Effect of home and office bleaching methods on the shear bond strength of metal brackets
Design
A clinical trial with 3 parallel groups with different interventions, single-blind, randomized, phase 2 is performed on 175 randomized teeth using Random allocation software.
Settings and conduct
Among the patients referred to the specialized department of Tabriz Dental School who need extraction of premolars in the orthodontic treatment process, participate in the study. Patients are randomly divided into three groups. In the home bleaching group, 20% carbamide peroxide will be used for three hours a day for 8 days, and in the office bleaching group, 45% hydrogen peroxide will be used for three days and half an hour a day. After bleaching, both intervention groups are divided into 3 subgroups (n = 25). In the first subgroup 24 hours, in the second 1 week, and in the third 15 days after bleaching the brackets are bonded to the tooth surface and after 30 days the teeth are extracted. The shear bond strength will be measured. In control, no bleaching process will be performed. The evaluator is not aware of the type and timing of teeth bleaching.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients whose mesiodistal width of the premolars is similar and approximately 7-8 mm
Exclusion criteria: Has congenital anomalies and structural defects in the premolars
Intervention groups
Group A: They are treated in the office before bleaching the brackets
Group B: Before bonding the brackets are treated at home bleaching
Control group: Do not undergo bleaching before bonding brackets
Main outcome variables
ُShear bond strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220519054918N1
Registration date:2022-05-23, 1401/03/02
Registration timing:registered_while_recruiting
Last update:2022-05-23, 1401/03/02
Update count:0
Registration date
2022-05-23, 1401/03/02
Registrant information
Name
Sattar Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 974 0206
Email address
akbarisattar2@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-23, 1401/03/02
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of home and office bleaching methods on the shear bond strength of metal brackets
Public title
Investigation of the effect of home and office bleaching on the strength of orthodontic metal brackets
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Orthodontic patients whose treatment plan includes premolar extraction
Patients in the age group of 15-35 years
Patients without hypoplasia or severe wear on premolar teeth
Patients without restoration or caries in premolar teeth
Patients who have not previously used chemicals such as hydrogen peroxide for bleaching or other treatments
Exclusion criteria:
Patients with congenital anomalies and structural defects in premolars
Patients with dental allergies
Age
From 15 years old to 35 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
175
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is simple and its unit is individual. Randomization tools include the use of random number tables with random allocation. Participants are randomly assigned to one of the groups. Assignment of treatment to patients will also be done randomly. In this way, the type of treatment with the code A (bleaching in the clinic), B (home bleaching), and C (control) is specified and the patient will be given the treatment using a random number table with random allocation. None of the patients is informed of the other patient's treatment.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding in the shear bond strength assessment stage should be done for the person measuring the bond strength, which will be done by coding the studied groups. Recognize from evaluation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2022-05-11, 1401/02/21
Ethics committee reference number
IR.TBZMED.REC.1401.157
Health conditions studied
1
Description of health condition studied
Dental anomalies
ICD-10 code
Z46.4
ICD-10 code description
Encounter for fitting and adjustment of orthodontic device
Primary outcomes
1
Description
Shear bond strength
Timepoint
30 days after bleaching
Method of measurement
Materials testing machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In group A patients, the bleaching process will be performed in the office with carbamide peroxide (Opalescence Quick PF 45% kit, Ultradent, USA). In this way, 45% hydrogen peroxide will be placed on the teeth for three days and half an hour a day according to the factory instructions.
Category
Treatment - Other
2
Description
Intervention group: In group B patients, the bleaching process will be performed at home with carbamide peroxide (Opalescence PF 20%, Ultradent, USA). Thus, 20% carbamide peroxide will be placed on the teeth 8 hours a day for 8 days.
Category
Treatment - Other
3
Description
Control group: Control group: In patients in the control group, no bleaching process will be performed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Dental School
Full name of responsible person
Behnam Mirza Kouchaki
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
akbarisattar2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Kachuei
Street address
Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
akbarisattar2@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Sattar Akbari
Position
Orthodontic Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
akbarisattar2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sattar Akbari
Position
Orthodontic Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
akbarisattar2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sattar Akbari
Position
Orthodontic Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
akbarisattar2@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
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