The objective of this study was clinical comparison of the retention of preventive resin restoration using Nano-bonding and Etch-&-Rinse Adhesive systems ( Conventional method )
Design
In this study, 42 patients in the age group of 6-12 years were randomly selected by rand list software who had permanent molars with occlusal surfaces decay at the 2- sided mandibular molar and qualied for I-type preventive resin restoration . Then , patients were non-randomly divided in two control and control and intervention groups . Clinical-trial phase is not exemplified in this study .
Settings and conduct
This clinical trial study on prevention of decay progress will be done in Tabriz Dentistry Faculty . the samples will be 42 individuals in the age group of 6-12 years . In each sample , a tooth will be treated by preparation method with Nano-bonding and the same tooth in the opposite side will be treated with the conventional method ( etching acid and bonding) .
Participants/Inclusion and exclusion criteria
The criteria for entering the study are: group of 6-12 years of age - presence of permanent teeth of the first molar in the lower jaw on both sides, with minor decay at the occlusal level - evidence of oral hygiene at home - patient collaboration and acceptance of treatment - no therapeutic treatment has been performed on the teeth previously – possibility of isolation by cotton roll and suction. Exit criteria: history of medical illness that may interfere with treatment, drug affecting the saliva and its quality, history of allergy to any of the restorative materials – un cooperation of patient .
Intervention groups
Intervention group : preventive resin restoration therapy with Nano-bonding in a molar tooth in one quadrant of the mandible
control group : preventive resin restoration therapy with conventional method (Etch-&-Rinse Adhesive systems )
Main outcome variables
Retention of preventive resin restoration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100125003168N4
Registration date:2017-12-18, 1396/09/27
Registration timing:registered_while_recruiting
Last update:2017-12-18, 1396/09/27
Update count:0
Registration date
2017-12-18, 1396/09/27
Registrant information
Name
Leila Erfanparast
Name of organization / entity
Tabriz University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
erfanparastl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice-Chancellor, Tabriz University of Medical Sciences
Expected recruitment start date
2017-12-11, 1396/09/20
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Clinical comparison of preventive resin restoration retention using Nano-bonding and Etch-&-Rinse Adhesive systems (Conventional method)
Public title
The clinical comparison of two methods for pereventive resin restoration of young permanent teeth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
group of 6-12 years of age
presence of permanent teeth of the first molar in the lower jaw on both sides with minor decay at the occlusal level
evidence of oral hygiene at home
patient collaboration and acceptance of treatment
no therapeutic treatment has been performed on the teeth previously
possibility of isolation by cotton roll and suction
Exclusion criteria:
history of medical illness that may interfere with treatment
drug affecting the saliva and its quality
history of allergy to any of the restorative materials
uncooperation patient
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
More than 1 sample in each individual
Number of samples in each individual:
2
two first molar teeth with partial carious lesions at the occlusal level were in the lower jaw
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research vice-chancellor,Tabriz University of Medical Sciences
Street address
Daneshgah Ave. - Golgasht St.-Tabriz University of Medical Sciences
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2017-10-29, 1396/08/07
Ethics committee reference number
IR.TBZMED.REC.1396.642
Health conditions studied
1
Description of health condition studied
dental caries
ICD-10 code
k02.0
ICD-10 code description
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Primary outcomes
1
Description
The retention of restoration
Timepoint
3 and 6 months
Method of measurement
exploration and observation
Secondary outcomes
1
Description
The working time
Timepoint
3 and 6 months
Method of measurement
exploration and observation
Intervention groups
1
Description
intervention group : 1)tooth cleaning2)remove caries3)isolation4)using Nano-bonding (G-premi Bond,GC Corpration,Tokyo,Japan) and cure for 20 seconds5)use of sealant (Clinpro-3M,USA) and cure for 20 seconds6)evaluation of occlusion and do finish and polish
Category
Prevention
2
Description
Control group: 1)tooth cleaning2)remove caries3)isolation4)using 37% acid etch (Etch Rite , PULPDENT Corporation , USA)for 20 seconds then , Rinse acid for 20 seconds 5)use of bonding ( single bond 2, 3M ESPE, PULPDENT Corporation ,U.S.A) and cure for 15 seconds 6)use of sealant (Clinpro-3M,USA) and cure for 20 seconds7) evaluation of occlusion and do finish and polish
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Faculty of Dentistry-Department of Pediatric Dentistry
Full name of responsible person
leila Erfanparast
Street address
Daneshgah Ave- Golgasht St.-Tabriz Univdrsity of Medical Sciences-Faculty of Dentistry-Department of Pediatric Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
Erfanparastl@tbzmed.ac.ir
Web page address
http://dentistryfac.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Reasearch Vice-Chancellor- Tabriz University of Medical Sciences
Full name of responsible person
mohammad samiei
Street address
Daneshgah Ave- Golgasht St.- Main Buliding-3rd floor
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 4333 0310
Fax
+98 41 3334 6977
Email
Erfanparastl@tbzmed.ac.ir
Web page address
http://dentistryfac.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reasearch Vice-Chancellor- 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
faculty of dentistry
Full name of responsible person
leila Erfanparast
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshgah Ave-Golgasht St.- Faculty of Dentistry-Department of Pediatric Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 5965
Fax
+98 41 1334 6977
Email
Erfanparastl@tbzmed.ac.ir
Web page address
http://dentistryfac.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
faculty of dentistry
Full name of responsible person
Leila Erfanparast
Position
Associate professore
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshgah Ave-Golgasht St-Tabriz University of Medical Sciences-Faculty of Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 5965
Fax
+98 41 1334 6977
Email
Eranparastl@tbzmed.ac.ir
Web page address
http://dentistryfac.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Dentistry
Full name of responsible person
leila Erfanparast
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshgah Ave-Golgasht St-Tabriz University of Medical Sciences-Faculty of Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 5965
Fax
+98 41 1334 6977
Email
Erfanparastl@tbzmed.ac.ir
Web page address
http://dentistryfac.tbzmed.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