healthy teeth and, in terms of periodontal status, do not have periodontal disease and do not have a salcus deeper than 3 mm at any point.
Criteria for non-inclusion in the study include: Systemic diseases affecting oral health such as diabetes, hypertension, thyroid disease, patients with a history of oral and gingival surgery, pregnant and lactating women, taking anticholinergic and antihypertensive and anti-hypertensive drugs. Depression, a history of radiotherapy and the use of intraoral devices such as orthodontic plates.
Intervention groups
Group A : Zingiber mouthwash
Group B : Chlorhexidin mouthwash
Main outcome variables
Plaque Index / Gingival Index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220621055244N1
Registration date:2022-07-04, 1401/04/13
Registration timing:prospective
Last update:2022-07-04, 1401/04/13
Update count:0
Registration date
2022-07-04, 1401/04/13
Registrant information
Name
Shabnam Haftani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7734 8984
Email address
shabnam.haftani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-08-05, 1401/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of ginger mouthwash on plaque index and gingival index : A randomized double_- blind clinical trial
Public title
Evaluation of the effect of ginger mouthwash on plaque index and gingival index
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Students of Qazvin University of Medical Sciences in the age range of 18-45 years
Having 20 teeth at least
Having no periodontal diseases
Not having pocket depth more than 3 mm
Exclusion criteria:
Having systemic diseases affecting oral health such as diabetes , hypertension, thyroid diseases
Having the history of periodontal or oral surgeries
Pregnant or milch womens
Taking anticholinergic, antihypertensions, antidepressant drugs and history of radiotherapy
Using intraoral devices such as orthodontics appliences
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The 50 participants of the study are divided into two groups A and B using random allocation software using random block method. The size of each block is 5 and the total number of blocks is 10.Balanced random allocation method for participants in a randomized clinical trial study is used to evaluate the effect of two mouthwashes of ginger and chlorhexidine on PI and GI in 2 weeks.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants do not know about the difference between mouthwashes. Researcher and the examiner do not know that each person belongs to which group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commite of Qazvin University of Medical Sciences
Street address
Deputy o Research and Technology , The first sub , Mavedat Alley , Shahid Beheshti Boulvard
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2022-07-22, 1401/04/31
Ethics committee reference number
IR.QUMS.REC.1401.078
Health conditions studied
1
Description of health condition studied
Plaque Index / Gingival Index
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plaque Index and Gingival Index
Timepoint
Once at the beginning of the work, once on the 7th intervention day and once on the 14th intervention day
Method of measurement
The plaque index is identified at each stage using a fuchsin tablet that is chewed in the mouth for 1 minutes. This index is measured in accordance with the Quigley-Hein Turesky modification index. In this way, the buccal and lingual (palatal) surfaces of all teeth are first obtained according to the following numbers and their average is considered as the index of each tooth. By summing the indices of all teeth and dividing them by the number of teeth, the plaque index in the patient is calculated. Based on the number of license plates, one of the following six points is considered for each level:Score zero: the surface is without plates. Score 1: Plaque should be scattered in the cervical part of the tooth. Score 1: The plaque should be in the form of a thin continuous line with a maximum thickness of 1 mm in the cervical tooth. Score 1: Plaque more than 2 mm thick but less than one third of the tooth crown is covered. Score 1: The plaque is more than one third thick but less than two thirds of the tooth crown. Score 2: Plaque covers two-thirds or more of the tooth crown.The gingival index is recorded by the examiner by observing the appearance of the gingiva and also by using the Williams probe. The loe & silness method is used to examine the gingival index (Gingival index GI). The gingiva of each tooth are divided into 4 parts: mesiobuccal papilla, distobuccal papilla, midbuccal gingival margin and midlingual gingival margin and then evaluated and based on the results obtained, they are given one of the following four points:Score 0: If the gingiva have a normal appearance and are free of inflammation and bleeding. Score 1: low inflammation, slight discoloration, low edema, no bleeding during probing. Probing. Score 3: Severe inflammation, marked redness, edema and hypertrophy, ulcers and spontaneous bleeding. To achieve the GI of each tooth, the average GI of all surfaces of that tooth is considered, and to achieve the total oral GI, the average GI of all the examined teeth is considered.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use ginger mouthwash twice a day for one minute for two weeks. Vi one Ginger mouthwash contains deionized water, ginger extract, glycerin, polyethylene glycol 40, xylitol, potassium sorbate, ploxamer 407, citric acid, menthol, sodium saccharin
Category
Prevention
2
Description
Control group: Use Chlorhexidine mouthwash twice a day for one minute for two weeks. Chlorhexidine mouthwash 0.2% vi One contains deionized water, sorbitol, glycerin, polyethylene glycol, xylitol, polysorbate 20, ploxamer 407, citric acid, menthol, chlorhexidine digluconate 0.2%, essential oil
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences
Full name of responsible person
Shabnam Haftani
Street address
Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3415759811
Phone
+98 28 3334 4631
Fax
+98 28 3335 5162
Email
internationalaffairs@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Mehdi Mirhashemi
Street address
Deputy of Research and Technology , First Sub, Mavedat Alley,Shahid Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3336 8124
Fax
+98 28 3335 0056
Email
researdhdpt@qums.ac.ir
Web page address
http://vcr.qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Shabnam Haftani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No198, Qasaban Alley, Shahed Square
City
Tehran
Province
Tehran
Postal code
1656667161
Phone
+98 21 7734 8984
Email
shabnam.haftani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Shabnam Haftani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No198, Qasaban Alley, Shahed Square
City
Tehran
Province
Tehran
Postal code
1656667161
Phone
+98 21 7734 8984
Email
shabnam.haftani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Shabnam Haftani
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No198, Qasaban Alley, Shahed Square
City
Tehran
Province
Tehran
Postal code
1656667161
Phone
+98 21 7734 8984
Email
shabnam.haftani@gmail.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