Evaluation the effect of orthodontic adhesive containing titanium dioxide and chitosan nano-particles on mineral content and streptococcus mutans population in fixed orthodontic patients
Evaluation the effect of orthodontic adhesive containing titanium dioxide and chitosan nano-particles on mineral content and streptococcus mutans population in fixed orthodontic patients
Design
A randomized,double blinded, controlled clinical trial with parallel groups.
Settings and conduct
This clinical trial study will be conducted on 50 patients undergoing orthodontic treatment, who have been referred to orthodontic clinic of Mashhad Dental School (Responsible person: Dr.Fahimeh Farzanegan). Then,they will be randomly assigned to the case group and control group. In control group to attach the brackets, a light cure composite will be used.
In the case group, 5% by weight of titanium dioxide nanoparticles and 5% by weight nanocytosine will be added to the composite. After the set up, daily oral hygiene is recommendedthree times a day. Measurement of the enamel content and sampling for microbiological testing will be done at 24, 2, 6 months after bonding.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Orthodontic patients aged between 13-18 years undergoing fixed orthodontic treatment
Healthy gum
Upper second premolars and upper lateral incisors of the participants to be free of macroscopic enamel cracks, caries, or enamel hypoplasia.
Exclusion criteria:
Patients taking medications that cause xerostomia.
Systemic disease and active periodontal disease
Active caries on at least one tooth
Intervention groups
In the control group, light cure composite (Transbond XT, 3M, USA) will be used to bond brackets. In the case group, 5% by weight of titanium dioxide nanoparticles and 5% by weight nanocytosine will be added to the composite.
Main outcome variables
Number of streptococcal bacteria surrounding lateral brackets; Amount of mineral content of enamel
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180826040866N1
Registration date:2018-11-15, 1397/08/24
Registration timing:prospective
Last update:2018-11-15, 1397/08/24
Update count:0
Registration date
2018-11-15, 1397/08/24
Registrant information
Name
Fahimeh Farzanegan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 1796
Email address
farzaneganf@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of orthodontic adhesive containing titanium dioxide and chitosan nano-particles on mineral content and streptococcus mutans population in fixed orthodontic patients
Public title
Evaluation the efficacy of orthodontic adhesive containing titanium dioxide and chitosan nano-particles in fixed orthodontic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Orthodontic patients aged between 13-18 years undergoing fixed orthodontic treatment
Healthy gum
Upper second premolars and upper lateral incisors of the participants to be free of macroscopic enamel cracks, caries, or enamel hypoplasia.
Exclusion criteria:
Patients taking medications that cause xerostomia.
Systemic disease or active periodontal disease
Active caries on at least one tooth
Age
From 13 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization will be simple and will be accomplished using the table of random numbers. Allocation concealment will be achieved with
sequentially numbered, opaque, sealed envelopes containing the treatment allocation cards. Baseline information will be written on the outside before opening the envelope.
The project manager will be responsible for opening the next envelope in sequence and implementing the randomization process.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients do not know that they are in the control group or the intervention group and the composites used in tubes with the same and encoded shapes that the clinician does not know about. Finally, the sampling is also coded to allow the data analyzer to be blinded to the study.
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
Azadi Square, Mashhad Dental School
City
Mashhad
Province
Razavi Khorasan
Postal code
9185836393
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.050
Health conditions studied
1
Description of health condition studied
Demineralization of tooth enamel
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Population of Sterptococcus Mutans
Timepoint
24 hours, 2 months and 6 months after placing brackets
Method of measurement
Real-time polymerase chain reaction
Secondary outcomes
1
Description
ِDetermination of mineral context of enamel
Timepoint
24 hours, 2 months and 6 months after placing brackets
Method of measurement
Quantitative laser fluorescence technique
Intervention groups
1
Description
Intervention group: In this group, for bonding brackets the composite (Transbond XT, 3M, USA), which adds 5% by weight of titanium dioxide nanoparticles and 5% by weight of nanochitosan will be used.
Category
Prevention
2
Description
Control group: In this group, for bonding of brackets the composite (Transbond XT, 3M, USA) will be used.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dental School
Full name of responsible person
Fahimeh Farzanegan
Street address
Vakilabad blvd, Park Square, Mashhad Dental School
City
Mashhad
Province
Razavi Khorasan
Postal code
9185836393
Phone
+98 51 3882 9501
Email
farzaneganf@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research chancellor of Mashhad University of Medical Sciences, Daneshgah street no. 18
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
tafaghodim@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
Fahimeh Farzanegan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakilabad blvd, Park Square, Mashhad Dental School
City
Mashhad
Province
Razavi Khorasan
Postal code
9185836393
Phone
+98 51 3882 9501
Email
farzaneganf@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fahimeh Farzanegan
Position
َAssociate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakilabad blvd, Park Square, Mashhad Dental School
City
Mashhad
Province
Razavi Khorasan
Postal code
9185836393
Phone
+98 51 3882 9501
Email
farzaneganf@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fahimeh Farzanegan
Position
َAssociate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakilabad blvd, Park Square, Mashhad Dental School
City
Mashhad
Province
Razavi Khorasan
Postal code
9185836393
Phone
+98 51 3882 9501
Email
farzaneganf@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data of our tests will be available after deidentification.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Data is only available for people working in academic institutions
Under which criteria data/document could be used
Data is available for performing systematic reviews and meta analysis
From where data/document is obtainable
The applicant should send an mail to corresponding author(Fahimeh Farzanegan) to get the data files. farzaneganf@mums.ac.ir
What processes are involved for a request to access data/document
After sending email by applicant it will be replied until one week.