The split-mouth design was employed. In this method, teeth of contrary two quadrants (36–46 and/or 16–26 teeth) were randomly allocated in either the intervention or the control groups. Sample size was 185 school children. The study population consisted of all primary school students (1st and 2nd grade) between the ages of 8 to 10-years-old from the low socio-economic rural areas of Golpayegan city of Isfahan province. The intervention was Fissure sealant treatment carried out by the senior dental students. It was provided as a part of "field program” of Department of Oral Public Health in 2015. Regarding the six codes of ICDAS dental caries, severity for all full-erupted first permanent molars was recorded at baseline. After selection the eligible teeth, the paired teeth were randomly allocated either to the intervention or to the control by previously designed cards After one year the treated teeth were evaluated. An assistant opened the unreadable cards by L as left and R as right signs. The primary outcome of the study was the occurrence of new caries (ICDAS code 3–6) at the 1-year follow-up. The secondary outcome was the sealant’s retention status which evaluated as complete retention, partially retention or fully lost after one year. evaluate the effectiveness of the community fissure sealant program by assessing the odds of new caries between the two sealant and control groups. The prevalence of different status of sealant retention is reported too.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082229476N1
Registration date:2017-02-20, 1395/12/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-20, 1395/12/02
Registrant information
Name
Bahareh Tahani
Name of organization / entity
Oral Public Health Department, Dental School, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5594
Email address
tahani@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellery of Research Affairs , Isfahan University of Medical Sciences
Expected recruitment start date
2015-04-22, 1394/02/02
Expected recruitment end date
2016-05-23, 1395/03/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of community based Fissure-Sealant therapy in decreasing the level of dental caries in 6-12 years old school children
Public title
effectiveness of Fissure-Sealant therapy in decreasing the level of dental caries in 6-12 years old school children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: all primary school students (1st and 2nd grade) between the ages of 8 to 10-years-old; low socio-economic rural areas of Golpayegan city of Isfahan province; permanent residents; having at least two sound teeth in two contrary quadrants; teeth with deep sound pit and fissures or primary dental caries (ICDAS 0-2)
Exclusion Criteria: no patient cooperation; parents not being eager to participate
Age
From 7 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
185
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
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hezarjarib ST, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
293220
Health conditions studied
1
Description of health condition studied
Dental Caries
ICD-10 code
K02.0–K02.
ICD-10 code description
Primary outcomes
1
Description
Sealant retention
Timepoint
exactly after treatment, one year after treatment
Method of measurement
Oral Examination
2
Description
Caries Incidence
Timepoint
before the treatment, One year after the treatment
Method of measurement
Oral Examination and ICDAS recording
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: The intervention was Fissure sealant treatment carried out by the senior dental students. It was provided as a part of "field program” of Department of Oral Public Health in 2015. Teeth of contrary two quadrants (36–46 and/or 16–26 teeth) were randomly allocated in either the intervention or the control groups. Teeth with deep pit and fissures either healthy or at early stages of enamel decay (ICDAS 0-2) were included in the study and regarding the six codes of ICDAS dental caries, severity for all full-erupted first permanent molars was recorded at baseline. The treatment process included cleaning teeth with low-speed tooth brushing without prophylaxis paste, isolation with cotton rolls and suction, etching with Ultra etch gel (35% phosphoric acid, ultradent Products Inc, USA) for 30 seconds. After thoroughly water rinsing and air drying, applying the bonding agent by Single Bond 2(3M ESPE, USA) and curing, resin-based sealant was applied (Prime-Dent®. Prime Dental manufacturing Inc.3735 W. Belmont Ave. Chicago) to the pit and fissures on the occlusal and buccal surfaces. Using curing light (device LED light cure Woodpecker Medical Instrument Co, China 400-600 mw/cm2) all coated surfaces exposed for 45 seconds. After setting the sealant, teeth were checked by supervisors for retention, air bubbles and occlusal adjustments. If necessary, the processes were repeated
Category
Prevention
2
Description
Control group: The teeth in the contrary quadrant received no treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Red cresent center
Full name of responsible person
Dr Alireza Farzanekhoo
Street address
City
Golpayegan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellery of Research Affairs
Full name of responsible person
Dr. Omid Savabi
Street address
Hezarjarib st, Isfahan University of Medical Sceinces
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery of Research Affairs
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
Oral Public Health Department, Dental School, Isfahan University of Medical Sciences
Full name of responsible person
Dr Imaneh Asgari
Position
PhD in Community oral Health
Other areas of specialty/work
Street address
Hezarjarib ST
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 5594
Fax
+98 31 1668 7080
Email
asgari_i@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oral Public Health Department, IsfahanUniversity of Medical Sciences
Full name of responsible person
Dr. Bahareh Tahani
Position
PhD in community dental health
Other areas of specialty/work
Street address
Hezarjarib st, Isfahan University of Medical Sciences
City
Iafahan
Postal code
8174673461
Phone
+98 31 3792 5594
Fax
Email
tahani@dnt.mui.ac.irtahani_b@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Oral Public Health Department, Dental School, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Bahareh Tahani
Position
Assistant Professor/ PhD of community oral health
Other areas of specialty/work
Street address
Isfahan, Hezrjarib ST
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 5594
Fax
Email
tahani@dnt.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)