Back to resultsClinical Evaluation of Efficacy of Shield Force Plus Varnish VS Sodium Fluoride on Dentin Hypersensitivity
Primary Purpose
Dentin Hypersensitivity, Dentin Desensitizing Agents
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TOKUYAMA SHIELD FORCE PLUS
Sodium Fluoride 5% Dental Varnish
Sponsored by
About this trial
This is an interventional treatment trial for Dentin Hypersensitivity focused on measuring Dentin hypersensitivity, Dentin sensitivity, Shield force plus, Dentin Desensitizing Agents, sodium fluoride varnish
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Shield Force Plus Varnish
Sodium Fluoride varnish
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Dentin Hypersensitivity
measurement of dentin hypersensitivity by VAS Scale
Dentin Hypersensitivity
measurement of dentin hypersensitivity by VAS Scale
Dentin Hypersensitivity
measurement of dentin hypersensitivity by VAS Scale
Dentin Hypersensitivity
measurement of dentin hypersensitivity by VAS Scale
Dentin Hypersensitivity
measurement of dentin hypersensitivity by VAS Scale
Secondary Outcome Measures
Dentinal Tubule Occlusion
percentage of dentinal tubule occlusion measure by scanning electron microscope SEM
Dentinal Tubule Occlusion
percentage of dentinal tubule occlusion measure by scanning electron microscope SEM
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04484844
Brief Title
Clinical Evaluation of Efficacy of Shield Force Plus Varnish VS Sodium Fluoride on Dentin Hypersensitivity
Official Title
Clinical Evaluation of Efficacy of Shield Force Plus Varnish Versus Sodium Fluoride on Cervical Dentin Hypersensitivity on Adult Patients: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity, Dentin Desensitizing Agents
Keywords
Dentin hypersensitivity, Dentin sensitivity, Shield force plus, Dentin Desensitizing Agents, sodium fluoride varnish
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Shield Force Plus Varnish
Arm Type
Experimental
Arm Description
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.
Arm Title
Sodium Fluoride varnish
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TOKUYAMA SHIELD FORCE PLUS
Intervention Description
Self-reinforcing (SR) monomer technology
Intervention Type
Drug
Intervention Name(s)
Sodium Fluoride 5% Dental Varnish
Intervention Description
5% NaF
Primary Outcome Measure Information:
Title
Dentin Hypersensitivity
Description
measurement of dentin hypersensitivity by VAS Scale
Time Frame
Pre-intervention
Title
Dentin Hypersensitivity
Description
measurement of dentin hypersensitivity by VAS Scale
Time Frame
2 min
Title
Dentin Hypersensitivity
Description
measurement of dentin hypersensitivity by VAS Scale
Time Frame
1 week
Title
Dentin Hypersensitivity
Description
measurement of dentin hypersensitivity by VAS Scale
Time Frame
4 weeks
Title
Dentin Hypersensitivity
Description
measurement of dentin hypersensitivity by VAS Scale
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Dentinal Tubule Occlusion
Description
percentage of dentinal tubule occlusion measure by scanning electron microscope SEM
Time Frame
Pre-intervention
Title
Dentinal Tubule Occlusion
Description
percentage of dentinal tubule occlusion measure by scanning electron microscope SEM
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feras Mustafa Salem, BSc
Phone
00201008471183
Email
feras.fares@dentistry.cu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Efficacy of Shield Force Plus Varnish VS Sodium Fluoride on Dentin Hypersensitivity
We'll reach out to this number within 24 hrs