Comparison of bond failure rate of Orthodontic Brackets and Tubes bonded with Transbond XT or GC ortho connect adhesives, A six month randomized clinical trial
The aim of this 6-month randomized clinical trail was to compare the bond failure rate of orthodontic brackets and tubes bonded with GC ortho connect or Transbond XT adhesives.
Design
Randomized clinical trial with 2 intervention groups, Single blind, Randomization method by table of numbers, Including 100 patient
Settings and conduct
This study is done in Clinic of Bojnurd city school of dentistry. One hundred patients (50 maxillary and 50 mandibular arches) are evaluated. Overall, 1095 teeth are bonded (547 with GC ortho connect and 548 with Transbond XT). Patients are followed for 6 months and any attachment bond failures are registered. This study is single blind.
Participants/Inclusion and exclusion criteria
patients who need fixed orthodontic treatment
class I, II, III malocclusions
no buccal or labial restorations
Extraction or non extraction orthodontic treatment plans
Intervention groups
In intervention groups, GC ortho connect adhesive is used on one side of dental arch and on other side Transbond XT adhesive is used.
Main outcome variables
Orthodontic bond failure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191221045838N1
Registration date:2020-04-25, 1399/02/06
Registration timing:retrospective
Last update:2020-04-25, 1399/02/06
Update count:0
Registration date
2020-04-25, 1399/02/06
Registrant information
Name
mina moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 6787
Email address
m.moradi@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-03-17, 1398/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of bond failure rate of Orthodontic Brackets and Tubes bonded with Transbond XT or GC ortho connect adhesives, A six month randomized clinical trial
Public title
Bond failure rate of Orthodontic Brackets and Tubes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
patients who need fixed orthodontic treatment
class I, II, III malocclusions
no buccal or labial restorations
Extraction or non extraction orthodontic treatment plans
Exclusion criteria:
Teeth with facial restorations or congenital enamel defects
Semi erupted teeth
Second and third molars
Surgically exposed teeth
Occlusal interference
Patients who need orthognathic surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
2 intervention groups (group A&B), for example in A group Transbond XT is used on one side of dental arch and Gc ortho connect is used on the other side and in B group the opposite is done. Deployment in each group is done by simple randomization method and using table of numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
At first we inform the patient that 2 substances are to be used for treatment then we treat the patient without knowing which side of dental arch each substance is on.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of North Khorasan University of Medical Sciences
Street address
Shahryar street
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Approval date
2019-10-23, 1398/08/01
Ethics committee reference number
IR.NKUMS.REC.1398.072
Health conditions studied
1
Description of health condition studied
Orthodontic treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Orthodontic bond failure
Timepoint
6 months
Method of measurement
Check list
Secondary outcomes
empty
Intervention groups
1
Description
first Intervention group: Transbond XT adhesive from 3M unitek, U.S.A company. Randomly, attachments on one side of each jaw are bonded using this adhesive. The bond will be followed for 6 monthes and any failure is recorded.
Category
Treatment - Devices
2
Description
second Intervention group: GC Ortho Connect adhesive from GC Orthodontics, Japan company. On the other side of the jaw, attachments are bonded using this adhesive.The bond will be followed for 6 monthes and any failure is recorded. The bond will be followed for 6 monthes and any failure is recorded.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of bojnourd school of dentistry
Full name of responsible person
Mina Moradi
Street address
School of dentistry, Arkan road.
City
Bojnourd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3151 3322
Email
nkums.ac.ir@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Kaveh Hojjat
Street address
Deputy of research and technology, Nursing school, Shahryar st.
City
Bojnourd
Province
North Khorasan
Postal code
7487794149
Phone
+98 58 3229 6769
Email
research@nkums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Mina Moradi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahryar street
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3229 6787
Fax
Email
m.moradi@nkums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mina Moradi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahryar street
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3229 6787
Fax
Email
m.moradi@nkums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mina Moradi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahryar street
City
Bojnurd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3229 6787
Fax
Email
m.moradi@nkums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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