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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-10

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cost Effectiveness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be randomized, allocation-blinded, two-arm, parallel-group trial. The participants will be randomized on a 1: 1 allocation ratio to receive one of the following interventions:

* Resin-based fissure sealant FS.
* Fluoride varnish FV

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

No one is blinded ( unfortunately) as fissure sealant will be obvious

Study Groups

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(intervention)

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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.

comparator

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

Group Type ACTIVE_COMPARATOR

Resin based fissure sealant (3M Clinpro sealant )

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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5% Sodium Fluoride Varnish 3M resin fissure sealant 3M

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes