Comparison of clinical success of the application of a universal adhesive in etch-and-rinse and etch-and-dry in fissure sealant of first permanent molar
(1) Objectives
Comparison of the clinical success of the use of a universal adhesive system in two method: etch-and-rinse and etch-and-dry and
(2) Design
Double blind split mouth randomized controlled clinical trial study
(3) Setting and conduct
After obtaining written consent from the parents of the selected children, the fissure sealant of the first permanent molars of the participants is done by applying a universal adhesive system in two different method.
(4) Participants including major eligibility criteria
6 to 12 years old children with intact first permanent molars
(5) Intervention
Two method of applying adhesive:1- etch-and-rinse technique, 2-etch-and-dry technique
(6) main outcome measures (primary and secondary outcome variables)
In the 6-month and one-year follow up, fissure sealants are evaluated in terms of discoloration, caries, and retention by a blind examiner.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100930228N1
Registration date:2017-09-19, 1396/06/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-19, 1396/06/28
Registrant information
Name
marzie boskabady
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3879 2564
Email address
boskabadymr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Mashhad University of Medical Sciences
Expected recruitment start date
2016-10-01, 1395/07/10
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical success of the application of a universal adhesive in etch-and-rinse and etch-and-dry in fissure sealant of first permanent molar
Public title
The effect of etching and not etching in clinical success of fissure sealants with a universal adhesive
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: having two healthy first permanent molar; healthy 6 to 12 years old children
Exclusion criteria: known allergy to the used resin materials; detectable dental caries in selected teeth; previous sealant or restoration; bruxism or malocclusion; Reluctance of patient to return for follow up and re-evaluation
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:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
mashhad university of medical sciences
Street address
mashhad-vakilabad blv- opposite of mellat park- dental school
City
mashhad
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.mums.sd.REC.1394.164
Health conditions studied
1
Description of health condition studied
prevention of dental caries in pit and fissures of permanent first molar
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
retention
Timepoint
6 month and 1 year after sealant therapy
Method of measurement
full retention, partial loss, total loss
Secondary outcomes
1
Description
dental caries using ICDAS2 visual classification
Timepoint
6 month and 1 year after sealant therapy
Method of measurement
score 0: intact surface near sealant margins, score 2: first evidences of demineralization after drying the surface, score 3: obvious visual color changes
Intervention groups
1
Description
intervention group 1: etch-and-rinse technique and then apply universal adhesive
Category
Prevention
2
Description
control group: apply universal adhesive without primary etch
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
mashhad dental school- pediatric dentistry department
Full name of responsible person
dr marzie boskabady
Street address
City
mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
mashhad university of medical sciensces
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
daneshgah street- ghoreishi building
City
mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
mashhad university of medical sciensces
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
mashhad university of medical sciences
Full name of responsible person
marzie boskabady
Position
assistant professor
Other areas of specialty/work
Street address
vakil abad boulevard-opposite of mellat park
City
mashhad
Postal code
Phone
+98 51 3806 7224
Fax
+98 38829500
Email
boskabadymr@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Assistant Professor of Pediatric Dentistry, Dental Materials Research Center, School of Dentistry, M
Full name of responsible person
marzie boskabady
Position
pediatric dentistry
Other areas of specialty/work
Street address
vakil abad boulevard- opposite of mellat park- mashhad dental school
City
mashhad
Postal code
Phone
+98 51 3806 7224
Fax
Email
boskabadymr@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)