Clinical Assessment of Bifluorid 10 vs Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient

Quantitative Clinical Assessment of Bifluorid 10 Versus Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient: A Randomized Clinical Trial

Aim of the study will be conducted to compare the efficacy of bifluoride (NaF and CaF) versus conventional fluoride varnish (Sodium Flouride) in the management of hypersensitivity of exposed cervical area in adult patients over 2 month

Study Overview

• Status: Unknown
• Conditions: Hypersensitivity; Dentin Sensitivity
• Intervention / Treatment: Drug: Sodium Fluoride 5% Dental Varnish; Drug: Bifluorid 10 ,VOCO

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Phase 2; Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy patient with free medical history.
• Age range 18-60 years old.
• Good oral hygiene
• Patients suffering from pain due to dentin hypersensitivity.
• Patient with sound first molar .

Exclusion Criteria:

• Patients using desensitizing agents, receiving periodontal treatment or had received nonsurgical periodontal treatment in the last three months.
• Patient wearing orthodontic appliance.
• Patient with teeth having a painful condition involving the pulp and periapical region.
• Patients who had allergy to materials will be used in the study.
• Pregnancy.
• Patient who does not consent to participation.
• Patient who does not attend to the follow up.
• A patient who has a carious first molar.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bifluorid 10 varnish; Bifluorid 10 (NaF and CaF) lead to reduce the dentin hypersensitivity, the sodium fluoride (NaF) dissociates and releases F ions, that diffuse through the tubules and then precipitates as calcium fluoride as a consequence of the high of calcium content in saliva and dentinal fluid ,The calcium fluoride (CaF) present in the varnish composition diffuses into the tubules and block the canal with a semi-permanent protective layer.The calcium fluoride is added to block the dentin tubules mechanically, by the combination with the calcium fluoride resulted from the sodium fluoride reaction to the calcium of dentin.	Drug: Bifluorid 10 ,VOCO; NaF and CaF 10 %; Other Names: Bifluorid 10
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; Other Names: conventional sodium fluoride varnish

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

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 19, 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

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride; Fluorides, Topical
• Other Study ID Numbers: OPR 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