Evaluating the microbial plaque removing effect of three methods of brushing and using brush and dentipur tabs and using brush and propolis mouthwash together for cleaning removable orthodontic appliances
ٍEvaluating the microbial plaque removing effect of three methods of brushing and using brush and dentipur tabs together and using brush and propolis mouthwash together for cleaning removable orthodontic appliances
Design
A cross over randomized clinical trial with control group, enrolled between April 2019 and August 2019.
Settings and conduct
This study is designed in dental faculty of Hamadan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Removable orthodontic patients who have completely obeyed the instructions regarding appliance wear and oral hygiene and who have less than 30 plaque index. Patients who had systemic or immunodeficient disease would be excluded.
Intervention groups
Control group: brushing the orthodontic appliance for cleansing purpose Intervention group: brushing and using dentipur tablet for cleansing orthodontic appliance and brushing and using propolis mouthwash
Main outcome variables
The area of orthodontic appliance which have microbial plaque.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190106042253N2
Registration date:2019-03-07, 1397/12/16
Registration timing:prospective
Last update:2019-03-07, 1397/12/16
Update count:0
Registration date
2019-03-07, 1397/12/16
Registrant information
Name
Homa Farhadifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3835 4250
Email address
homa.far1989@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the microbial plaque removing effect of three methods of brushing and using brush and dentipur tabs and using brush and propolis mouthwash together for cleaning removable orthodontic appliances
Public title
Cleansing effect of dentipur and brushing and propolis mouthwash for removable orthodontic appliances
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Full time wear of orthodontic appliance
Tooth brushing with medium hardness brush and bass technique 3 times per day
Plaque index lower than 30
One month of complete compliance with appliance wear and hygienic instruction regarding brushing the appliance
age between 7-15 years old
Exclusion criteria:
Presence of systemic or immunodeficient diseases
Poor compliance of appliance wear
Poor compliance of hygienic instructions
Age
From 7 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
This study is designed as crossover. Each patient is allocated to each group in randomized and sequential order. Simple randomization was done with individual unit of randomization. Patient allocation and allocation concealment was conducted with numbers in sealed and opaque pockets.
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 Hamadan university of medical sciences
Street address
Shahid fahmide avenue
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2018-11-03, 1397/08/12
Ethics committee reference number
IR.UMSHA.REC.1397.513
Health conditions studied
1
Description of health condition studied
Presence of microbial plaque on orthodontic appliance
ICD-10 code
B95.4
ICD-10 code description
Other streptococcus as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Area of orthodontic removable appliance covered with microbial plaque.
Timepoint
Before intervention, 1 month after brushing, 1 month after combined use of brush and dentipur tablet and 1 month after combined use of brush and propolis mouthwash
Method of measurement
Microbial plaque is revealed by disclosing agent. Then a photograph is taken from orthodontic appliance and the area of disclosed region is calculated by aid of Image J software.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: combined use of dentipur tablet (Helago-Pharma GmbH, Germany) and brush: patient floats his/her appliance in a solution including 1 dentipur tab + 200cc water for 3 minutes, then brushes the appliance, every night for 1 month.
Category
Prevention
2
Description
Intervention group: combined use of propolis mouthwash(30%extract,SorenTektoos,Mashhad) and brush: patient floats his/her appliance in a solution including 1 bushel (special for mouthwash) + 200cc water for 3 minutes, then brushes the appliance every night for 1 month.
Category
Prevention
3
Description
Control group: using brush: patient cleans his/her appliance with tooth brush (without toothpaste) every night for 1 month.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental faculty of Hamadan university
Full name of responsible person
Homa Farhadifard
Street address
Fahmide avenue
City
Hamadan
Province
Hamadan
Postal code
654178-38741
Phone
+98 81 3838 1059
Email
Homa.far1989@gmail.com
2
Recruitment center
Name of recruitment center
Hamadan university dental clinic
Full name of responsible person
Homa farhadifard
Street address
Felestin squar
City
Hamadan
Province
Hamadan
Postal code
65176-59114
Phone
+98 81 3423 8989
Email
Homa.far1989@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Fahmide avenue
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0717
Email
S_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Homa Farhadifard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Fahmide Blvd.
City
Hamadan
Province
Hamadan
Postal code
65178-38677
Phone
+98 81 3835 4250
Fax
Email
homa.far1989@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Homa Farhadifard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Fahmide Blvd.
City
Hamadan
Province
Hamadan
Postal code
65178-38677
Phone
+98 81 3835 4250
Fax
Email
homa.far1989@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Homa Farhadifard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Fahmide Blvd.
City
Hamadan
Province
Hamadan
Postal code
65178-38677
Phone
+98 81 3835 4250
Fax
Email
homa.far1989@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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 collected data would be shared without patients name or identification data
When the data will become available and for how long
starting in 2020
To whom data/document is available
Academic institution
Under which criteria data/document could be used
The data can be used in larger, multicenter studies.
From where data/document is obtainable
Researchers can assess data by emailing at homa.far1989@gmail.com.
What processes are involved for a request to access data/document
After emailing the request for data, the data would be sent in 1 week to the researcher.