Evaluation of the effect of brackets coated with titanium dioxide nanoparticles in the prevention of dental enamel demineralization and the amount of titanium release in the oral environment during the treatment of fixed orthodontic patients: a randomized controlled clinical trial
Determining the effect of brackets coated with titanium dioxide nanoparticles in water on the demineralization of tooth enamel and the amount of saliva release in the oral environment during the treatment of fixed orthodontic patients.
Design
Clinical trial with a single-blind, randomized phase 0 control group on 48 patients. To determine the intervention and control groups, pre-prepared cards were drawn from the box by lot.
Settings and conduct
This study will be conducted by orthodontic assistants in the orthodontic department of Hamedan University of Medical Sciences. One maxillary lateral tooth in one person will be randomly selected as a control and one lateral tooth in another person as an intervention, and brackets coated with nanoparticles will be placed on the teeth of the intervention group. The bonding therapist and the participants are unaware of the intervention and control groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: Fixed orthodontic treatment candidates who are 15–25-year-old with upper lateral teeth, without cracks, demineralization.
Exclusion criteria: patients who have lost their teeth due to caries.
Intervention groups
One maxillary lateral tooth in one person is randomly bonded with brackets coated with nanoparticles. In the control group, one maxillary lateral tooth is randomly bonded with a normal orthodontic bracket (without nanoparticles). Two groups of 0/022 inch MBT system bracket (American brand) will be used.
Main outcome variables
Demineralization of dental enamel
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140215016582N7
Registration date:2024-01-08, 1402/10/18
Registration timing:prospective
Last update:2024-01-08, 1402/10/18
Update count:0
Registration date
2024-01-08, 1402/10/18
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
2024-01-20, 1402/10/30
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of brackets coated with titanium dioxide nanoparticles in the prevention of dental enamel demineralization and the amount of titanium release in the oral environment during the treatment of fixed orthodontic patients: a randomized controlled clinical trial
Public title
Effect of brackets coated with nanoparticles in the prevention of dental enamel demineralization
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient ranged 15-25 years old
The ability to observe the hygiene of mouth
They must have 1-4 repaired yeeth
A healthy and flawless immune system
Non-use of antibiotics and antibacterial during treatment
Exclusion criteria:
Tooth loss due to decay
The presence of active caries or prosthetic treatment in the mouth
Smoking
Periodontal disease
Treated with immunosuppressive drugs
People with diabetes
Pregnancy
Age
From 15 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
In this study simple randomization method will be used.24 cards with a/b code and 24 cards with b/a code will be provided in a box, in which the patient will randomly select from. the codes' key is with the first investigator.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants, the therapists who bond the brackets, the researcher who measures the diagnodent number, and the analyzing researcher are unaware of the group assignment.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan university of medical sciences
Street address
ُShahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-11-25, 1402/09/04
Ethics committee reference number
IR.UMSHA.REC.1402.557
Health conditions studied
1
Description of health condition studied
Caries and demineralization
ICD-10 code
K02.61
ICD-10 code description
Dental caries on smooth surface limited to enamel
Primary outcomes
1
Description
Tooth demineralization
Timepoint
Before the intervention, one month and three months after the intervention
Method of measurement
Diagnodent device
Secondary outcomes
1
Description
The amount of titanium in saliva
Timepoint
Before the intervention, one month and three months after the intervention
Method of measurement
ICP MS device
Intervention groups
1
Description
Intervention group: Intervention group: tooth bond with bracket coated by titanium dioxide nanoparticles with vapor deposition method
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan university of medical sciences
Full name of responsible person
Behrooz Khodabandehloo
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3252 0182
Email
Webda@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 Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1059
Email
Webda@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research and Technology, Hamedan University of Medical Science
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
Behrooz Khodadandehloo
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmideh
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
0098 81 8216072
Email
Velayateallah@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behrooz Khodabandehloo
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
0098 81 8216072
Email
Velayateallah@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behrooz Khodabandehloo
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
0098 81 8216072
Email
Velayateallah@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
Not applicable
Title and more details about the data/document
Some data such as information on the main outcome
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
For same study designs
From where data/document is obtainable
velayateallah@gmail.com
00989187029713
What processes are involved for a request to access data/document
The study will last about 6 months and then the result will be published in the form of an article 2 months later.