Evaluation of the effect of using lemon verbena mouthwash on microbial plaque and reduce gingivitis
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients, randomized
Settings and conduct
A total of 60 patients referred to Mashhad Dental School who are diagnosed with gingivitis will be included in the study.
Blinding is done with the help of random numbers and specified code. Data analyzers and outcome assessors are blinded in this study. Patients are divided into three groups; The first group receives lemonade mouthwash, the second group receives chlorhexidine mouthwash and the third group receives placebo. All three groups use mouthwash twice a day for 10 cc each time for two weeks.
On days 0 and 15 and 30, the indices were measured and the effect of lemon mouthwash on microbial plaque and reduction of gingivitis was determined by analyzing the data.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having an average gingival index of all teeth at least 1، average plaque index of all teeth at least 1، average probing depth of all teeth maximum 3mm، without clinical attachment loss
Exclusion criteria: Pregnancy and lactation، Systemic diseases that cause generalized gingivitis، Lack of refer for follow-up، Lack of oral hygiene
Intervention groups
The first group receives lemonade mouthwash, the second group receives chlorhexidine mouthwash and the third group receives placebo. All three groups use mouthwash twice a day for 10 cc each time for two weeks.
Main outcome variables
gingival index, plaque index, bleeding index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140817018834N10
Registration date:2021-07-13, 1400/04/22
Registration timing:prospective
Last update:2021-07-13, 1400/04/22
Update count:0
Registration date
2021-07-13, 1400/04/22
Registrant information
Name
Nahid Nasrabadi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences of Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 1621 2623
Email address
nasran@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of lemon verbena mouthwash on gingivitis in comparison with chlorhexidine: A clinical study
Public title
ٍEffect of lemon verbena mouthwash on gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
average gingival index of all teeth at least 1
average plaque index of all teeth at least 1
average probing depth of all teeth maximum 3mm
without clinical attachment loss
Exclusion criteria:
Pregnancy and lactation
Systemic diseases that cause generalized gingivitis
Lack of refer for follow-up
Lack of oral hygiene
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple.
Patients will be randomly divided into three groups using a table of random numbers. A random number is assigned to each group and the intervention is determined accordingly. Each patient is given a code.
For blinding with the help of random numbers and specified code, the type of intervention is placed in the envelope. The type of intervention is the use of mouthwash (including chlorhexidine, lemon verbena and placebo). Necessary instructions and how to use are given to the patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
The three mouthwashes used in the study are packaged in exactly the same plastic bottles.Therefore, these mouthwashes can be masked in terms of shape. Therefore, the study is performed unknowingly in two ways and the patient and the dentist (evaluator) are masked.The treatment protocol used in the pilot research project is as follows:
The patient refers to the researcher (pharmacist) and is randomly assigned to one of the groups based on the codes. The researcher provides one of the mouthwashes to the patient based on the assigned code. The patient is referred to a study dentist and is prescribed by a dentist.After recording the results (efficiency), the results are provided to the person performing the data analysis (clinical pharmacist) in the form of code.Data analysis is performed without the knowledge of the person analyzing the type of mouthwash and the name of the patient, only based on the provided codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences_Mashhad faculty of dentistry
Street address
Mashhad faculty of dentistry, Vakil Abad Blv, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2020-10-21, 1399/07/30
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1400.043
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05.10
ICD-10 code description
Chronic gingivitis, plaque induced
Primary outcomes
1
Description
gingival index, plaque index, bleeding index
Timepoint
The beginning of the study (before the intervention) and 15 and 30 days after the start
Method of measurement
View and use the probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 20 patients should use lemon verbena mouthwash twice a day for 10 weeks, each time at 10 cc for 30 seconds, and avoid eating and drinking for half an hour after eating. The patient is also taught the correct method of brushing and hygiene education.
Category
Treatment - Drugs
2
Description
20 patients should use 0.2% chlorhexidine mouthwash twice a day for 10 weeks, each time at 10 cc for 30 seconds, and avoid eating and drinking for half an hour after eating. The patient is also taught the correct method of brushing and hygiene education.
Category
Treatment - Drugs
3
Description
Control group: 20 patients should use placebo mouthwash twice a day for 10 weeks, each time at 10 cc for 30 seconds, and avoid eating and drinking for half an hour after eating. The patient is also taught the correct method of brushing and hygiene education.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad faculty of dentistry
Full name of responsible person
Nahid Nasrabadi
Street address
Mashhad of faculty of dentistry, Vakil Abad Blv, Mashhad, Razavi khorasan province
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
nasran@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vice Chancellor for research of Mashhad University of Medical Sciences
Street address
Deputy of Technology and Research, Qureshi building, next to Hoveyze cinema, Daneshgah Avenue.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Nasrabadi
Position
َAssistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad faculty of dentistry, Vakil Abad Blv, Mashhad, Razavi khorasan province
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
nasran@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Nasrabadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad faculty of dentistry, Vakil Abad Blv , Mashhad, Razavi khorasan province
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
nasran@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Nasrabadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad faculty of dentistry, Vakil Abad Blv, Mashhad, Razavi khorasan province
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
Email
nasran@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data is related to the main consequence after unidentifiable people are shared
When the data will become available and for how long
6 month after printing the results.
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
If you are to submit a article to a journal, they will be asked to receive the data.
From where data/document is obtainable
Person responsible for scientific study. nasran@mums.ac.ir
What processes are involved for a request to access data/document
Sending an email to the given address and waiting time to receive a response less than a month.