In vivo comparison between the effect of GC composite without primer and conventional composite on white spot lesion around orthodontic brackets : A randomized clinical trial
impact assessment of GC without primer composite on white spot lesion around orthodontic brackets
Design
Randomized clinical trial with parallel control group, double blind, randomized according to file number sequence , at 9 mounts with 2 recalls
Settings and conduct
research occur in tehran azad dental university and 2 private office in tehran.
A split-mouth clinical trial study was performed on the lateral and premolar teeth of 50 patients. After etching and drying the Control quadrant we applied primer on the etched surface then we applied Transbond XT composite and brackets. In the opposite quadrant (case group) we did not apply primer after etching and drying and then we applied GC composite without primer with brackets on the tooth surface. After 6 and 9 months of treatment, we evaluated the caries with 2 dental student without knowing about bonding formation for assessment of WSL with ICDAS II index
Participants/Inclusion and exclusion criteria
all patient that visited at azad dental university and two private office in tehran in 1397
1. similar crowding of lateral and first pre molar
2. 3mm or more distance between brackets and gingiva
4. lateral and first pre molar without wsl , caries , retoration , crown
5. without smoking
6. no systemic disease and drugs that occur xerostomia
Intervention groups
one quadrant of maxilla and mandible that bond with gc without primer composite were case group and the other quadrant that bond with transbond xt composite were control groups.
Main outcome variables
WSL occur
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181027041476N1
Registration date:2019-10-06, 1398/07/14
Registration timing:retrospective
Last update:2019-10-06, 1398/07/14
Update count:0
Registration date
2019-10-06, 1398/07/14
Registrant information
Name
Elmira Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2204 2304
Email address
e_asadi@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-14, 1397/07/22
Expected recruitment end date
2018-11-13, 1397/08/22
Actual recruitment start date
2018-10-14, 1397/07/22
Actual recruitment end date
2018-11-13, 1397/08/22
Trial completion date
2019-08-13, 1398/05/22
Scientific title
In vivo comparison between the effect of GC composite without primer and conventional composite on white spot lesion around orthodontic brackets : A randomized clinical trial
Public title
In vivo comparison between the effect of GC composite without primer and conventional composite on white spot lesion around orthodontic brackets : A randomized clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
similar crowding in lateral and first pre molar in each arch
3 mm or more distance between brackets and gingiva
without history of fixed orthodontic treatment
no wsl, caries, crowns and restoration in lateral and first pre molar
Exclusion criteria:
smoking
without systemic disease and drugs that occur xerostomia
history of fixed orthodontic treatment
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
8
in each patient one quadrant in maxilla and the opposite site quadrant of mandible are bond with gc without primer composite and the other side of mandible and maxilla are bond with Transbond XT composite.
Actual sample size reached:
50
More than 1 sample in each individual
Actual sample size in each individual:
8
in each patient one quadrant in maxilla and the opposite site quadrant of mandible are bond with gc without primer composite and the other side of mandible and maxilla are bond with Transbond XT composite.
Randomization (investigator's opinion)
Randomized
Randomization description
selection of patients is based on sequence number of files. Odd numbers were given to right side of maxilla and left side of mandible and even numbers were given to left side of maxilla and right side of mandible were case group
Blinding (investigator's opinion)
Double blinded
Blinding description
bonding info and groups record by dentist but patient and 2 dental student assessor dont know this information.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran Azad University of Medical Sciences
Street address
NO 9 , neiestan 9 , pasdaran
City
tehran
Province
Tehran
Postal code
1946853314
Approval date
2018-10-13, 1397/07/21
Ethics committee reference number
IR.IAU.DENTAL.REC.1397.013
Health conditions studied
1
Description of health condition studied
Caries , White spot lesion
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
white spot lesion
Timepoint
6 and 9 months after bonding
Method of measurement
with ICDAS 2 Criteria , use ball end explorer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: first clean buccal surface with pumice powder and prophylactic cap to remove plaques. then etch buccal surface with phosphoric acid 37% (Reliance , Itasca , lll) for 20 seconds and then rinse it with water and dry it up to rise a chalky white appearance. Then According to the manufacturer's brochure, we dont put primer and only put GC without primer composite (GC Ortho Connect 90-1100-000) with bracket on the dental surface with light pressure and remove the extras with a scaler, then cure for 20 seconds (10s mesial and 10s distal).
Category
Prevention
2
Description
Control group: first clean buccal surface with pumice powder and prophylactic cap to remove plaques. then etch buccal surface with phosphoric acid 37% (Reliance , Itasca , lll) for 20 seconds and then rinse it with water and dry it up to rise a chalky white appearance. Then we put primer and cure for 20 seconds and then put Transbond XT composite with bracket on the dental surface with light pressure and remove the extras with a scaler, then cure for 20 seconds (10s mesial and 10s distal).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Azad University Dental branch
Full name of responsible person
Elmira Asadi
Street address
No 9 , Neiestan 9 , Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
elmiraasadi@yahoo.com
Web page address
http://dental.iautmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No 9 , Neiestan 9 , Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
drarashazizi@yahoo.com
Web page address
http://dental.iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Elmira Asadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 9, Neiestan 9 , Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2204 2304
Email
elmiraasadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elmira Asadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 9, Neiestan 9 , Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2204 2304
Email
elmiraasadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elmira Asadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 9, Neiestan 9 , Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2204 2304
Email
elmiraasadi@yahoo.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