Comparison of effectiveness between Aloe vera and chlorhexidine 0.2% mouthwash on gingival health
Design
This study is a randomized clinical trial with a control group as a parallel design. This randomized, double-blinded study will be conducted on 26 eligible patients. A simple random method is used for randomization and the participants are assigned to two intervention groups and one control group.
Settings and conduct
This study, which will be conducted in the Faculty of Dentistry of Isfahan Azad University, is double-blinded. 14 days before the start of the study, all the samples are given the same toothbrush and toothpaste, and they are advised to brush twice a day after breakfast and before going to bed for three minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; People undergoing fixed orthodontic treatment at least two weeks after band brackets; Age between 15-35 years;Proper oral hygiene
Exclusion criteria: Suffering from systemic diseases such as chronic liver diseases, blood diseases, diabetes, etc. Smoking, hookah, or pipe at least once a week; Simultaneous suffering from psychological or neurological diseases such as psychosis, multiple sclerosis (MS), and bipolar disorder ;Taking drugs that reduce the flow of saliva; Suffering from genetic syndromes
Intervention groups
The first intervention group will receive aloe vera mouthwash twice a day after breakfast and before bed for 4 weeks. The second intervention group will receive 10 ml of common 0.2% chlorhexidine mouthwash 2 times a day after breakfast and before bed for 4 weeks. The control group will receive distilled water twice a day after breakfast and before bed for 4 weeks.
Main outcome variables
Gum index, plaque index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N220
Registration date:2024-07-10, 1403/04/20
Registration timing:registered_while_recruiting
Last update:2024-07-10, 1403/04/20
Update count:0
Registration date
2024-07-10, 1403/04/20
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness between Aloe vera and chlorhexidine 0.2% mouthwash on gingival health and plaque formation in fixed orthodontics patients
Public title
Comparison of effectiveness between Aloe vera and chlorhexidine 0.2% mouthwash on gingival health
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
People undergoing fixed orthodontic treatment at least two weeks after band brackets
Age between 15-35 years
Proper oral hygiene
Exclusion criteria:
Suffering from systemic diseases such as chronic liver diseases, blood diseases, diabetes, etc.
Smoking, hookah, or pipe at least once a week
Simultaneous suffering from psychological or neurological diseases such as psychosis, multiple sclerosis (MS), bipolar disorder
Taking drugs that reduce the flow of saliva
Suffering from genetic syndromes
Age
From 15 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Using the simple random method. The names of the participants are written on the card. The cards are put into a box that cannot be seen outside. One of the colleagues of the plan is asked to take one card from the container at a time. The names of the 12 cards selected are placed in the first intervention group, the second 12 in the second intervention group, and the remaining 12 in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Mouthwashes are given to patients in opaque bottles and all bottles are mint flavored. Mouthwashes can only be identified through the serial number on the container. The serials are with the main researcher and will remain confidential until the end of 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 Isfahan Islamic Azad University (Khorasgan)
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2024-04-21, 1403/02/02
Ethics committee reference number
IR.IAU.KHUISF.REC.1403.021
Health conditions studied
1
Description of health condition studied
Gingival health
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Gum index
Timepoint
Days 0, 14 and 28
Method of measurement
Using a Williams probe and a mirror
2
Description
Plate index
Timepoint
Days 0, 14 and 28
Method of measurement
Using a Williams probe, a mirror and a plate detector tablet
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive aloe vera mouthwash twice a day after breakfast and before bed for 4 weeks. The second intervention group will receive 10 ml of common 0.2% chlorhexidine mouthwash 2 times a day after breakfast and before bed for 4 weeks.
Category
Treatment - Drugs
2
Description
The second intervention group will receive 10 ml of common 0.2% chlorhexidine mouthwash 2 times a day after breakfast and before bed for 4 weeks.
Category
Treatment - Drugs
3
Description
The control group will receive distilled water twice a day after breakfast and before bed for 4 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Azad University of Isfahan
Full name of responsible person
Dr. Mehdi Rafiei
Street address
University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
e.rafiei@khuisf.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khorasan Azad University, Isfahan branch
Full name of responsible person
Dr. Majid Meshkini
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
meshkini@miums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khorasan Azad University, Isfahan branch
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
Khorasan Azad University, Isfahan branch
Full name of responsible person
Dr. Mehdi Rafiei
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Orthodontics
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
mehdi.rafiei@khuisf.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khorasan Azad University, Isfahan branch
Full name of responsible person
Dr. Mehdi Rafiei
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Orthodontics
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
mehdi.rafiei@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Khorasan Azad University, Isfahan branch
Full name of responsible person
Dr. Mehdi Rafiei
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Orthodontics
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
mehdi.rafiei@khuisf.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD