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

NCT04485299 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: OPR 20/7/2020
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Dentinal tubule occlusion

  Pre-intervention

• Dentinal tubule occlusion

  8 weeks

Study Arms (2)

bifluorid 10 varnish

EXPERIMENTAL

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

sodium fluoride varnish

ACTIVE COMPARATOR

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

Interventions

Bifluorid 10 ,VOCO DRUG

NaF and CaF 10 %

Also known as: Bifluorid 10

bifluorid 10 varnish

Sodium Fluoride 5% Dental Varnish DRUG

5% NaF

Also known as: conventional sodium fluoride varnish

sodium fluoride varnish

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Hypersensitivity; Dentin Sensitivity

Interventions

Sodium Fluoride

Condition Hierarchy (Ancestors)

Immune System Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Zaid Yousef Alkhatteb, BSc

CONTACT

00201272111897; zaid_yousef@denstistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree student - faculty of dentistry

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 24, 2020
• Study Start: October 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: July 24, 2020

Record last verified: 2020-07