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NCT04484844 Clinical Trial

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

Dentin Hypersensitivity Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04484844
Other study ID # OPER 20/7/2020
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 2020
Est. completion date January 2021

Study information
Verified date July 2020
Source Cairo University
Contact Feras Mustafa Salem, BSc
Phone 00201008471183
Email feras.fares@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 68
Est. completion date January 2021
Est. primary completion date December 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• TOKUYAMA SHIELD FORCE PLUS
Self-reinforcing (SR) monomer technology
• Sodium Fluoride 5% Dental Varnish
5% NaF

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Outcome
Type Measure Description Time frame Safety issue
Primary Dentin Hypersensitivity measurement of dentin hypersensitivity by VAS Scale Pre-intervention
Primary Dentin Hypersensitivity measurement of dentin hypersensitivity by VAS Scale 2 min
Primary Dentin Hypersensitivity measurement of dentin hypersensitivity by VAS Scale 1 week
Primary Dentin Hypersensitivity measurement of dentin hypersensitivity by VAS Scale 4 weeks
Primary Dentin Hypersensitivity measurement of dentin hypersensitivity by VAS Scale 8 weeks
Secondary Dentinal Tubule Occlusion percentage of dentinal tubule occlusion measure by scanning electron microscope SEM Pre-intervention
Secondary Dentinal Tubule Occlusion percentage of dentinal tubule occlusion measure by scanning electron microscope SEM 8 weeks
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