Evaluation of the Effect of different methods of fluoride agents prescription on the load-deflection characteristics of Rhodium-Coated NiTi orthodontic wires.
Design
A non-randomized, single-blind, control group, parallel group clinical trial
Settings and conduct
This study has been conducted on patients referred to Babol Dental School to evaluate the effect of fluoride anticaries agent on a type of orthodontic wire. To do so, the wires are placed in the mouth of the patients, and how to use fluoride is separately explained for each group. After 6 weeks, the wires will be evaluated using Atomic force microscopy. This double-blind study is blinded for both patients and statistical analyzer.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient who has the ability to maintain proper oral hygiene. A patient who has all the maxillary teeth.
Exclusion criteria: Patients who do not have the ability to maintain proper oral hygiene. Patients using certain mouthwashes. Patients who have a specific disease affecting the salivary flow (such as Sjogren, etc.). Patients using drugs that have an effect on the salivary flow. Patients who smoke or drink alcohol. Patients who have open-bite. Patients who have long face. Patients who have high levels of acidic food intake in their diet. Patients who have severe crowding in the flat part of the orthodontic wire.
Intervention groups
Control group: Patients who only use fluoride toothpaste.
Intervention group 1: Patients who use fluoride toothpaste with daily fluoridated mouthwash
Intervention group 2: Patients who use fluoride toothpaste with fluoride gel.
Main outcome variables
Arithmetic mean height (Sa); root mean square height (Sq); maximum height (Sz); root mean square gradient (Sdq); developed interfacial area ratio (Sdr)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180102038190N1
Registration date:2019-03-12, 1397/12/21
Registration timing:registered_while_recruiting
Last update:2019-03-12, 1397/12/21
Update count:0
Registration date
2019-03-12, 1397/12/21
Registrant information
Name
Sedigheh Sheikhzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3233 4389
Email address
s.sheikhzadeh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of different methods of fluoride agents prescription on the Surface roughness of Rhodium coated NiTi orthodontic wires
Public title
Effect of fluoride on orthodontic wire
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are able to afford adequate health care
Patients who have all of the maxillary teeth
Patients between 15-25 years old
Exclusion criteria:
Patients who are not able to afford adequate health care
Patients using certain mouthwashes
Patients who have a specific disease affecting the flow of saliva (such as ُSjogren's syndrome, etc.)
Patients who use a drug that has an effect on the flow of saliva
smokers and alcohol drinkers
patients who have dental openbite
patients who are longface.
patients who have high acid intake in their diet.
patients who have excessive crowding on the straight part of wire
Age
From 15 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
the data analyst does not know the type of substance received by the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganjafrooz Ave., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2017-02-05, 1395/11/17
Ethics committee reference number
MUBABOL.REC.1395.224
Health conditions studied
1
Description of health condition studied
Effect of fluoride on orthodontic wires
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
measured values on "Atomic force microscopy"
Timepoint
Evaluating wires by Atomic force microscopy at the beginning of the study (before intervention) and 6 weeks after placement in the mouth
Method of measurement
Evaluating surface by Atomic force microscopy
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Use of fluoride toothpaste (Oral-B 315 ppm) twice daily
Category
Diagnosis
2
Description
Intervention group: Use Oral-B fluoride toothpaste twice a day with 0.05% fluoride and use daily mouthwash (Oral-B 226 ppm)once a day (15 ml) after brushing for 30 seconds. eating and drinking for 30 minutes after use is prohibited.
Category
Diagnosis
3
Description
Intervention group: Use Oral-B fluoride toothpaste twice a day with 0.05% fluoride and use fluoride gel (Sultan1.23% Fluoride ion, pH = 3.5): The gel is placed in the mouth of the patient once for 60 seconds, according to the manufacturer's recommendation. eating and drinking for 30 minutes after use is prohibited.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol School of Dentistry
Full name of responsible person
Meisam Mirzaie
Street address
Entefazeh Square., Babol School of Dentistry
City
Babol
Province
Mazandaran
Postal code
47176-43633
Phone
+98 11 3229 1408
Email
s.sheikhzadeh@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Ganjafrooz Ave., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
s.sheikhzadeh@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Meisam Mirzaie
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
orthodontics
Street address
Entefazeh Squre., Babol School of Dentistry
City
Babol
Province
Mazandaran
Postal code
47176-43633
Phone
+98 11 3219 9592
Email
s.sheikhzadeh@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Meisam Mirzaie
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Entefazeh Squre., Babol School of Dentistry
City
Babol
Province
Mazandaran
Postal code
47176-43633
Phone
+98 11 3219 9592
Email
s.sheikhzadeh@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Meisam Mirzaie
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Entefazeh Squre., Babol School of Dentistry
City
Babol
Province
Mazandaran
Postal code
47176-43633
Phone
+98 11 3219 9592
Email
s.sheikhzadeh@mubabol.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available