Comparison of the effectiveness of shallomin II and chlorhexidine mouthwashes in treating plaque induced gingivitis: A clinical trial and microbiologic study
Comparison of the effectiveness of shallomin II and chlorhexidine mouthwashes in treating plaque induced gingivitis: A clinical trial and microbiologic study
Design
The study is a parallel double-blind study. Randomization and assignment of patients to each of the two groups is done by the nurse. Two mouthwashes in the same packaging are offered to 36 patients, and the patients, presenters, and students are not aware of the type of mouthwash. The data will be analyzed by SPSS software version 22.
Settings and conduct
36 patients with gingivitis referred to the periodontology department of the Faculty of Dentistry, Jundishapur University of Medical Sciences, Ahvaz
Participants/Inclusion and exclusion criteria
1. Systemically healthy
2. The presence of more than 20 permanent teeth (except the third molar)
3. Untreated gingivitis (gingival index greater than 1 (2 or more), probing depth less than equal to 3, no clinical attachment loss, no evidence of radiographic bone loss.)
4. The percentage of areas with bleeding during probing should be more than 30%.
5. Not using antibiotics and anti-inflammatory drugs in the last three months
6. Not using any mouthwash in the last month.
7. Not using fixed orthodontic devices or prosthetics that interfere with the evaluation.
8. Not using cigarettes and alcohol
9. Do not have mental retardation
10. Do not be pregnant or breastfeeding.
Exclusion criteria
1. Allergy to chlorhexidine and Shalomin II
2. Any pathology in the oral mucosa
3. Acute gingivitis
Intervention groups
Shalomin II herbal mouthwash: mouthwash derived from Iranian shallot, 5 ml twice a day for 30 seconds each time for two weeks
Chlorhexidine mouthwash 0.2%: 5 ml each time and twice a day for 30 seconds each time for two weeks.
Main outcome variables
Quigley-Hein Plaque Index؛ Gingival index؛ Total colony count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230305057627N1
Registration date:2023-04-17, 1402/01/28
Registration timing:prospective
Last update:2023-04-17, 1402/01/28
Update count:1
Registration date
2023-04-17, 1402/01/28
Registrant information
Name
Neda Samie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 5168
Email address
samie-n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of shallomin II and chlorhexidine mouthwashes in treating plaque induced gingivitis: A clinical trial and microbiologic study
Public title
Comparison of the effectiveness of shallomin II and chlorhexidine mouthwashes in treating plaque induced gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Systemically healthy
The presence of more than 20 permanent teeth (except the third molar)
Untreated gingivitis (gingival index greater than 1 (2 or more), probing depth less than equal to 3, no clinical attachment loss, no evidence of radiographic bone loss.)
The percentage of areas with bleeding during probing should be more than 30%
Not using antibiotics and anti-inflammatory drugs in the last three months
No mouthwash has been used in the past month
Do not use cigarettes or alcohol
Do not have mental retardation
Not during pregnancy or breastfeeding
Exclusion criteria:
The presence of any pathology in the oral mucosa
Acute gingivitis
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
In this study the randomization will be done using random numbers table. After consultation with the statistics specialist even numbers will be considered for the intervention group and odd numbers for control group. The researcher stays on one of the numbers then the right direction which predefined to move and the numbers will be registered.
Blinding (investigator's opinion)
Double blinded
Blinding description
Shallomin mouthwash will be made with the taste and color of used chlorhexidine mouthwash. Both mouthwashes are put in the same bottles and coded (code 1 and 2). All coded bottles are placed in exactly the same packaging. The examiner will give each patient a package without knowing the meaning of each code and the type of bottle in each package, and after opening the package, the bottle code of each patient will be noted. During the study, the examiner and the patients will not know the type of mouthwash used. Meanwhile, patients are aware of participating in the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Jundishapur University, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2023-02-06, 1401/11/17
Ethics committee reference number
IR.AJUMS.REC.1401.519
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
Timepoint
At the beginning of study, seventh day and fourteenth day
Method of measurement
Using a periodontal probe
2
Description
Quigley-Hein Plaque Index
Timepoint
At the beginning of study, seventh day and fourteenth day
Method of measurement
Using disclosing tablets
3
Description
Total colony count
Timepoint
At the beginning of study, seventh day and fourteenth day
Method of measurement
Counting and recording
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 18 patients should use Shallomin II mouthwash twice a day for 2 weeks, each time at 5 cc for 30 seconds, and avoid eating and drinking for 30 to 45 minutes. The patient is also taught the correct method of brushing and hygiene education.
Category
Treatment - Drugs
2
Description
Intervention group: 18 patients should use 0.2% chlorhexidine mouthwash twice a day for 2 weeks, each time at 5 cc for 30 seconds, and avoid eating and drinking for 30 to 45 minutes. The patient is also taught the correct method of brushing and hygiene education.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Jundishapur Dental School
Full name of responsible person
Neda Samie
Street address
Dental School, Dey Ave, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5168
Email
samie-n@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Dental School, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Kaviani Nezhad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental School, Dey Ave, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3376 5825
Email
rezakv999@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Samie
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Jundishapur Dental School, Dey Ave, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3376 5825
Email
samie-n@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Kaviani Nezhad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Jundishapur Dental School, Dey Ave, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3376 5825
Email
rezakv999@gmail.com
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
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
Title and more details about the data/document
Part of the data, such as information about the main outcome, can be shared.
When the data will become available and for how long
Access starts 6 months after the results are published.
To whom data/document is available
Only for researcher working in academic and scientific institutions
Under which criteria data/document could be used
There are no conditions and all colleagues can use all the data