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

NCT ID: NCT04485299

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2021-01-31

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

Conditions

Hypersensitivity; Dentin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bifluorid 10 ,VOCO

Intervention Type: DRUG

NaF and CaF 10 %

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.

Group Type: ACTIVE_COMPARATOR

Sodium Fluoride 5% Dental Varnish

Intervention Type: DRUG

5% NaF

Interventions

Bifluorid 10 ,VOCO

NaF and CaF 10 %

Intervention Type: DRUG

Sodium Fluoride 5% Dental Varnish

5% NaF

Intervention Type: DRUG

Other Intervention Names

Bifluorid 10; conventional sodium fluoride varnish

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Zaid Yousef Fakhry Al khateeb

Master's degree student - faculty of dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zaid Yousef Alkhatteb, BSc

Role: CONTACT

zaid_yousef@denstistry.cu.edu.eg

00201272111897

Other Identifiers

OPR 20/7/2020

Identifier Type: -

Identifier Source: org_study_id