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

Primary Purpose

Hypersensitivity, Dentin Sensitivity

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bifluorid 10 ,VOCO
Sodium Fluoride 5% Dental Varnish
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypersensitivity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    bifluorid 10 varnish

    sodium fluoride varnish

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Dentin hypersensitivity
    measurement of dentin hypersensitivity by VAS scale
    Dentin hypersensitivity
    measurement of dentin hypersensitivity by VAS scale
    Dentin hypersensitivity
    measurement of dentin hypersensitivity by VAS scale
    Dentin hypersensitivity
    measurement of dentin hypersensitivity by VAS scale
    Dentin hypersensitivity
    measurement of dentin hypersensitivity by VAS scale

    Secondary Outcome Measures

    Dentinal tubule occlusion
    Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM
    Dentinal tubule occlusion
    Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM

    Full Information

    First Posted
    July 19, 2020
    Last Updated
    July 22, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04485299
    Brief Title
    Clinical Assessment of Bifluorid 10 vs Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient
    Official Title
    Quantitative Clinical Assessment of Bifluorid 10 Versus Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2020 (Anticipated)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    January 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypersensitivity, Dentin Sensitivity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    68 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    bifluorid 10 varnish
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    sodium fluoride varnish
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Bifluorid 10 ,VOCO
    Other Intervention Name(s)
    Bifluorid 10
    Intervention Description
    NaF and CaF 10 %
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium Fluoride 5% Dental Varnish
    Other Intervention Name(s)
    conventional sodium fluoride varnish
    Intervention Description
    5% NaF
    Primary Outcome Measure Information:
    Title
    Dentin hypersensitivity
    Description
    measurement of dentin hypersensitivity by VAS scale
    Time Frame
    pre-intervention
    Title
    Dentin hypersensitivity
    Description
    measurement of dentin hypersensitivity by VAS scale
    Time Frame
    2 min
    Title
    Dentin hypersensitivity
    Description
    measurement of dentin hypersensitivity by VAS scale
    Time Frame
    1 week
    Title
    Dentin hypersensitivity
    Description
    measurement of dentin hypersensitivity by VAS scale
    Time Frame
    4 weeks
    Title
    Dentin hypersensitivity
    Description
    measurement of dentin hypersensitivity by VAS scale
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Dentinal tubule occlusion
    Description
    Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM
    Time Frame
    Pre-intervention
    Title
    Dentinal tubule occlusion
    Description
    Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zaid Yousef Alkhatteb, BSc
    Phone
    00201272111897
    Email
    zaid_yousef@denstistry.cu.edu.eg

    12. IPD Sharing Statement

    Learn more about this trial

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

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