Determining the failure rate of bonded brackets with two bonding systems, LightCure and Nomix
Design
A double-blind, randomized clinical trial on 23 patients.
Settings and conduct
This study is a double-blind clinical trial to compare the rate of band failure with two bonding systems Nomix and Light Cure during 12 months in patients referred to a private treatment center. The method of blinding in this study is that except for the therapist and patients, the student participating in the research and the person statistically analyzing the results, will not know the bonding system used in the right and left premolars of the maxillary quadrants. Brackets are bonded with self-cure and light-cure bondings for selected patients as split-mouth in the maxillary premolars. With once a month follow-up, by observing the brackets, the failure rate of the bracket bond will be checked and according to the checklist, the time of the bond failure and the tooth with a bond failure will be recorded by the therapist.
Participants/Inclusion and exclusion criteria
Patients in need of fixed orthodontic treatment with inclusion criteria for no occlusal interference in the posterior region; no caries no presence of congenital anomalies of the facial surface of maxillary premolars. Exclusion criteria: patients with occlusal interference with brackets; the facial surface of maxillary premolars with restoration and fluorosis; caries and the history of bracket bonding
Intervention groups
Fixed orthodontic treatment with split-mouth design by brackets bonded with two groups of light cure and nomix bondings for maxillary premolars for each patient.
Main outcome variables
Bonding system and failure rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210906052389N2
Registration date:2021-10-24, 1400/08/02
Registration timing:prospective
Last update:2021-10-24, 1400/08/02
Update count:0
Registration date
2021-10-24, 1400/08/02
Registrant information
Name
Maziar Esmailimoghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3336 3590
Email address
esmailimoghaddam.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2022-10-12, 1401/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Failure Rates of Orthodontic Brackets Bonded by no-mix and Light Cure Bonding Systems : A Randomized Clinical Trial
Public title
Failure Rates of Orthodontic Brackets Bonded by no-mix and Light Cure Bonding Systems : A Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with malocclusion who need fixed orthodontic treatment
Patients without age and sex restrictions
No occlusal interference in the posterior region
No caries and congenital anomalies of the facial surface of maxillary premolars
Exclusion criteria:
Patients with occlusal interactions with brackets
Facial surface of maxillary premolars with restoration and fluorosis, caries and previous bracket bond
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
23
More than 1 sample in each individual
Number of samples in each individual:
2
Premolars in the maxilla bonded with brackets by different bonding systems
Randomization (investigator's opinion)
Randomized
Randomization description
The bonding material for the upper premolar brackets bond on the left and right is selected randomly, so that in the first patient, for example, the upper left premolar bracket is bonded with a light cure and the upper right premolar is bonded with a self-cure and do this method vice versa in the next patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of blinding in this study is that except for the therapist and patients, the student participating in the research and the person statistically analyzing the results, they wont know the bonding system used in the right and left premolars of the maxillary quadrants
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Resalat Street, above the Modiriat Street next to the emergency, Urmia Medical Sciences Headquarters
City
Orumieh
Province
West Azarbaijan
Postal code
5714783734
Approval date
2021-08-25, 1400/06/03
Ethics committee reference number
IR.UMSU.REC.1400.191
Health conditions studied
1
Description of health condition studied
Dental crowding and maxilofacial dentoskeletal abnormalities
ICD-10 code
M26
ICD-10 code description
Dentofacial anomalies [including malocclusion]
Primary outcomes
1
Description
Bracket bond failure
Timepoint
Determining bond failure by observing from the beginning to the end of the study with one-month follow ups
Method of measurement
Number of bonding failure rate of bracket per unit time
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fixed orthodontic treatment with split-mouth design by brackets bonded with two groups of light cure and Nomix bondings, both with Master-Dent brand, made in the USA on maxillary premolars in each patient, whose teeth are first cleaned with rubber cup and pumice paste and washed and dried with water. After rinsing, the facial surface of the teeth for bracket attachment is etched with 37% phosphoric acid for 20 seconds and then the etched site is washed for 40 seconds (15) and then the bonding procedures are performed according to the instructions of the bonding material manufacturer for the premolars on both sides of the maxilla. Patients are evaluated for 12 months with one-month follow-up periods for bracket bond failure on either side.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthodontic private office of Dr.Maziar Esmailimoghaddam
Full name of responsible person
Maziar Esmaili Moghaddam
Street address
Khanbabakhan St. Andisheh Building 2
City
Orumieh
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3225 4777
Email
maziaremoghaddam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Alborz st
City
Orumieh
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3336 3590
Email
mohebbi_iraj@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iraj Mohebbi
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
Oroumia University of Medical Sciences
Full name of responsible person
Hatef Mohammadi
Position
Dentistry student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Uorjans Alley, Resalat Boulevard
City
Orumieh
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3336 3590
Email
hatefm7677@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Maziar Esmaili Moghadam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Uorjans Alley, Resalat Boulevard
City
Orumieh
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3336 3590
Email
maziaremoghaddam@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hatef Mohammadi
Position
Dentistry student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Uorjans Alley, Resalat Boulevard
City
Orumieh
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3336 3590
Email
hatefm7677@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All data is potentially shareable after unidentifiyng individuals
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no condition.
From where data/document is obtainable
By email or phone number
What processes are involved for a request to access data/document
After requesting to receive the data, the data will be available to the person one week later.