Protocol summary

Summary
Purpose: the effects of two adhesives on the success rate of fissure sealant in the contaminated enamel. inclusion criteria: existing two sound maxillary permanent molar tooth or at least one tooth with remembered characteristics - moderate oral hygiene - no existing systemic disease exclusion criteria: uncooperative patient. In this study; 35 school children (6-8 years of age from Isfahan Jay area)with healthy and newly-erupted upper jaw molar teeth were participated, 60 molar teeth were selected(in the spring 1385) and divided into two groups. For one group, PQ1 and for the other, PROMPT-L-POP was used. As the teeth were newly erupted and the distopalatal area being in contact with the gingival sulcus and so it was impossible to isolate, the distal area was considered as contaminated and the mesial area capable of adequate isolation were assumed isolated. In each group, after etching, in one side, teeth were treated with sealant only and on the other side at first bonding agent was applied and then treated with sealant. So, two control groups were formed for each bonding agent. After 3, 6 and 12-month intervals, the results of the treatment were studied in terms of the success and failure rates.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903184123N1
Registration date: 2010-09-08, 1389/06/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-09-08, 1389/06/17
Registrant information
Name
Parvin Khadem
Name of organization / entity
Khoorasgan branch of Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 31 1261 5677
Email address
p.khadem@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2006-03-21, 1385/01/01
Expected recruitment end date
2006-04-21, 1385/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical assessment of using two types of adhesive (PQ1, Prompt-l-pop) on the success rate of fissure sealant with and without saliva contamination
Public title
Clinical assessment of using two types of adhesive (PQ1, Prompt-l-pop) on the success rate of fissure sealant with and without saliva contamination
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: existing two sound maxillary permanent molar tooth or at least one tooth with remembered characteristics - moderate oral hygiene - no existing systemic disease exclusion criteria:don't have cooperation of patient
Age
From 6 years old to 8 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
khorasgan branch Islamic Azad University
Street address
Argavanieh, Islamic Azad University
City
Isfahan
Postal code
81595-158
Approval date
empty
Ethics committee reference number
23810201862008

Health conditions studied

1

Description of health condition studied
the effect of using bonding on fissure sealant success rate
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Success rate of fissure sealant
Timepoint
3, 6, and 12 month
Method of measurement
Position of fissure sealant (intact, partially failed, completly failed)

Secondary outcomes

1

Description
Decay
Timepoint
3, 6, 12 months
Method of measurement
Oral examination

2

Description
Discoloration
Timepoint
3, 6, 12 months
Method of measurement
Oral examination

Intervention groups

1

Description
intervention 2: use of pq1 bonding; no dose
Category
Treatment - Drugs

2

Description
intervention 1:use of prompt l pop bonding; no dose
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Community dentistry center of Islamic Azad University
Full name of responsible person
Parvin Khadem
Street address
unit 3, Navid building, Navid allay, Shariati street
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khorasgan branch Islamic Azad University
Full name of responsible person
Parvin Khadem
Street address
unit 3, Navid building, Navid allay, Shariati street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khorasgan branch Islamic Azad University
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
Khorasgan branch of Islamic Azad University
Full name of responsible person
Parvin Khadem
Position
MS, DDS, Assistant Professor of Community Dentistry
Other areas of specialty/work
Street address
Community Dentistry Group
City
Isfahan
Postal code
81595-158
Phone
+98 31 1261 5677
Fax
+98 31 1261 5691
Email
p.khadem@khuisf.ac.ir; parkhadem@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khorasgan branch o islamic azad university
Full name of responsible person
Parvin Khadem
Position
MS, DDS
Other areas of specialty/work
Street address
unit 3, Navid building, Navid allay, Shariati street
City
Isfahan
Postal code
81595-158
Phone
+98 31 1261 5677
Fax
+98 31 1261 5691
Email
p.khadem@khuisf.ac.ir; parkhadem@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Parvin Khadem
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
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
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