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

Phase 2

• Conditions: Hypersensitivity; Dentin Sensitivity
• Interventions: Drug: Bifluorid 10 ,VOCO; Drug: Sodium Fluoride 5% Dental Varnish

• Registration Number: NCT04485299
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-19
• Study First Submitted QC: 2020-07-22
• Last Update Submitted: 2020-07-22
• Study First Posted: 2020-07-24
• Last Update Posted: 2020-07-24
• Study Start: 2020-10
• Primary Completion: 2020-12
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bifluorid 10 varnish	Bifluorid 10 ,VOCO	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.
sodium fluoride varnish	Sodium Fluoride 5% Dental 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.

Primary Outcome Measures

Name	Time	Method
Dentin hypersensitivity	8 weeks	measurement of dentin hypersensitivity by VAS scale

Secondary Outcome Measures

Name	Time	Method
Dentinal tubule occlusion	8 weeks	Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM