1. Home
  2. Approved trials
  3. » فارسی

Clinical comparison of retention, caries and marginal integrity of a self etching fissure sealant to conventional sealant:12 months follow up

Protocol summary

Summary
Objective: The objective of this study is to compare a self-etching sealant with a conventional fissure sealant over 3, 6 and 12 months follow up. Study designing: double blinded randomized clinical trial Methods: in this clinical trial, sample group consisted of 200 first permanent molars teeth of 50 children aged 7 to 9 years. Selection criteria include four fully erupted first permanent molars in each patient and the permanent molars have deep, narrow and retentive fissures. The first permanent molars with occlusal or approximal caries and Patients with any bruxism or malocclusion are exclusion criteria. A split mouth technique, where the two techniques will be randomly allocated to either the right or the left side of the mouth is used. On the one side, a self-etching light cured fissure sealant, Prevent Seal (Itena, Paris, France) and on the other side, a conventional light-cured fissure sealant concise (3M ESPE,St.Paul,MN,USA) will be used. At the follow-up visits after 3 and 6months the sealants will be evaluated in terms of retention, the presence of caries and marginal integrity according to Modified USPHS system and two groups will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110157800N1
Registration date: 2011-12-17, 1390/09/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-12-17, 1390/09/26
Registrant information
Name
Morteza Saleki
Name of organization / entity
Islamic Azad University, Khorasgan branch
Country
Iran (Islamic Republic of)
Phone
+98 31 1535 4066
Email address
m.saleki@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Dental Research, School of Dentistry, Azad University, Khorasgan branch, Isfahan, Iran Dr. Morteza Saleki
Expected recruitment start date
2011-11-13, 1390/08/22
Expected recruitment end date
2011-11-17, 1390/08/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical comparison of retention, caries and marginal integrity of a self etching fissure sealant to conventional sealant:12 months follow up
Public title
effect of sealing teeth with self etching fissure sealant
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: a) four fully erupted first permanent molars in each patient b)first permanent molars with deep ,retentive and sound fissures c)without any caries in other teeth d)doing oral hygiene methods by the patients exclusion criteria: a)first permanent molars with occlusal or proximal caries b)Patients with any bruxism or malocclusion c)semi erupted first permanent molars
Age
From 7 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Azad University Khorasgan branch, Isfahan, Iran.
Street address
School of dentistry, Azad University Khorasgan branch, Arghavaniye Boulevard, khurasgan
City
Khurasgan
Postal code
Approval date
2011-07-02, 1390/04/11
Ethics committee reference number
23810201892036

Health conditions studied

1

Description of health condition studied
dental caries
ICD-10 code
K02.9
ICD-10 code description
Dental caries, unspecified

Primary outcomes

1

Description
fissure sealant retention
Timepoint
3 , 6 and 12 months
Method of measurement
Modified USPHS

2

Description
incipient caries
Timepoint
3, 6 and12 months
Method of measurement
Modified USPHS

3

Description
marginal integrity of fissure sealant
Timepoint
3 , 6and 12 months
Method of measurement
Modified USPHS

Secondary outcomes

1

Description
fissure sealant porosity
Timepoint
3 , 6 and12 months
Method of measurement
Modified USPHS

Intervention groups

1

Description
Intervention:Self etching fissure sealant, Prevent seal: after cleaning the tooth surface,fissure sealant is allocated without any etching and rinsing.
Category
Treatment - Other

2

Description
Control:conventional fissure sealant:3M:before sealant placement,doing etching and rinsing for 15 and 20 seconds,respectively.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farhangian Dental clinic
Full name of responsible person
Dr. Morteza Saleki, Post graduate student of pediatric dentistry
Street address
City
Shahreza

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Dental Research, School of Dentistry, Azad University, Khorasgan branch
Full name of responsible person
Dr. Vahid Esfahanian
Street address
School of Dentistry, Khorasgan Azad University, Arghavaniye Boulevard, Khorasgan, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Dental Research, School of Dentistry, Azad University, Khorasgan branch
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
School of Dentistry, Azad University, Khorasgan branch
Full name of responsible person
Dr. Morteza Saleki
Position
Post graduate Student of Pediatric Dentistry
Other areas of specialty/work
Street address
School of Dentistry, Khorasgan Azad University, Arghavaniye Boulevard, Khorasgan, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1535 4066
Fax
Email
m.saleki@khuisf.ac.ir
Web page address
www.khuisf.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Dentistry, Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Shahrzad Javadinejad
Position
Assistant professor, Department of Pediatric Dentistry, School of Dentistry, Azad University, Khoras
Other areas of specialty/work
Street address
Department of Pediatric Dentistry, School of Dentistry, Khorasgan Azad University, Arghavaniye Boulevard, Khorasgan, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1535 4066
Fax
Email
sharzad1618@yahoo.com
Web page address
www.khuisf.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic azad University, Khorasgan branch
Full name of responsible person
Dr. Morteza Saleki
Position
Postgraduate student of pediatric dentistry
Other areas of specialty/work
Street address
School of Dentistry, Khorasgan Azad University, Isfahan, iran
City
Isfahan
Postal code
Phone
+98 31 1535 4066
Fax
Email
mortezasaleki@gmail.comm.saleki@khuisf.ac.ir
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...