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Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish

Primary Purpose

Dentin Hypersensitivity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
polymeric nano calcium fluoride containing varnish NANO SEAL
Sponsored by
Samar Saad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity focused on measuring Dentin sensitivity ,nano calcium fluoride, nano fluorapatite,Casein Phosphopeptide Amorphous Calcium Phosphate.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with good oral hygiene.
  • The age range of 18-65 years.
  • Patients from both gender.
  • Patients suffering from pain due to dentin hypersensitivity.
  • hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bicuspids, and first molars with exposed cervical dentine).
  • non carious cervical lesions: abrasion,erosion, abfraction, and recession with cervical dentin exposure

Exclusion Criteria:

  • Patient with bad oral hygiene.
  • Patients with constant use of analgesic, antihistaminic, anticonvulsive, sedative, tranquilizing, or anti-inflammatory medications 72 hours before treatment and pain assessment.
  • patients having received any desensitizing treatment during the last 3 months.
  • Patients with allergy of any materials will be used in the study . teeth with pulpitis.
  • teeth with periodontal disease installed.
  • teeth exhibiting mobility (grade 2 or 3).
  • carious lesions, fractured teeth, defective restorations or prosthesis.
  • Patients with orthodontics appliance.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    polymeric nano calcium fluoride containing varnish, NANO SEAL.

    Casein Phosphopeptide Amorphous Calcium Phosphate Containing Fluoride Varnish,MI varnish

    Arm Description

    CPP-ACP with 5%NaF

    Outcomes

    Primary Outcome Measures

    Visual Analog Scale VAS
    from 0-10 Pain absent: 0 Low pain:(1-3) Moderate pain: (4-6) Intense pain: (7-9) Extremely intense pain: 10.
    Schiff air score
    from 0-3 0: Tooth/subject did not respond to the air stimulus. Tooth/subject responded to the air stimulus but did not request discontinuation of the stimulus. Tooth/subject responded to the air stimulus and requested discontinuation or moved from the stimulus. Tooth/subject responded to the air stimulus, considered the stimulus to be painful, and requested discontinuation.

    Secondary Outcome Measures

    Dentinal tubule occlusion
    Fully open, partially occluded and fully occluded dentinal tubules. (Percentage %)

    Full Information

    First Posted
    October 23, 2020
    Last Updated
    January 25, 2021
    Sponsor
    Samar Saad
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04614727
    Brief Title
    Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish
    Official Title
    Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish Versus Casein Phosphopeptide Amorphous Calcium Phosphate Containing Fluoride Varnish: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 10, 2021 (Anticipated)
    Primary Completion Date
    May 10, 2021 (Anticipated)
    Study Completion Date
    June 10, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Samar Saad

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate the Desensitizing efficacy of polymeric nano calcium fluoride containing varnish and its implementation into clinical practice.
    Detailed Description
    Increasing the demand to find a desensitizing agent that should be biocompatible, easy to apply, painless, not changing the dental color, fast onset, and maintain a long-term effect gives a highlight to the patented formula of the polymeric nano calcium fluoride which newly introduced into the practice . OliNano SEAL is an innovative "varnish-like" protector based on a patented silicone polymer with a true nano technology that provides an exceptional adhesion to enamel and dentin without prior etching for approximately 12 months (other available products max. 2-3 months). It consists of four components Silicone polymer provides excellent adhesion to enamel and dentine, with transparent formula. NANO-fluoroapatite flows into enamel micro cracks & seals it, penetrating into the dentinal tubules closing them eventually. As for the NANO-calcium fluoride it behaves as a fluoride reservoir, provides gradual and long-term fluoride release. The fourth component Amine fluoride (Olaflur) provides immediate fluoride ion release and accelerates natural remineralization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dentin Hypersensitivity
    Keywords
    Dentin sensitivity ,nano calcium fluoride, nano fluorapatite,Casein Phosphopeptide Amorphous Calcium Phosphate.

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    polymeric nano calcium fluoride containing varnish, NANO SEAL.
    Arm Type
    Experimental
    Arm Title
    Casein Phosphopeptide Amorphous Calcium Phosphate Containing Fluoride Varnish,MI varnish
    Arm Type
    Other
    Arm Description
    CPP-ACP with 5%NaF
    Intervention Type
    Combination Product
    Intervention Name(s)
    polymeric nano calcium fluoride containing varnish NANO SEAL
    Intervention Description
    It consists of four components Silicone polymer provides excellent adhesion to enamel and dentine, with transparent formula. NANO-fluoroapatite flows into enamel micro cracks & seals it, penetrating into the dentinal tubules closing them eventually. As for the NANO-calcium fluoride it behaves as a fluoride reservoir, provides gradual and long-term fluoride release. The fourth component Amine fluoride (Olaflur) provides immediate fluoride ion release and accelerates natural remineralization.
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale VAS
    Description
    from 0-10 Pain absent: 0 Low pain:(1-3) Moderate pain: (4-6) Intense pain: (7-9) Extremely intense pain: 10.
    Time Frame
    six months
    Title
    Schiff air score
    Description
    from 0-3 0: Tooth/subject did not respond to the air stimulus. Tooth/subject responded to the air stimulus but did not request discontinuation of the stimulus. Tooth/subject responded to the air stimulus and requested discontinuation or moved from the stimulus. Tooth/subject responded to the air stimulus, considered the stimulus to be painful, and requested discontinuation.
    Time Frame
    six months
    Secondary Outcome Measure Information:
    Title
    Dentinal tubule occlusion
    Description
    Fully open, partially occluded and fully occluded dentinal tubules. (Percentage %)
    Time Frame
    six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with good oral hygiene. The age range of 18-65 years. Patients from both gender. Patients suffering from pain due to dentin hypersensitivity. hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bicuspids, and first molars with exposed cervical dentine). non carious cervical lesions: abrasion,erosion, abfraction, and recession with cervical dentin exposure Exclusion Criteria: Patient with bad oral hygiene. Patients with constant use of analgesic, antihistaminic, anticonvulsive, sedative, tranquilizing, or anti-inflammatory medications 72 hours before treatment and pain assessment. patients having received any desensitizing treatment during the last 3 months. Patients with allergy of any materials will be used in the study . teeth with pulpitis. teeth with periodontal disease installed. teeth exhibiting mobility (grade 2 or 3). carious lesions, fractured teeth, defective restorations or prosthesis. Patients with orthodontics appliance.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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    Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish

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