The purpose of this study was to investigate the effect of stainless steel wire coating with titanium oxide on Streptococcus mutans adhesion in patients undergoing orthodontic treatment.
Design
Clinical trial with control group, with parallel group, double-blind, block randomization with a sample size of 68 persons (4 groups of 17 persons)
Settings and conduct
This clinical trial will be done in Orthodontic department of Hamadan University on 68 patients. In this study one arch is case and the opposite arch is considered as control group. Stainless steel arch wires coated with Titanium oxide are used in the case groups and conventional Stainless steel arch wires are placed in control groups. Double blinding for patients and postoperative care is done.
Participants/Inclusion and exclusion criteria
This study will be done in Orthodontic department of Hamadan University of Medical Sciences. Inclusion criteria are: 1) age range between 12 to 25 years old 2) don't use antibiotic and oral mouth wash during orthodontic treatment 3) no history of systemic disease 4) no smoking 5) don't use intra arch elastic, chain , O- ring and open coil during treatment . exclusion criteria are: 1) missing,orofacial syndroms and craniofacial anomalies 2) pregnant women 3) Diabetes, AIDS and immuno- suppressive drug users
Intervention groups
In this study orthodontics arch wires coated with titanium oxide are placed randomly in one of upper or lower arch and opposite arch is considered as control group.Patients are divided into 4 groups (A, B, C, D). Intervention in each group is as follows: Group A: exit of the wire from the mouth after one week, Group B: exit of the wire after two weeks, group c : exit the wire after three weeks and group D:exit the wire after four weeks.
Main outcome variables
Decreasing of cariogenic bacteries adhesion by using antiadhrent characteristic of titanium oxide coating
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140215016582N3
Registration date:2019-07-03, 1398/04/12
Registration timing:prospective
Last update:2019-07-03, 1398/04/12
Update count:0
Registration date
2019-07-03, 1398/04/12
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
2019-08-22, 1398/05/31
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of streptococcus mutans adhesion on stainless steel orthodontic wire caoted with titanuim oxide in orthodontic patients
Public title
Effect of titanuim oxide coating on streptococcus mutans adhesion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referring to Hamadan Dental School
Age ranged 12-25 years old
Non-use of antibacterial mouthwashes and antibiotics during treatment
Non-use of interarch elastics,chain,O-ring and open coil during treatment
Exclusion criteria:
The presence of systemic diseases such as : diabetes, AIDS and consumers of immunosuppressive drugs
Pregnancy
Smoking
The presence of dental missing, syndroms and craniofacial anomalies
Age
From 12 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
68
More than 1 sample in each individual
Number of samples in each individual:
2
Orthodontic arch wires in upper and lower arch
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a block randomization method is used. Group name (A, B, C, D) is written on the 4 cards and the first patient chooses one of them. The next patient chooses one of the three remaining cards, the next patient will be assigned one of the two cards and the last card allocated to the fourth patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are unaware of wires(coated or non-coated) located in the upper or lower jaw, and also, the person who evaluates the outcome is blinded.
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 Sciences
Street address
Shahid Fahmide Ave., Hamadan university of Medical science
City
Hamadan
Province
Hamadan
Postal code
65178-38677
Approval date
2019-01-26, 1397/11/06
Ethics committee reference number
IR.UMSHA.REC.1397.791
Health conditions studied
1
Description of health condition studied
Streptococcus mutans adhesion to orthodontic wire
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Streptococcus mutans adhesion to orthodontic wires
Timepoint
Bacterial counting in 4 groups with 1 to 4 weeks interval
Method of measurement
Colony count
Secondary outcomes
1
Description
Evaluation of anti-adherent property of coated wire during the time
Timepoint
Aftar 1 week , 2 weeks, 3 weeks, 4 weeks
Method of measurement
Colony count
Intervention groups
1
Description
Intervention group : In Group A, the orthodontic wires 0.018 stainless steel coated with 100 nm titanium oxide layer are randomly located in the upper or lower jaw and after one week exit from mouth.
Category
Prevention
2
Description
Intervention group: In Group B, the orthodontic wires 0.018 stainless steel coated with 100 nm titanium oxide layer are randomly located in the upper or lower jaw and after two weeks exit from mouth.
Category
Prevention
3
Description
Intervention group: In group C, the orthodontic wires 0.018 stainless steel coated with 100 nm titanium oxide layer are randomly placed in the upper or lower jaw and exit after three weeks from mouth.
Category
Prevention
4
Description
Intervention group: In Group D, the orthodontic wires 0.018 stainless steel coated with 100 nm titanium oxide layer are randomly placed in the upper or lower jaw and exit after four weeks from mouth.
Category
Prevention
5
Description
Control group: The control group is uncoated orthodontic wires 0.018 stainless steel that is placed in the opposite jaw in front of the intervention group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan dental school
Full name of responsible person
Vahid Mollabashi
Street address
Shahid Fahmideh Ave., Hamadan University of Medical Science
City
Hamadan
Province
Hamadan
Postal code
65178-38677
Phone
+98 81 3838 1059
Email
zbanisafar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Hamedan University of Medical Science
Full name of responsible person
Dr Saeed Bashirian
Street address
Shahid Fahmideh Ave., Hamadan University of Medical science
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1059
Email
zbanisafar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Ziba Banisafar
Position
post graduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmideh Ave.,Hamadan University of Medical Science
City
Hamadan
Province
Hamadan
Postal code
65178-38677
Phone
+98 81 3838 1059
Email
zbanisafar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ziba Banisafar
Position
postgraduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmideh Ave., Hamadan University of Medical Science
City
Hamadan
Province
Hamadan
Postal code
65178-38677
Phone
+98 81 3838 1059
Email
zbanisafar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ziba Banisafar
Position
Postgraduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmideh Ave., Hamadan University of Medical Science
City
Hamadan
Province
Hamadan
Postal code
65178-38677
Phone
+98 81 3838 1059
Email
zbanisafar@yahoo.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 including demographic characteristics and original outcome information are shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutes and dental material industry
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
Ziba Banisafar, Corresponding author, zbanisafar@yahoo.com
Vahid Mollabashi, First authorو mollabashi@umsha.ac.ir
What processes are involved for a request to access data/document
After 6 month of result publication through electronic E-Mail of corresponding author and complete introduction and mention the goal from having the documentation, related file is available to the applicant.