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

Cairo University (CU)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Dentin Sensitivity; Hypersensitivity

Treatments: Drug: Bifluorid 10 ,VOCO; Drug: Sodium Fluoride 5% Dental Varnish

Study type: Interventional

Funder types: Other

Identifiers

NCT04485299

OPR 20/7/2020

Details and patient eligibility

About

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

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

bifluorid 10 varnish

Experimental group

Description:

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.

Treatment:

Drug: Bifluorid 10 ,VOCO

sodium fluoride varnish

Active Comparator group

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.

Treatment:

Drug: Sodium Fluoride 5% Dental Varnish