Comparing the effect of chlorhexidine(0.2%), matrica and persica mouthwashes on periodontal indices of children undergoing preventive orthodontic treatment
Determining the effect of three mouthwashes containing chlorhexidine (0.2%), Matrica and Persica on periodontal indices in children undergoing preventive orthodontic treatment
Design
Clinical trial without blinded group and crossover on 16 patients
Settings and conduct
16 children aged 8 to 12 years will be selected from patients of Dental School of Qazvin University of Medical Sciences who use mandible Lingual Arch appliance after presenting the necessary explanations written consent will be taken from the parents. Primary periodontal indices in these patients will then be measured. Chlorhexidine, Matrica, Persica mouthwashes will be used for a period of one week, respectively, after which GI and PI indices are measured on designed teeth.Candidates will be asked to brush their teeth 3 times as instructed.The mouthwash is gargled for 30 seconds half an hour after using a toothbrush and floss.After using the mouthwash, they dont wash their mouth and also dont eat anythings.avoid using toothpaste contaning fluoride for an hour before using mouthwashes. After each period, a wash-out time of 2 weeks is considered.
Participants/Inclusion and exclusion criteria
16 children 8 to 12 years old with lingual arch appliance in their mandible. Inclusion criteria: the patient's willingness to cooperate with research; dont suffer from diseases that weaken the immune system; ,do not suffer from various systemic diseases; do not receive antibiotics at least one month before and during the research period; do not use mouthwash in the past month; absence of periodontitis and do not receive periodontal treatment in the last 6 months. Exclusion criteria: sensitivity to mouthwashes; participants are reluctant to continue the process of using mouthwashes.
Intervention groups
All participants receive three type of mouthwashes (Chlorhexidine, Matrica, Persica)
Main outcome variables
Plaque index; gingivitis index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211114053060N1
Registration date:2021-12-19, 1400/09/28
Registration timing:prospective
Last update:2021-12-19, 1400/09/28
Update count:0
Registration date
2021-12-19, 1400/09/28
Registrant information
Name
Ali Naghipour Alamdari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4412 0178
Email address
a.naghipouralamdari@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2022-02-26, 1400/12/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of chlorhexidine(0.2%), matrica and persica mouthwashes on periodontal indices of children undergoing preventive orthodontic treatment
Public title
Comparing the effect of three types of mouthwashes on periodontal indices of children undergoing orthodontic treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient willingness to cooperate with research
Do not suffer from disease that weaken the immune system
Do not suffer from various systemic disease
Do not use mouthwash in the past month
Absence of periodontitis and receiving periodontal treatment in the last six months
Do not receive antibiotics at least one month before and during the study period
Exclusion criteria:
Sensitivity to mouthwashes
Participants are reluctant to continue the process of using mouthwashes
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Qazvin University Of Medical Sciences, Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3415759811
Approval date
2021-06-19, 1400/03/29
Ethics committee reference number
IR.QUMS.REC.1400.119
Health conditions studied
1
Description of health condition studied
Children undergoing preventive orthodontic treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plaque index
Timepoint
Beginning of research; 7 days after using each mouthwash with two-week washout period
Method of measurement
Sillness and loe with periodontal probe and mirror
2
Description
Gingival Index
Timepoint
Beginning of research; 7 days after using each mouthwash with two-week washout period
Method of measurement
Examination with periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 16Children 8 to 12 years old undergoing preventive orthodontic treatment 1.Matrica mouthwashes (Barij Essence Oil Company - 50 to 60 drops in half a glass of water, twice a day for 30 seconds), 2.Persica Mouthwashes (Poursina Company - 10 to 15 drops in 15 ml of water twice a day for 30 seconds) ) And 3.chlorhexidine mouthwash 0.2% (Iran Najo Company - 15 ml for 30 and twice a day, morning and night) and Subsequently, the individuals will be given one of the studied mouthwashes, and the volunteers will be asked to brush their teeth 3 times a day in the taught way.The mouthwash is gargled for 30 seconds half an hour after using the toothbrush and floss, and then it will be completely removed from the mouth. This operation will be repeated for up to seven days. The best time to use mouthwash will be at night before bed and in the morning after breakfast. After completing the first course and reviewing the indicators, people will not use any mouthwash for two weeks (as a wash-out period). Then , people enter a new phase of testing, which receives a different mouthwash from the first period, and the operation of the previous period will be repeated. After completing the second course and reviewing the indicators, the candidates enter the wash out course again for two weeks, after which the third study period begins. In this study, all people will be exposed to all three types of mouthwash.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School Of Qazvin University Of Medecal Sciences
Full name of responsible person
Ali Naghipour Alamdari
Street address
Dental Faculty, Qazvin University Of Medical Sciences, Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3415759811
Phone
+98 28 3335 3061
Fax
+98 28 3335 3066
Email
a.naghipouralamdari@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Seyed Mahdi Mirhashemi
Street address
Shahid Beheshti Blvd.
City
Qazvin
Province
Qazvin
Postal code
1391134156
Phone
+98 28 3333 7006
Email
sm.mirhashemi@qums.ac.ir
Web page address
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
Ali Naghipour Alamdari
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental Faculty, Qazvin University Of Medical Sciences, Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3415759811
Phone
+98 28 3335 3061
Fax
+98 28 3335 3066
Email
a.naghipouralamdari@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ali Naghipour Alamdari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental Faculty, Qazvin University Of Medical Sciences, Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3415759811
Phone
+98 28 3335 3061
Fax
+98 28 3335 3066
Email
a.naghipouralamdari@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ali Naghipour Alamdari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental Faculty, Qazvin University Of Medical Sciences, Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3415759811
Phone
+98 28 3335 3061
Fax
+98 28 3335 3066
Email
a.naghipouralamdari@qums.ac.ir
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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data containing the GI and PI of all participants can be shared after Unrecognizable individuals
When the data will become available and for how long
Start access after publishing the article
To whom data/document is available
everybody
Under which criteria data/document could be used
Start other researches
From where data/document is obtainable
ali naghipour alamdari/alinaghipour@yahoo.com
What processes are involved for a request to access data/document