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

July 22, 2020 updated by: Feras Mustafa Fares Salem, Cairo University

Clinical Evaluation of Efficacy of Shield Force Plus Varnish Versus Sodium Fluoride on Cervical Dentin Hypersensitivity on Adult Patients: A Randomized Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: TOKUYAMA SHIELD FORCE PLUS
Self-reinforcing (SR) monomer technology
Active Comparator: 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.
Drug: Sodium Fluoride 5% Dental Varnish
5% NaF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dentin Hypersensitivity
Time Frame: Pre-intervention
measurement of dentin hypersensitivity by VAS Scale
Pre-intervention
Dentin Hypersensitivity
Time Frame: 2 min
measurement of dentin hypersensitivity by VAS Scale
2 min
Dentin Hypersensitivity
Time Frame: 1 week
measurement of dentin hypersensitivity by VAS Scale
1 week
Dentin Hypersensitivity
Time Frame: 4 weeks
measurement of dentin hypersensitivity by VAS Scale
4 weeks
Dentin Hypersensitivity
Time Frame: 8 weeks
measurement of dentin hypersensitivity by VAS Scale
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dentinal Tubule Occlusion
Time Frame: Pre-intervention
percentage of dentinal tubule occlusion measure by scanning electron microscope SEM
Pre-intervention
Dentinal Tubule Occlusion
Time Frame: 8 weeks
percentage of dentinal tubule occlusion measure by scanning electron microscope SEM
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 24, 2020

Study Record Updates

Last Update Posted (Actual)

July 24, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPER 20/7/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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