Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant (Part 2)

NCT04793256 | Unknown

• 1 other identifier: 115
• Study Type: interventional
• Target: 91
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cost Effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cost-effectiveness (will be measured with Incremental cost effective ratio ICER

  through study completion, an average of one year

Other Outcomes (3)

• Time of application (continuous outcome, (minutes) will be measured with stopwatch.

  Through application of interventions in treatment visit( baseline)

• acceptability will be measured by questionnaire

  through study completion, an average of one year

• adverse effect will be measured by questionnaire

  through study completion, an average of one year

Study Arms (2)

intervention

EXPERIMENTAL

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

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

comparator

ACTIVE COMPARATOR

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

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

Interventions

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

5% sodium fluoride Varnish is a fluoride varnish which is applied to tooth surfaces

Also known as: 5% sodium fluoride varnish 3M

intervention

Resin based fissure sealant (3M Clinpro Sealant) DEVICE

teeth will be isolated with cotton rolls and saliva ejector than etching for pits and fissure sealant

Also known as: Resin based fissure sealant 3M

comparator

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

samah Ahmed, B.sc

CONTACT

00201112000386; samah.ahmed@dentistry.cu.edu.eg

Passant Nagi, phd

CONTACT

0201280557107; passant.Nagi@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No one is blinded ( unfortunately) as fissure sealant will be obvious
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 11, 2021
• Study Start: April 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 11, 2021

Record last verified: 2021-03