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Effect of Using Different Varnishes on Dentin Hypersensitivity; Na Fluoride and Nano-silver Fluoride

Primary Purpose

Dentin Hypersensitivity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Citrine 5 % sodium fluoride
concocted nano-silver fluoride
Sponsored by
Nayera Hassanien Mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients consulting in one of the Qasr Einy, faculty of dentistry outpatient clinics.
  • Males or females.
  • Patient's age range 25-50 years.
  • Patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bi-cuspids, and first molars with exposed cervical dentine) with teeth scoring Bpain (VAS score: greater than or equal to 3) during application of stimulus (airblast and tactile sensitivity test).
  • Tooth with exposed root surface, complaining from hypersensitivity (VAS score; greater than or equal to 3).
  • Patients accept the 2-months follow-up period.
  • Provide informed consent.

Exclusion Criteria:

  • • Patients participating in another dental study that may alter the results of this study.

    • A medical condition that could hinder the accuracy of pain reporting (e.g., pain disorders).
    • Any chronic medical condition that requires the regular use of anti-inflammatory pain medications.
    • Patients used or applied a desensitizing varnish within the last four weeks.
    • Patients with dental problems; chipped teeth, defective restorations, fractured Un-displaced cuspids or deep dental caries.
    • Lack of patient's approval and compliance.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Citrine 5% Sodium Fluoride

    concocuted Nano-silver fluoride

    Arm Description

    It was developed to prolong the contact between the tooth surface and fluoride to increase the resistance against caries attack and manage tooth hypersensitivity; the active ingredient of fluoride varnish is mostly 5% sodium fluoride.

    Nano-silver fluoride (NSF) is a laboratory synthesized solution

    Outcomes

    Primary Outcome Measures

    change in dentin Hypersensitivity
    Visual Analogue Scale (VAS) will be used; 0 is no pain and 10 is severe pain. Pictures are added to the same, as well as colors to guide the patient during selection of pain severity.

    Secondary Outcome Measures

    change in dentinal Tubule Occlusion
    the dentinal tubule occlusion of citrine 5% sodium fluoride and the dentinal tubule occlusion of nano-silver fluoride for treatment of dentin hypersensitivity and compare them together

    Full Information

    First Posted
    October 6, 2020
    Last Updated
    January 29, 2021
    Sponsor
    Nayera Hassanien Mohamed
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04731766
    Brief Title
    Effect of Using Different Varnishes on Dentin Hypersensitivity; Na Fluoride and Nano-silver Fluoride
    Official Title
    Effectiveness of Using Nano-Silver Fluoride Varnish Versus Sodium Fluoride Varnish in Management of Cervical Dentin Hypersensitivity in Adult Patients: A Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2021 (Anticipated)
    Primary Completion Date
    January 1, 2022 (Anticipated)
    Study Completion Date
    January 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Nayera Hassanien Mohamed

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    2 different varnishes will be used to test their effectiveness in controlling teeth hypersensitivity in adult patient.
    Detailed Description
    In-vivo part: Each varnish will be applied separately on different teeth according to the manufacturer's instructions and the VAS will be measured according to a specific timeline: T0 (baseline, before application of varnish), T1 (1 week after application), T2 (4 weeks after application) and T3 (4 weeks after application). In-situ part: Dentin specimen will be prepared from extracted teeth from the orthodontic department in our college, sterilized and prepared. it will be bonded to an orthodontic wire and bonded to upper first molar. Dentinal occlusion will be measured using scanning electron microscope following the same timeline.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Citrine 5% Sodium Fluoride
    Arm Type
    Active Comparator
    Arm Description
    It was developed to prolong the contact between the tooth surface and fluoride to increase the resistance against caries attack and manage tooth hypersensitivity; the active ingredient of fluoride varnish is mostly 5% sodium fluoride.
    Arm Title
    concocuted Nano-silver fluoride
    Arm Type
    Experimental
    Arm Description
    Nano-silver fluoride (NSF) is a laboratory synthesized solution
    Intervention Type
    Behavioral
    Intervention Name(s)
    Citrine 5 % sodium fluoride
    Intervention Description
    Citrine varnish is a 5% sodium fluoride varnish, It was developed to prolong the contact between the tooth surface and fluoride to increase the resistance against caries attack and manage tooth hypersensitivity; the active ingredient of fluoride varnish is mostly 5% sodium fluoride.
    Intervention Type
    Behavioral
    Intervention Name(s)
    concocted nano-silver fluoride
    Intervention Description
    Nano-silver fluoride (NSF) is a solution which has been introduced as an experimental formulation in which it's stability for three years has been proved by Santos et al. The laboratory synthesis of concocted NSF was carried out in a nano-technology center; Several trials were done until we have reached a successful end product.
    Primary Outcome Measure Information:
    Title
    change in dentin Hypersensitivity
    Description
    Visual Analogue Scale (VAS) will be used; 0 is no pain and 10 is severe pain. Pictures are added to the same, as well as colors to guide the patient during selection of pain severity.
    Time Frame
    1 week, 4 weeks & 8 weeks
    Secondary Outcome Measure Information:
    Title
    change in dentinal Tubule Occlusion
    Description
    the dentinal tubule occlusion of citrine 5% sodium fluoride and the dentinal tubule occlusion of nano-silver fluoride for treatment of dentin hypersensitivity and compare them together
    Time Frame
    1 week, 4 weeks * 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients consulting in one of the Qasr Einy, faculty of dentistry outpatient clinics. Males or females. Patient's age range 25-50 years. Patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bi-cuspids, and first molars with exposed cervical dentine) with teeth scoring Bpain (VAS score: greater than or equal to 3) during application of stimulus (airblast and tactile sensitivity test). Tooth with exposed root surface, complaining from hypersensitivity (VAS score; greater than or equal to 3). Patients accept the 2-months follow-up period. Provide informed consent. Exclusion Criteria: • Patients participating in another dental study that may alter the results of this study. A medical condition that could hinder the accuracy of pain reporting (e.g., pain disorders). Any chronic medical condition that requires the regular use of anti-inflammatory pain medications. Patients used or applied a desensitizing varnish within the last four weeks. Patients with dental problems; chipped teeth, defective restorations, fractured Un-displaced cuspids or deep dental caries. Lack of patient's approval and compliance.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Using Different Varnishes on Dentin Hypersensitivity; Na Fluoride and Nano-silver Fluoride

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