Clinical Evaluation of Efficacy of Shield Force Plus Varnish VS Sodium Fluoride on Dentin Hypersensitivity

NCT ID: NCT04484844

Last Updated: 2020-07-24

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

PHASE2/PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-31

Study Completion Date

2021-01-31

Brief Summary

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The aim of the study to compare the clinical effectiveness of Shield Force Plus (SFP) versus sodium fluoride varnish in the management of hypersensitivity of cervical dentin in adult patients for 8weeks.

Detailed Description

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Conditions

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Dentin Hypersensitivity Dentin Desensitizing Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Shield Force Plus Varnish

Shield force plus (SFP), Self-reinforcing (SR) monomer technology supplied in the form of one component self-etching light-cured dental adhesive, which is characterized by an SR monomer component that penetrates the tooth substrate. Multi-point interactions with apatite calcium and three-dimensional cross-linking occur reactions.it forms a thin even, hard coating on the tooth surface that gives the tooth substrate a superior binding power.

Group Type EXPERIMENTAL

TOKUYAMA SHIELD FORCE PLUS

Intervention Type DRUG

Self-reinforcing (SR) monomer technology

Sodium Fluoride varnish

Topical application of varnish fluoride (sodium fluoride NaF) effect on exposed dentine as a desensitizing agent, the varnish fluoride process is caused by the reaction between NaF and calcium ions resulting in calcium fluoride crystals being deposited on the openings of the dentinal tubules that decrease pain.

Group Type ACTIVE_COMPARATOR

Sodium Fluoride 5% Dental Varnish

Intervention Type DRUG

5% NaF

Interventions

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TOKUYAMA SHIELD FORCE PLUS

Self-reinforcing (SR) monomer technology

Intervention Type DRUG

Sodium Fluoride 5% Dental Varnish

5% NaF

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with good oral hygiene.
* The age range of 18-65 years.
* Patients from both gender.
* Patients suffering from pain due to dentin hypersensitivity.
* Patients with sound first upper molars.

Exclusion Criteria

* Patients with teeth exhibiting mobility (grade 2 or 3).
* Patients with constant use of analgesic, carious lesions, fractured teeth, defective restorations or prosthesis.
* Patients with orthodontics appliance.
* Patients with allergy sufferers with any of the materials will be used in the study as shield force plus and sodium fluoride.
* Patients with carious, crowned upper first molars.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Feras Mustafa Fares Salem

Master's degree student - faculty of dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Feras Mustafa Salem, BSc

Role: CONTACT

00201008471183

Other Identifiers

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OPER 20/7/2020

Identifier Type: -

Identifier Source: org_study_id

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