evaluation the effect of titanium oxide coating of mandibular fixed retainer wire on reducing the adhesion of streptococcus mutans and lactobacillus bacteria compared to uncoated mandibular fixed retainer wires in orthodontic patients: a randomized clinical trial study
evaluation of fixed lingual orthodontic retainer wire coated with titanuim oxide on streptococcus mutans and lactobacillus adhesion in lower jaw in orthodontic patient
Design
Clinical trial with a single-blind, randomized phase 0 control group on 32 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 patient in need of fixed mandibular retainer after completion of treatment will be randomly selected as control and another patient will be randomly selected as intervention and retainer wires coated with titanium dioxide nanoparticles will be placed on teeth of the intervention group. The banding therapist and the participants are unaware of the intervention and control groups
Participants/Inclusion and exclusion criteria
inclusion criteria: Patients who are in the stage of orthodontic debonding and only need a fixed retainer in the lower jaw, do not use antibiotics and antibacterial mouthwashes during treatment, do not have a history of systemic diseases, and do not smoke.
exclusion criteria: presence of missing teeth, presence of craniofacial syndromes and anomalies
Intervention groups
patients who need fixed mandibular retainer wires after completion of orthodontic treatment are randomly bonded with 0.175 inch twisted orthotechnology brand wires coated with titanium dioxide. In the control group, they are randomly bonded with 0.175 inch twisted orthotechnology brand wires (without nanoparticles)
Main outcome variables
Adhesion rate of streptococcus mutans and lactobacillus bacteria to coated and uncoated retainer wires in the lower jaw
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140215016582N8
Registration date:2024-11-25, 1403/09/05
Registration timing:prospective
Last update:2024-11-25, 1403/09/05
Update count:0
Registration date
2024-11-25, 1403/09/05
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
2024-12-19, 1403/09/29
Expected recruitment end date
2025-02-17, 1403/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation the effect of titanium oxide coating of mandibular fixed retainer wire on reducing the adhesion of streptococcus mutans and lactobacillus bacteria compared to uncoated mandibular fixed retainer wires in orthodontic patients: a randomized clinical trial study
Public title
The effect of titanium oxide coating of mandibular fixed retainer wire on bacterial adhesion in orthodontic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are in the debonding stage of orthodontics and only need a fixed retainer in the lower jaw
Not using antibiotics and antibacterial mouthwashes during treatment
No history of systemic diseases
Not a smoker
Exclusion criteria:
The presence of missing teeth
The presence of craniofacial syndromes and anomalies
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method will be used and randomization unit will be individual. 16 cards are written as a and 16 as b and placed in the envelope, the participants are asked to choose a card randomly from the box. Code a indicates the normal mandibular fixed retainer wire and code b indicates the retainer wires coated with titanium dioxide. Only the first researcher will be aware of the codes
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants, the therapists who bind the retainer wires, the researcher who measures the bacterial count, and the analyzing researcher are unaware of the group assignment.
Placebo
Not used
Assignment
Parallel
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
Hamedan
Province
Hamadan
Postal code
6517838695
Approval date
2024-11-10, 1403/08/20
Ethics committee reference number
IR.UMSHA.REC.1403.582
Health conditions studied
1
Description of health condition studied
Adhesion of bacteria to fixed mandibular orthodontic retainer wires
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Adhesion of Streptococcus mutans and Lactobacillus bacteria to fixed mandibular retainer wires of orthodontic patients
Timepoint
6 months after the intervention
Method of measurement
After the sixth month, the retainer wire between the canine teeth and the mandibular first premolar in both groups as control and control groups was taken out of the patient's mouth and transferred to the microbiology laboratory of the medical school to count the number of bacteria. Wires are stored in a sterile container containing phosphate buffer.Then, in order to separate the bacteria from the wires, 25% trypsin and ethylenediamine-theta-acetate solution are added to the samples and placed at the laboratory temperature for 45 minutes to separate the bacteria from the surface of the wire. In the next step, different dilutions are prepared from the resulting suspension and then inoculated in a plate containing MSA agar to detect and isolate Streptococcus mutans and incubated at 37 degrees Celsius for 24 hours.The samples are also inoculated on MRS culture medium (lactobacilli selective medium) and incubated at 37°C for 48 hours. Routine microbiological tests including gram staining, oxidase test, catalase activity, carbohydrate fermentation, and bile salt tolerance test will be used to determine Lactobacillus strains. Then the bacteria are counted and reported as CFU/mL
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: dental bond from the lower right first premolar to the lower left first premolar with 0.175 inch retainer wires coated by titanium dioxide nanoparticles by vapor deposition method. After six months, the retainer wire between the canine teeth and the first premolar of the lower jaw is removed in the experimental group, and they are transferred to the microbiology laboratory of the Faculty of Medicine in order to count the number of bacteria
Category
Prevention
2
Description
Control group: Dental bond from lower right first premolar to lower left first premolar with 0.175" uncovered retainer wires. After six months, the retainer wire between the canine teeth and the mandibular first premolar in the control group is removed, and in order to count the number of bacteria, they are transferred to the microbiology laboratory of the Faculty of Medicine.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan university of medical sciences
Full name of responsible person
Hossein Sheikhi
Street address
Shahid Fahmideh
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3252 0182
Email
Hsheikhi1995@gmail.com
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
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1059
Email
Hsheikhi1995@gmail.com
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
Hossein sheikhi
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
Hsheikhi1995@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hossein sheikhi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmideh
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
0098 81 8216072
Email
Hsheikhi1995@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hossein Sheikhi
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
Hsheikhi1995@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
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.After result publication through electronic email 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