Effect of toothpaste containing Bioactiveglass in remineralization of white spot lesion during fixed orthodontic treatment: A randomized clinical trial
To determine the effect of toothpaste containing bioactive glass on remineralization of white enamel lesions during orthodontic treatment.
Design
This study is a three-blind controlled randomized clinical trial with parallel groups on 38 patients using block randomization method.
Settings and conduct
This study is performed in the orthodontic department of Hamadan Dental School. At the initial visit, patients receive instructions for hygiene twice daily use of toothpaste
For each patient, the most severe white enamel lesion with the highest number of Diagnodent is evaluated and is evaluated by DIAGNOdent at the beginning, after one month and after three months. All tubes of toothpaste are covered by a blinding label. At the beginning of the study, a random number code is assigned to each patient And the researcher who makes the measurements and the statistical analyzer are blind
Participants/Inclusion and exclusion criteria
Inclusion criteria are: fixed orthodontic appellation on all teeth, remaining at least 3 months until the end of orthodontic treatment, having at least one white enamel lesion on the buccal surface of six anterior teeth and the first premolars in the upper or lower jaw. Exclusion criteria are: Oral or medical diseases
Intervention groups
Intervention group: Receiving toothpaste containing bioactive glass and using it twice a day for 3 months - Control group: Receiving toothpaste containing fluoride and using it twice a day for 3 months
Comparison of the effectiveness of bioactive glass in comparison with fluoride in improving the condition of primary enamel caries
Main outcome variables
Improves the remineralization rate of lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140215016582N5
Registration date:2021-01-24, 1399/11/05
Registration timing:registered_while_recruiting
Last update:2021-01-24, 1399/11/05
Update count:0
Registration date
2021-01-24, 1399/11/05
Registrant information
Name
Vahid Mollabashi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3835 2555
Email address
mollabashi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of toothpaste containing Bioactiveglass in remineralization of white spot lesion during fixed orthodontic treatment: A randomized clinical trial
Public title
The effect of bioactive glass toothpaste on improving the early stages of dental caries during fixed orthodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fixed orthodontic applique on all teeth
Remain at least 3 months until the end of fixed orthodontic treatment
Having at least one white enamel lesion on the buccal surface of six anterior teeth and the first premolars in the maxilla or mandible
Exclusion criteria:
Active dental caries
Active periodontal disease
Teeth with enamel defects
Teeth with internal and external discoloration such as fluorosis or tetracycline discoloration
Primary teeth
Facial-oral syndromes and cleft lip and palatal deformity
Patients under medical treatment or patients taking any type of medication
Age
From 15 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the block quantification method, it is divided into control group and study group by the researcher. The method of confiscation is that four blocks are used. If there are two treatments A and B, there are six different blocks as AABB, BBAA, ABAB, BABA, ABBA and BAAB. Random numbers between zero and one are now generated and the blocks are randomly selected based on random numbers. Thus, for numbers between 0 and 0.17, the first block, for numbers between 0.18 and 0.33, and the second block, for numbers between 0.34 and
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, patients are aware of the purpose of the study, which is to control white enamel lesions, but are blind to the product to be used in the study or to the group to which they belong. All tubes are covered by a blinding label. Assessments at all appointments are performed by an independent researcher who is blind to the groups. Statistical analysis is performed by a researcher who is blind to treatments.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Science
Street address
Shahid Fahmide Ave,
City
Hamadan
Province
Hamadan
Postal code
654178-38741
Approval date
2020-12-14, 1399/09/24
Ethics committee reference number
IR.UMSHA.REC.1399.763
Health conditions studied
1
Description of health condition studied
Enamel white lesions
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Change in white enamel lesions
Timepoint
At the beginning of the study and one month later and three months later
Method of measurement
Diagnodent laser device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving toothpaste containing bioactive glass. In this group, the amount of tooth mineralization is first determined using a diagnostic laser made by the German company Kavo. Patients are then given toothpaste containing the bioactive glass (sensodyne, powered by Novamin) in a white tube without specifications and patients are instructed twice a day with a certain amount of toothpaste (about the size of a pea) for Brush their teeth for two minutes in 3 months. The amount of mineralization of the tooth is measured by the diagnostic device one and three months later
Category
Treatment - Other
2
Description
Control group: Patients receiving fluoride toothpaste. In this group, the amount of tooth mineralization is first determined using a diagnostic laser made by the German company Kavo. Fluoride toothpaste (sensodyne, Rapid Relief) is then given to patients in a white tube without specifications and patients are instructed to take a certain amount of toothpaste (about the size of a pea) twice a day for two minutes. Brush their teeth for 3 months. The amount of mineralization of the tooth is measured by the diagnostic device one and three months later
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Orthodontics, Hamadan Dental School
Full name of responsible person
Maryam Heydarpour
Street address
Shahid Fahmide
City
Hamadan
Province
Hamadan
Postal code
654178-38741
Phone
+98 81 3838 1059
Fax
+98 81 3838 1085
Email
Dentistry@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeed Bashirian
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
654178-38741
Phone
+98 81 3838 1059
Email
dentistry@umsha.ac.ir
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
Maryam Heydarpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
654178-38741
Phone
+98 81 3838 1059
Email
Maryamheydarpour97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Heydarpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
654178-38741
Phone
+98 81 3838 1059
Email
Maryamheydarpour97@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Heydarpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
654178-38741
Phone
+98 81 3838 1059
Email
Maryamheydarpour97@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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual data includes demographic characteristics and original outcome information are shared
When the data will become available and for how long
Start the access period starts 6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutes and companies producing toothpaste
Under which criteria data/document could be used
Unidentifiable information will not be provided due to the type of consent given to patients and the obligation of the investigator to comply with ethical requirements.
From where data/document is obtainable
Maryam Haidarpour: corresponding author, Maryamheydarpour @ gmail.com
Vahid Malabashi: First author, mollabashi@umsha.ac.ir
What processes are involved for a request to access data/document
After result publication through electronic E Mail of corresponding author and complete introduction and mention the goal from having the documentation, within a maximum one week related file is available to the applicant