Evaluating the effectiveness of water and liquid soap solution compared to chlorhexidine on microbial load reduction and microbial plaque formation on orthodontic removable appliances
The aim of this study is to determine the effectiveness of water and liquid soap solution in comparison with chlorhexidine in reducing microbial load and microbial plaque formation on orthodontic removable appliances in order to describing water and liquid soap solution which is easy to access, low cost and has no destructive effects on the appliances for the patients based on scientific documentation.
Design
a cross, one-way blinded, randomized clinical trial without control group. For randomization R software version 3.4.3 is used.
Settings and conduct
This one-way blinded clinical trial (blinding of this study is done with R software version 3.4.3, and the patients are not aware of the solution used to wash the appliances) is conducted in Guilan dental school on 20 patients within the age of 6 to 19 candidate for treatment with orthodontic removable appliances. Sampling is done with 1 week distance, the patients should not use any specific solution on the appliances.
Participants/Inclusion and exclusion criteria
20 patients who are candidate for treatment with maxillary removable orthodontic appliances referred to Guilan dental school and private office regardless of gender and in the age range of 9 to 16 will be selected.
Intervention groups
The intervention in this study includes washing the orthodontic removable appliances with water and liquid soap solution and chlorhexidine solution.
Main outcome variables
Proving the effectiveness of water and liquid soap solution and its comparability with chlorhexidine in reducing microbial load on orthodontic removable appliances.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190915044771N1
Registration date:2020-08-26, 1399/06/05
Registration timing:prospective
Last update:2020-08-26, 1399/06/05
Update count:0
Registration date
2020-08-26, 1399/06/05
Registrant information
Name
Yasamin Babaee hemmati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3332 0298
Email address
yasi.10482@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-21, 1399/06/31
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of water and liquid soap solution compared to chlorhexidine on microbial load reduction and microbial plaque formation on orthodontic removable appliances
Public title
evaluating the effectiveness of water and liquid soap solution in cleansing of orthodontic removable appliances
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
patients with good general health and good oral hygiene candidate receiving treatment with orthodontic removable appliances
Exclusion criteria:
patients with sever crowding
wide diastema
periodontal problems
severe dental caries or cavities
patients using antimicrobial mouthwashes
patients who have received antibiotics in last three months
patients with poor oral hygiene
Age
From 9 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
7
The samples are included of samples with sterile swab from patient's palate in each session to determine the index of microbial plaque in the patient and the samples taken from the surface of orthodontic removable appliances before and after the appliance wash at the first session of referral(7 days from beginning) and the second meeting(14 days from beginning).
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation rule is used to assign individuals to two groups. For this reason, considering group A the removable appliances are located in water and liquid soap solution and in group B the removable appliances are located in chlorhexidine solution. Randomization was performed with R software version 3.4.3.
Blinding (investigator's opinion)
Single blinded
Blinding description
performing the washing steps in each visit are done by a trained person and according to the designated protocol and the patient is not aware of the solution for washing, so it is an one-way blind study
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commiittee of Guilan University of Medical Sciences
Street address
No. 20, Faraz building, Fajr Alley, Namjoo Ave
City
Rasht
Province
Guilan
Postal code
4144693358
Approval date
2020-07-28, 1399/05/07
Ethics committee reference number
IR.GUMS.REC.1399.224
Health conditions studied
1
Description of health condition studied
Evaluating the effectiveness of water and liquid soap solution compared to chlorhexidine on microbial load reduction and microbial plaque formation on orthodontic removable appliances
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
microbial load on orthodontic removable appliance
Timepoint
7 days from beginning, 14 days from beginning
Method of measurement
Stained areas with disclosing agents
2
Description
microbial load on orthodontic removable appliance
Timepoint
7 days from beginning, 14 days from beginning
Method of measurement
Counting the number of live bacteria
Secondary outcomes
1
Description
Patient's plaque index
Timepoint
At the beginning of study (orthodontic removable appliance delivery session), 7 days from beginning, 14 days from beginning
Method of measurement
Counting the number of live bacteria
Intervention groups
1
Description
Intervention group A : In first referral session the orthodontic removable appliances will be washed with water and liquid soap solution, and in the second session the appliances will be washed with chlorhexidine 0.2%.
Category
Other
2
Description
Intervention group B : Group A interventions for this group will be done in reverse.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Guilan dental school
Full name of responsible person
Dr. Yasamin Babaee hemmati
Street address
Guilan dental school, Fuman, Guilan Province
City
Rasht
Province
Guilan
Postal code
4144693358
Phone
+98 13 3348 6406
Email
yasi.10482@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammadreza Naghipour
Street address
Guilan University of Medical Sciences, Tehran highway ,Guilan Province
City
Rasht
Province
Guilan
Postal code
4144693358
Phone
+98 13 3348 6406
Email
yasi.10482@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
50
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
Rasht University of Medical Sciences
Full name of responsible person
Dr. Yasamin Babaee Hemmati
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthodontist
Street address
Guilan dental school, Rasht
City
Rasht
Province
Guilan
Postal code
4144693358
Phone
+98 13 3348 6406
Email
yasi.10482@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Yasamin Babaee hemmati
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.12,Banafshe Ave,Manzarieh Blvd,Rasht
City
Rasht
Province
Guilan
Postal code
4144693358
Phone
+98 13 3332 0298
Fax
Email
yasi.10482@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Yasamin Babaee hemmati
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Orthodontist
Street address
No.12,Banafshe Ave,Manzarieh Blvd,Rasht
City
Rasht
Province
Guilan
Postal code
4144693358
Phone
+98 13 3332 0298
Fax
Email
yasi.10482@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data in this study can be shared.
When the data will become available and for how long
The beginning of the access period is after 1401
To whom data/document is available
The data of this study will be available for use by other researchers.
Under which criteria data/document could be used
In the case of using the results and methods of this study, the source should be mentioned.
From where data/document is obtainable
Dr. Yasamin Babaee Hemmati, Guilan dental school
What processes are involved for a request to access data/document
Review and satisfaction of the person responsible for the implementation of this study.