Clinical retention comparison of fissure sealant versus flowable composite in type I adhesive conservative restorations after preparation with self etch bonding in children age 6-12
clinical retention comparison of fissure sealant versus flowable composite in type I adhesive conservative restorations after preparation with self etch bonding
Design
Clinical trial on 55 patients, 110 lower first molar teeth with parallel groups without blinding and randomization with coin toss
Settings and conduct
Selection of samples from the pediatric and community-oriented clients of Tabriz Dental School, obtaining informed consent from the patient's parents, determining caries by examination, tooth isolation and preparation of both sides and removing caries , using self-etch bonding on both sides and cure 10 s , apply the composite flow on one side and fissure sealant on the other side cure for 20-seconds at the end the occlusion will be checked ,comparison of retention after 3 and 6 months.
Participants/Inclusion and exclusion criteria
Entry conditions
1.Age group 6-12 years
2.Existence of first mandibular molar with caries limited to enamel on occlusal surface in both sides
3.Evidence of good oral hygiene at home
4.Patient cooperation and acceptance of treatment
5.No treatment has been done on the desired teeth before
6. The molar tooth is fully grown and can be isolated
7. No proximal caries
Exit conditions
1.History of a medical condition that may interfere with treatment
2.Mention the history of allergies to restorative materials
Intervention groups
The tooth is isolated and prepared on both sides. On both sides self-etching bonding material will be used and dried then curing will be done for 10 seconds. On one side the composite flow is applied and on the other side the sealant will be placed and curing will be done for 20 seconds .
Main outcome variables
1.determining retention of preventive restoration while using composite flow,
2.determining retention of preventive restoration while using fissure sealant,
3.retention comparison of composite flow and fissure sealant
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210609051529N1
Registration date:2021-07-27, 1400/05/05
Registration timing:registered_while_recruiting
Last update:2021-07-27, 1400/05/05
Update count:0
Registration date
2021-07-27, 1400/05/05
Registrant information
Name
Naiemeh Shahveghar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3476 3163
Email address
shahvegharnaiemeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical retention comparison of fissure sealant versus flowable composite in type I adhesive conservative restorations after preparation with self etch bonding in children age 6-12
Public title
Clinical retention comparison of fissure sealant versus flowable composite in type I adhesive conservative restorations
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age group 6-12 years
Existence of first mandibular molar with caries limited to enamel on occlusal surface on both sides
Evidence of good oral hygiene at home (regular brushing, flossing, regular fluoride therapy)
Patient cooperation and acceptance of treatment (according to Frankel classification in group 3 or 4)
No treatment has been done on the desired teeth before
The molar is fully grown and can be isolated
No proximal caries (evaluation by bite wing and clinical radiography)
Exclusion criteria:
History of a medical condition that may interfere with treatment
Consumption of drugs that affect saliva and its quality
Mention the history of allergies to any of the restorative materials
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
55
More than 1 sample in each individual
Number of samples in each individual:
2
2 mandibular first molar
Randomization (investigator's opinion)
Randomized
Randomization description
Assigning the type of restorative material to the right and left quadrants will be done randomly by dropping a coin, according to which flow composite is placed on the molar on one side and sealant on the other side.
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
Ethics committee of Tabriz University of Medical Sciences
Street address
17plaque , Sardrudi avenue,Shahriar st , Valiasr blvd , Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5157673879
Approval date
2021-05-22, 1400/03/01
Ethics committee reference number
IR.TBZMED.REC.1400.170
Health conditions studied
1
Description of health condition studied
permanent tooth caries
ICD-10 code
K02.51
ICD-10 code description
Dental caries on pit and fissure surface limited to enamel
Primary outcomes
1
Description
Clinical retention of conservative restoration due to modified simonsen's criteria
Timepoint
3 and 6 month after finishing treatment
Method of measurement
Modified Simonsen's criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first lower molar is isolated on one side and prepared with bur no 329 after removing caries two layer of self etch bonding is applied and cured for 10 seconds with light cure (400mw/cm2). The flow composite material (MASTER DENT, flow composite, USA) is then applied to the cavity and pit and fissures then cured again for 20 seconds. Finally, the occlusion is checked with articulator paper.
Category
Prevention
2
Description
Control group: The first lower molar is isolated on one side and prepared with bur no 329 after removing caries two layer of self etch bonding is applied and cured for 10 seconds with light cure (400mw/cm2). The fissure sealent (MASTERDENT,light cure pit and fissure sealent,U.S.A) is then applied to the cavity and pit and fissures then cured again for 20 seconds. Finally, the occlusion is checked with articulator paper.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric and community-based section of Tabriz dental university
Full name of responsible person
Leila Erfanparast
Street address
Tabriz dental school , Tabriz medicine university , Golgasht st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
dent.fac@tbzmed.ac.ir
Web page address
https://dentistryfac.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samii
Street address
Tabriz faculty of dentistry , Golgasht st ,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
dent.fac@tbzmed.ac.ir
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
70
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
Leila Erfanparast
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pediatric ward, Tabriz faculty of dentistry, Golgasht st., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
041 3335 5965
Phone
+98 41 3335 5965
Email
erfanparast.l@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Erfanparast
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pediatric ward, Tabriz faculty of dentistry, Golgasht st., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
erfanparast.l@tabzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Erfanparast
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pediatric wand, Tabriz faculty of dentistry, Golgasht st., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
0098904133355965
Email
erfanparast.l@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentifieing individuals
When the data will become available and for how long
6 months from the start of research and preparation of new results
To whom data/document is available
All researchers who are interested in this subject and want to do similar research
Under which criteria data/document could be used
It can be used to perform similar research with intended process
From where data/document is obtainable
To receive data, send an email to Dr. Erfanparast (Pediatric dentist of Tabriz Dental School) : erfanparast.l@tbzmed.ac.ir
What processes are involved for a request to access data/document
An applicant can access the study after the end of the study (about 6 months after the treatment) by sending an email to the study supervisor or by phone and explaining the reason for obtaining the data.