NCT04484844

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

July 20, 2020

Last Update Submit

July 22, 2020

Conditions

Dentin HypersensitivityDentin Desensitizing Agents

Keywords

Dentin hypersensitivityDentin sensitivityShield force plusDentin Desensitizing Agentssodium fluoride varnish

Outcome Measures

Primary Outcomes (5)

  • Dentin Hypersensitivity

    measurement of dentin hypersensitivity by VAS Scale

    Pre-intervention

  • Dentin Hypersensitivity

    measurement of dentin hypersensitivity by VAS Scale

    2 min

  • Dentin Hypersensitivity

    measurement of dentin hypersensitivity by VAS Scale

    1 week

  • Dentin Hypersensitivity

    measurement of dentin hypersensitivity by VAS Scale

    4 weeks

  • Dentin Hypersensitivity

    measurement of dentin hypersensitivity by VAS Scale

    8 weeks

Secondary Outcomes (2)

  • Dentinal Tubule Occlusion

    Pre-intervention

  • Dentinal Tubule Occlusion

    8 weeks

Study Arms (2)

Shield Force Plus Varnish

EXPERIMENTAL

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

Sodium Fluoride varnish

ACTIVE COMPARATOR

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

Interventions

TOKUYAMA SHIELD FORCE PLUSDRUG

Self-reinforcing (SR) monomer technology

Shield Force Plus Varnish
Sodium Fluoride 5% Dental VarnishDRUG

5% NaF

Sodium Fluoride varnish

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Tokuyama Shield Force PlusSodium Fluoride

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsSodium CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Central Study Contacts

Feras Mustafa Salem, BSc

CONTACT

00201008471183feras.fares@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's degree student - faculty of dentistry

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 24, 2020

Study Start

October 1, 2020

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

July 24, 2020

Record last verified: 2020-07