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

Cairo University (CU)

Status: Unknown

Conditions: Cost Effectiveness

Treatments: Device: fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride ); Device: Resin based fissure sealant (3M Clinpro sealant )

Study type: Interventional

Funder types: Other

Identifiers

NCT04603573

112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

(intervention)

Experimental group

Description:

Fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride). Group (1)

Treatment:

Device: fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride )

comparator

Active Comparator group

Description:

Resin based fissure sealant (3M Clinpro Sealant, light cure, low viscosity, fluoride release).group (2)

Treatment:

Device: Resin based fissure sealant (3M Clinpro sealant )