Protocol summary
-
Study aim
-
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 (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
-
Plaque Index(Loe & Sillness)؛ Gingival index(Sillness & loe) ؛Total colony count
General information
-
Reason for update
-
Editing indicators and entry criteria.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20230305057627N1
Registration date:
2023-04-17, 1402/01/28
Registration timing:
prospective
Last update:
2023-10-16, 1402/07/24
Update count:
1
-
Registration date
-
2023-04-17, 1402/01/28
-
Registrant information
-
-
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 (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
-
Ethics committees
1
-
Ethics committee
-
-
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 (Sillness & loe)
-
Timepoint
-
At the beginning of study, seventh day and fourteenth day
-
Method of measurement
-
Using a periodontal probe
2
-
Description
-
Plaque Index (Loe & Sillness)
-
Timepoint
-
At the beginning of study, seventh day and fourteenth day
-
Method of measurement
-
Using a periodontal probe
3
-
Description
-
Total colony count
-
Timepoint
-
At the beginning of study, seventh day and fourteenth day
-
Method of measurement
-
Counting and recording
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
1
-
Sponsor
-
-
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
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
-
From where data/document is obtainable
-
Reza Kaviani Nezhad, Email adress: rezakv999@gmail.com
-
What processes are involved for a request to access data/document
-
Finally one week after requesting data or documentation
-
Comments
-