Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant

Cost Effectiveness Clinical Trial

Official title:

Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Fissure Sealant in Newly Erupted Permanent Molars in Group of Egyptian Children : A Randomized Clinical Trial ( Part 1)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04603573
• Other study ID #: 112
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2021
• Est. completion date: September 2022

Study information

• Verified date: January 2021
• Source: Cairo University
• Contact: Esraa Mohamed Zaghloul, B.Sc
• Phone: 0201146030022
• Email: Esraa.Mohamed[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is determine the cost-effectiveness, clinical-effectiveness, acceptability and adverse effect of resin sealants versus the fluoride varnish for the prevention of dental caries on newly erupted permanent molars.

Description:

A Cochrane systematic reviews found low quality evidence supporting Current practice guidelines that recommend the use of Resin based fissure sealant over Fluoride varnish in prevent dental caries. However, they did not address the cost-effectiveness, A more recent systematic review and meta-analysis concluded that no statistical significance difference between Resin based fissure sealant and Fluoride varnish with a high-quality evidence in prevent dental caries.

This trial will measure cost effectiveness and clinical effectiveness for resin fissure sealant and fluoride varnish.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 91
• Est. completion date: September 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Healthy children with no physical or mental disorders. Children with newly fully erupted permanent molars (PMs).

Exclusion Criteria:

• Teeth will be excluded from the study if they had any of the following:

• Dental caries in dentine

• History of pain or swelling. Parents refused their children participate in the trial

Related Conditions & MeSH terms

• Cost Effectiveness

Intervention

Device:
• fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride )
5% Sodium Fluoride Varnish is a fluoride varnish which is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth. The varnish is applied in a thin layer over the tooth with an applicator brush, and moisture from saliva cures the varnish for adhesion to the tooth surface.
• Resin based fissure sealant (3M Clinpro sealant )
teeth will be isolated with coton rolls and saliva ejector then etching for pits and fissure then tooth will be washed then apply resin based fissure sealant on occlusal surface. resin fissure sealant is a more sensitive for saliva.

Locations

Country	Name	City	State
Egypt	Oral and dental medicine Cairo university	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical-effectiveness (will be measured with DFS	Clinical-effectiveness (will be measured by DFS) Clinical effectiveness (continuous outcome will be measured with DFS D Decayed in permanent molar Filling in permanent molar S Surface	Through study completion, an average of one year
Secondary	Cost-effectiveness (will be measured with Incremental cost effective ratio ICER	Cost-effectiveness (will be measured with Cost-effectiveness will be calculated based on the following measures:-; Economic measures (continuous outcome, (money) will be measured with Calculate The total cost of each of FV and FS in every visit) .; Clinical effectiveness (continuous outcome will be measured with DFS.	through study completion, an average of one year
Secondary	Time of application (continuous outcome, (minutes) will be measured with stopwatch.	Time of application (continuous outcome, (minutes) will be measured with stopwatch.	Through application of interventions in treatment visit( baseline)
Secondary	acceptability will be measured by questionnaire	I will ask the parent and child if this trial is acceptable or not	through study completion, an average of one year
Secondary	adverse effect will be measured by questionnaire	Questionnaire for the parent (allergy, diarrhea or vomiting )	through study completion, an average of one year