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

Not Applicable

• Conditions: Cost Effectiveness
• Interventions: Device: Resin based fissure sealant (3M Clinpro sealant ); Device: fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride )

• Registration Number: NCT04603573
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-27
• Status Verified: 2021-01
• Study Start: 2021-07-10
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-08-02
• Primary Completion: 2022-08
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
comparator	Resin based fissure sealant (3M Clinpro sealant )	Resin based fissure sealant (3M Clinpro Sealant, light cure, low viscosity, fluoride release).group (2)
(intervention)	fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride )	Fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride). Group (1)

Primary Outcome Measures

Name	Time	Method
Clinical-effectiveness (will be measured with DFS	Through study completion, an average of one year	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

Secondary Outcome Measures

Name	Time	Method
adverse effect will be measured by questionnaire	through study completion, an average of one year	Questionnaire for the parent (allergy, diarrhea or vomiting )
Cost-effectiveness (will be measured with Incremental cost effective ratio ICER	through study completion, an average of one year	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.
acceptability will be measured by questionnaire	through study completion, an average of one year	I will ask the parent and child if this trial is acceptable or not
Time of application (continuous outcome, (minutes) will be measured with stopwatch.	Through application of interventions in treatment visit( baseline)	Time of application (continuous outcome, (minutes) will be measured with stopwatch.

Trial Locations

Locations (1)

Oral and dental medicine Cairo university; 🇪🇬 Giza, Egypt