Protocol summary

Summary
Dental caries is the most common chronic human disease. One of the best ways to prevent occlusal caries is fissure sealant therapy. The ability of fissure sealant to prevent fissure caries is related to sealant retention. Considering the fact that several bonding agents are available in market, clinical evaluations are required to find the durability of the sealants after using bonding agents. The purpose of this study was to compare the durability of the fissure sealant after applying dentin and enamel bonding agents. Thirty healthy 6 to 12 year-old patient with at least one caries-free, fully erupted molar in both sides of mandible were selected. Patients randomly divided into two groups. All fissures of 60 molars were sealed. Group1: Acid etch, dentin bonding Single Bond (3M, ESPE) and Echosealsealant (VERICOM).Group2: Acid etch, enamel bonding Margin Bond (Coltene/Whaledent AG) and Echoseal sealant. Clinician and patients did not know what kind of bonding agents were used. Cotton roll isolation was used for both groups. Sealants were evaluated 12 months after placement.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014020816525N1
Registration date: 2014-03-22, 1393/01/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-03-22, 1393/01/02
Registrant information
Name
Hamid Moradian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1730 1134
Email address
moradianh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-03-30, 1390/01/10
Expected recruitment end date
2012-06-30, 1391/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical success rate of fissure sealant with enamel and dentin bonding agents
Public title
Comparison of clinical success rate of fissure sealant with enamel and dentin bonding agents
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 6 to 12 year old patient; at least one caries-free, fully erupted molar in both sides of mandible
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: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Namazi square, Zand street, Shiraz
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
5589

Health conditions studied

1

Description of health condition studied
Relationship between retention of fissure sealant and dentin and enamel bonding agents
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Retention of fissure sealant
Timepoint
12 month
Method of measurement
Clinical examination

Secondary outcomes

empty

Intervention groups

1

Description
In first group we used acid etch, dentin bonding Single Bond and Echoseal sealant.
Category
Prevention

2

Description
In second group we used acid etch, enamel bonding Margin Bond and Echoseal sealant.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mr. Eskandari
Street address
Namazi square, Zand street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Asiye Zohrei
Position
Post graduate student of pediatric dentistry
Other areas of specialty/work
Street address
Pediatric department, dentistry faculty, Ghasre Dasht street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1730 1134
Fax
Email
asiye.zohrei@yahoo.com moradianh@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Asiye Zohrei
Position
Post graduate student of pediatric dentistry
Other areas of specialty/work
Street address
Pediatric department, dentistry faculty, Ghasre Dasht street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1730 1134
Fax
Email
asiye.zohrei@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Asiye Zohrei
Position
Post graduate student of pediatric dentistry
Other areas of specialty/work
Street address
Pediatric department, dentistry faculty, Ghasre Dasht street, Shiraz
City
Shiraz
Postal code
12345
Phone
+98 71 1730 1134
Fax
Email
asiye.zohrei@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...