1. To examine oral health related quality of life among 8-10 year old schoolchildren in the Wasit Governorate- Iraq.
2. To assess the efficacy and the cost of preventive regimens used in both intensified and basic intervention groups.
Design
Controlled randomized Clinical trial with parallel groups, phase 2 on 372 participants, single center
Settings and conduct
Children from two schools (one boy school and one girl school randomly selected) will be allocated into basic intervention group and the children from other two schools (one boy and one girl ) will be allocated into intensified intervention group . Parents of children in clinical trial phase of this study will receive letter in which the study design will explain and they will ask to give their informed consent. Follow-up examinations of caries increment, extent of carious lesion using ICDAS index according to Braga etal (2009) (16) at 3, 6 months for children in both groups.
Children will be asked in each follow up about if they wash their mouth after each eating.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. schoolchildren aged 8-10 years old
2. cooperative children
3. children with consent parent
Exclusion criteria
1. children with systemic diseases
2. uncooperative children
3. Disabled children
4. Hereditary developmental defect of teeth .
5. Known allergy /sensitivity to any of dental material that will be used
Intervention groups
Basic intervention (control group) will consist of :
1. Oral health education. 2. Incentive package
Intensified intervention:
1. F-varnish will be applied every 3 months on the all tooth surfaces.
2. 38% silver diamine fluoride.
Main outcome variables
1. Caries progression,
2. Caries increment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220627055297N1
Registration date:2022-07-23, 1401/05/01
Registration timing:prospective
Last update:2022-07-23, 1401/05/01
Update count:0
Registration date
2022-07-23, 1401/05/01
Registrant information
Name
Hanan Alautry
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2242 1813
Email address
hananfadhil@uowasit.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-01, 1401/07/09
Expected recruitment end date
2023-05-15, 1402/02/25
Actual recruitment start date
2022-10-01, 1401/07/09
Actual recruitment end date
2023-05-15, 1402/02/25
Trial completion date
2023-05-15, 1402/02/25
Scientific title
Oral health related quality of life and comparison between preventive regimens among Iraqi preadolescents
Public title
Oral health related quality of life and comparison between preventive regimens among Iraqi preadolescents
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Schoolchildren aged 8-10 years old
Cooperative children
Children with consent parent
Exclusion criteria:
Children with systemic diseases (blood disease, CVD, diabetes mellitus, asthmatic children)
Uncooperative children
Disabled children
Hereditary developmental defect of teeth such as amelogensis imperfecta and dentinogensis imperfecta.
Known allergy /sensitivity to any of dental material that will be used
Age
From 8 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
372
Actual sample size reached:
372
Randomization (investigator's opinion)
Not 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
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Daneshjoo Blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2022-05-24, 1401/03/03
Ethics committee reference number
IR.SBMU.DRC.REC.1401.030
Health conditions studied
1
Description of health condition studied
Oral health condition, Dental caries
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Caries progression
Timepoint
Before intervention, 3, and 6 months after intervention
Method of measurement
International caries Detection and Assessment System (ICDAS) according to Braga et al. (2009) will be used in clinical trial phase . D 0 - Sound D1 - First visual change in enamel (white spot opacity first visible change only after air drying: white, brown). D2 - Distinct visual change in enamel (white spot opacity distinct visible change without air- drying: white, brown). D3 -Localized enamel breakdown due to caries with no visible dentin (localized enamel breakdown surface integrity loss) D4-Non-cavitated surface with underlying dark shadow from dentin (underlying dark shadow +/- surface integrity loss) D5 - Distinct cavity with visible dentin. D6 -Extensive distinct cavity with visible dentin.
Secondary outcomes
1
Description
Caries increment, and Cost – effectiveness of interventions
Timepoint
Before intervention, 3 and 6 months after intervention
Method of measurement
Decay surfaces (DS, dt ) according to WHO (2013). Criteria and codes of dental caries: 0 (A). Sound tooth 1 (B). Decayed tooth 2 (C). Filled tooth with decay .Dental caries indices: tooth (DT, dt) and surface levels (DS, ds) carious lesions were registered for all surfaces of each tooth included. The Decayed component (D) included all teeth with codes 1 or 2. Costs of preventive regimen will be examined from the perspective of a service provider:1. Direct medical cost ( materials and equipment, capital cost and time spent by service provider)2. Indirect cost (overhead cost)
Intervention groups
1
Description
Basic intervention group (control group) (standard self-care and oral hygiene practices such as brushing two times a day using fluoridated dentifrices, using dental floss, eating appropriate diet and regular dental visit by oral hygiene instruction, printed material distribution and incentive package providing ) and intensified intervention group (professional applications of preventive regimen without drilling procedures include fluoride varnishes and SDF as well as oral health education)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Primary schools
Full name of responsible person
Ahamed Shihab
Street address
GR58+G7V, Al-Hurh St., Kut, Iraq
City
Al-Kut
Postal code
197653987987
Phone
+964 773 364 0457
Fax
+964 773 364 0457
Email
hananfadhil@uowasit.edu.iq
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanan Al_autry
Street address
Department of Community Oral Health, Shahid Beheshti School of Dentistry, Daneshjoo Blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 1813
Fax
+98 21 2242 1813
Email
hananfadhil@uowasit.edu.iq
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hanan ِAlautry, Shahid Beheshti Uiversity of medical Sciences, School of Dentistry
Proportion provided by this source
100
Public or private sector
Private
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanan Alautry
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
Department of Community, Shahid Beheshti School of Dentistry, Daneshjoo Blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 1813
Fax
+98 21 2242 1813
Email
hananfadhil@uowasit.edu.iq
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanan Alautry
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
Department of Community, Shahid Beheshti School of Dentistry, Daneshjoo Blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 1813
Fax
+98 21 2242 1813
Email
hananfadhil@uowasit.edu.iq
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanan Alautry
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
Department of Community, Shahid Beheshti School of Dentistry, Daneshjoo Blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 1813
Fax
+98 21 2242 1813
Email
hananfadhil@uowasit.edu.iq
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available