To compare the effectiveness of ordinary toothpaste with fluorescein toothpaste on plaque control in fixed orthodontic patients
Design
Totally, 40 patients whose undergoing fixed orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, Mashhad, Iran. In this single-blind, controlled clinical trial, the patients are assigned into parallel groups using simple sampling methods.
Settings and conduct
Patients whose undergoing orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least 12 years; physical health conditions; no having tooth decay; no having soft tissue diseases; having fixed orthodontic appliances in both the upper and lower jaws. Exclusion criteria: Having food coloring allergies; using antibiotics for two weeks before.
Intervention groups
The intervention group will receive ordinary toothpaste for a month and then fluorescein toothpaste as well as ultraviolet light device. The patients were requested to identify the spots of the remaining plaques with LED light in a semi-dark room after each brushing and clean them again with a toothbrush in two months. The control group will receive ordinary toothpaste for 2 months.
Main outcome variables
Evaluation and comparison of the orthodontic plaque index and bleeding point index one and two months after intervention in control and intervention groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200509047355N1
Registration date:2020-05-30, 1399/03/10
Registration timing:prospective
Last update:2020-05-30, 1399/03/10
Update count:0
Registration date
2020-05-30, 1399/03/10
Registrant information
Name
Masume Charbgoo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4722 2195
Email address
charbgoum941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of ordinary toothpaste with fluorescein toothpaste on plaque control in fixed orthodontic patients
Public title
The effectiveness fluorescein toothpaste on plaque control in fixed orthodontic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
At least 12 years
Physical health conditions
No having tooth decay
No having soft tissue diseases
Having fixed orthodontic appliances in both the upper and lower jaws
Exclusion criteria:
Having food coloring allergies
Using antibiotics for two weeks before
Age
From 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly assigned into three groups of 20 patients with blocks of 2 and 4 using randomization method. A noninvolved researcher will determine the random assignment sequencing in sampling using a statistical analysis system (SAS), computer software. Accordingly, the participants were given codes and assigned into the intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients whose undergoing orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2020-04-27, 1399/02/08
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1399.001
Health conditions studied
1
Description of health condition studied
Orthodontic
ICD-10 code
Z46.4
ICD-10 code description
Fitting and adjustment of orthodontic device
Primary outcomes
1
Description
Orthodontic plaque index
Timepoint
One and two months after intervention
Method of measurement
Staining the teeth or surfaces with a plaque-disclosing solution such as erythrosine
2
Description
Bleeding point index
Timepoint
One and two months after intervention
Method of measurement
During the examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive ordinary toothpaste for a month and then fluorescein toothpaste as well as ultraviolet light device. The patients were requested to identify the spots of the remaining plaques with LED light in a semi-dark room after each brushing and clean them again with a toothbrush in two months.
Category
Prevention
2
Description
Control group: The control group will receive ordinary toothpaste for 2 months.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry Dental Clinic
Full name of responsible person
Masume Charbgoo
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
charbgouM941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Masume Charbgoo
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
charbgouM941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masume Charbgoo
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
charbgouM941@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masume Charbgoo
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
charbgouM941@mums.ac.ir
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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome or the like can be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working at science centers and universities.
Under which criteria data/document could be used
Our data will be available for scholars working at science centers and universities.
From where data/document is obtainable
Masume Charbgoo provides the data analysis to the applicants via email: charbgouM941@mums.ac.ir
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.