Comparison of salivary fluoride level following school_based fluoride varnish program and professional fluoride varnish therapy in dental office among 6-12 years old children
Comparison of salivary fluoride level following school_based fluoride varnish program and professional fluoride varnish therapy in dental office among 6-12 years old children
Design
Clinical trial, Randomized, Single blinded, Sample size : 24(pilot), Number of people in each group : 12
Settings and conduct
Saliva will be collected by dental student before and 30 minute after fluoride varnish application in schools and in dental clinic( by pediatric dentistry specialist) and salivary fluoride concentration will be analyzed with ion selective electrode of fluoride Data will be analyzed using analysis of covariance ANCOVA at a p < 0.05 level of significance.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. 6-12 years old children 2. People with good oral hygiene (who brush their teeth twice daily)
Exclusion criteria: 1. People with salivary flow rate lesser than 0.25 _1 ml/min 2. People with kidney disorders 3. Lack of cooperation for fluoride therapy or saliva collection 4. People who are resident in the area with lesser than 0.2 ppm fluoride in drinking water.
Intervention groups
1. Salivary sample will be collected before and 30 minutes after fluoride therapy which is done in schools.
2. Salivary sample will be collected before and 30 minutes after fluoride therapy which is done by pediatric dentist in dental office.
Main outcome variables
Salivary fluoride level
General information
Reason for update
Acronym
_
IRCT registration information
IRCT registration number:IRCT20200411047018N2
Registration date:2020-11-19, 1399/08/29
Registration timing:prospective
Last update:2020-11-19, 1399/08/29
Update count:0
Registration date
2020-11-19, 1399/08/29
Registrant information
Name
Azin Sohrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3332 2938
Email address
azin.sohrabi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of salivary fluoride level following school_based fluoride varnish program and professional fluoride varnish therapy in dental office among 6-12 years old children
Public title
Comparison of salivary fluoride level following school_based fluoride varnish program and professional fluoride varnish therapy in dental office among 6- 12 years old children
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
6-12 years old children
People who have good oral hygiene and brush their teeth twice daily with fluoride containing dentifrices
Exclusion criteria:
People with salivary flow rate lesser than 0.25 _1 ml/min
Children with kidney disorders
Lack of cooperation for fluoride therapy or collection of saliva
People who are resident in the area with lesser then 0.2 ppm fluoride in drinking water
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced (permuted) Block Randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyzer does not know the type of consumable and consumable is marked with codes
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tabriz university of medical sciences
Street address
Tabriz university of medical sciences, Golghasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
_
Approval date
2020-10-12, 1399/07/21
Ethics committee reference number
IR.TBZMED.RES 1399.701
Health conditions studied
1
Description of health condition studied
Dental caries
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Salivary fluoride concentration
Timepoint
Before the intervention and 30 minutes after intervention
Method of measurement
Ion selective electrode of fluoride
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The subject will get school based fluoride varnish therapy
Category
Prevention
2
Description
Intervention group:The subject will get professional fluoride therapy by pediatric dentistry specialist in dental clinic
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental faculity of tabriz university of madical sciences