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Effectiveness of Bioactive Resin Varnish and Fluoride Containing Xylitol Varnish in Management of Teeth Hypersensitivity

Primary Purpose

Tooth Hypersensitivity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRG Barrier Coat (By SHOFU Inc., Japan)
EMBRACE™ Varnish by (Pulpdent Corporation, USA)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Hypersensitivity focused on measuring Hypersensitivity, Sodium Fluoride, Xylitol coated Calcium and Phosphate, BioSmart Light Cured Protective Shield

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bicuspids, and first molars with exposed cervical dentin)

    • Teeth scoring pain (VAS score: greater than or equal to 3) during application of stimulus (air blast and tactile sensitivity test).
    • Tooth with exposed root surface, complaining from hypersensitivity (VAS score; greater than or equal to 3).
    • Patients with good oral hygiene.
    • Co-operative patients who show interest to participate in the study accept the 2-months follow-up period.

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.
  • Patients with orthodontic appliances, or bridge work that might interfere with evaluation
  • Lack of patient's approval and compliance.
  • Patients who are allergic to any ingredients will be used in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    PRG Barrier Coat (SHOFU Inc., Japan)

    EMBRACE™ Varnish (Pulpdent Corporation, USA)

    Duraphat® (Colgate Palmolive Company, New York, NY)

    Arm Description

    BioSmart Light Cured Protective Shield with bioactive S-PRG (Surface Pre-Reacted Glass ionomer) filler technology. S-PRG filler possesses a three-layer structure with a stabilized glass-ionomer-like structure surrounding multifunctional glass fillers, and is subsequently protected by a surface modified layer.

    Resin-based 5% sodium fluoride with CXP™ (Xylitol-coated Calcium and Phosphate) technology for unsurpassed fluoride release. The incorporation of CXP™ (xylitol-coated calcium and phosphate) in a permeable resin matrix that does not separate, purportedly drives the sustained, time-released properties of this varnish

    It is attributed to the reactivity of the fluoride by adsorbing to the surface and attracting calcium ions forming loosely-bound calcium fluoride (CaF2)- like reservoir which is also considered responsible for the anticaries mechanism and protection against cariogenic acid attack.

    Outcomes

    Primary Outcome Measures

    Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Amount of Pain arising from dentin hypersensitivity in non-carious cervical lesions stimulated by air blast measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Pain arising from dentin hypersensitivity in non-carious cervical lesions stimulated by air blast measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Pain arising from dentin hypersensitivity in non-carious cervical lesions stimulated by air blast measured by a 10 cm Visual Analogue Scale (from 0 to 10) . Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Pain arising from dentin hypersensitivity in non-carious cervical lesions stimulated by air blast measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort

    Secondary Outcome Measures

    Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Dentinal Tubule Occlusion
    Scanning Electron Microscope and using image analysis, Fully open, Partially Occluded and Fully Occluded Dentinal Tubules (Percentage) (0%) indicates no occluded Dentinal tubules, while (100%) indicates total blockage of Dentinal Tubules
    Dentinal Tubule Occlusion
    Scanning Electron Microscope and using image analysis, Fully open, Partially Occluded and Fully Occluded Dentinal Tubules (Percentage) (0%) indicates no occluded Dentinal tubules, while (100%) indicates total blockage of Dentinal Tubules

    Full Information

    First Posted
    September 18, 2020
    Last Updated
    September 23, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04568473
    Brief Title
    Effectiveness of Bioactive Resin Varnish and Fluoride Containing Xylitol Varnish in Management of Teeth Hypersensitivity
    Official Title
    Effectiveness of Bioactive Resin Based Varnish and Fluoride Varnish Containing Xylitol-coated Particles Versus Sodium Fluoride Varnish in Management of Teeth Hypersensitivity in Adult Patients Over Eight Weeks: A Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 20, 2020 (Anticipated)
    Primary Completion Date
    January 31, 2021 (Anticipated)
    Study Completion Date
    June 30, 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
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Will the use of Bio-smart Light Cured Protective Shield with bioactive S-PRG filler or the use of Sodium Fluoride with Xylitol-coated Calcium and Phosphate (CXP™) Varnish be able to reduce the teeth hypersensitivity similar to Sodium Fluoride Varnish?
    Detailed Description
    The null hypothesis tested in this study, that there is no difference in clinical effectiveness between bio-smart Shield with bioactive S-PRG filler and Fluoride varnish containing Xylitol-coated Calcium and Phosphate (CXP™) Compared to Sodium Fluoride Varnish in management of hypersensitivity in adult patients after 1, 4 and 8 weeks. P (Population): Patient with Teeth Hypersensitivity. Intervention-1: Bio-smart Light Cured Protective Shield with bioactive S-PRG (Surface Pre-Reacted Glass ionomer) filler technology (PRG Barrier Coat) by (By SHOFU Inc., Japan). Intervention-2: 5% Sodium Fluoride with Xylitol-coated Calcium and Phosphate (CXP™) Varnish (Embrace™ Varnish) by (Pulpdent Corporation) C (Comparator): 5% Sodium Fluoride Varnish (Duraphat®) by (Colgate Palmolive Company, New York, NY) O (Outcome): Primary Outcome: Pain due to Hypersensitivity Secondary Outcome: Mineral Content

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Hypersensitivity
    Keywords
    Hypersensitivity, Sodium Fluoride, Xylitol coated Calcium and Phosphate, BioSmart Light Cured Protective Shield

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    21 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PRG Barrier Coat (SHOFU Inc., Japan)
    Arm Type
    Experimental
    Arm Description
    BioSmart Light Cured Protective Shield with bioactive S-PRG (Surface Pre-Reacted Glass ionomer) filler technology. S-PRG filler possesses a three-layer structure with a stabilized glass-ionomer-like structure surrounding multifunctional glass fillers, and is subsequently protected by a surface modified layer.
    Arm Title
    EMBRACE™ Varnish (Pulpdent Corporation, USA)
    Arm Type
    Experimental
    Arm Description
    Resin-based 5% sodium fluoride with CXP™ (Xylitol-coated Calcium and Phosphate) technology for unsurpassed fluoride release. The incorporation of CXP™ (xylitol-coated calcium and phosphate) in a permeable resin matrix that does not separate, purportedly drives the sustained, time-released properties of this varnish
    Arm Title
    Duraphat® (Colgate Palmolive Company, New York, NY)
    Arm Type
    Active Comparator
    Arm Description
    It is attributed to the reactivity of the fluoride by adsorbing to the surface and attracting calcium ions forming loosely-bound calcium fluoride (CaF2)- like reservoir which is also considered responsible for the anticaries mechanism and protection against cariogenic acid attack.
    Intervention Type
    Other
    Intervention Name(s)
    PRG Barrier Coat (By SHOFU Inc., Japan)
    Other Intervention Name(s)
    Bio-smart Light Cured Protective Shield with bioactive S-PRG (Surface Pre-Reacted Glass ionomer)
    Intervention Description
    PRG Barrier Coat (By SHOFU Inc., Japan) is a bioactive, resin-based varnish based on the proprietary Giomer concept which incorporates the patented bioactive S-PRG (Surface Pre-Reacted Glass ionomer) filler technology, where a unique combination of six beneficial ions are actively gradually released to provide a smart solution to revolutionize dentin hypersensitivity protocol
    Intervention Type
    Other
    Intervention Name(s)
    EMBRACE™ Varnish by (Pulpdent Corporation, USA)
    Intervention Description
    5% sodium fluoride with CXP™ (Xylitol-coated Calcium and Phosphate) technology for unsurpassed fluoride release and it is considered as a novel method of delivering remineralizing ions (Calcium and Phosphate) in combination with xylitol. The incorporation of CXP™ in a permeable resin matrix that does not separate, purportedly drives the sustained, time-released properties of this varnish.it has ten times more fluoride release over a 4-hour period than the leading varnish brand, in addition, it also releases bioavailable calcium and phosphate ions which are nano-coated with xylitol.
    Primary Outcome Measure Information:
    Title
    Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Description
    Amount of Pain arising from dentin hypersensitivity in non-carious cervical lesions stimulated by air blast measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Time Frame
    Baseline
    Title
    Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Description
    Pain arising from dentin hypersensitivity in non-carious cervical lesions stimulated by air blast measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Time Frame
    1 week
    Title
    Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Description
    Pain arising from dentin hypersensitivity in non-carious cervical lesions stimulated by air blast measured by a 10 cm Visual Analogue Scale (from 0 to 10) . Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Time Frame
    4 weeks
    Title
    Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Description
    Pain arising from dentin hypersensitivity in non-carious cervical lesions stimulated by air blast measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Description
    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Time Frame
    Baseline
    Title
    Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Description
    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Time Frame
    1 week
    Title
    Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Description
    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Time Frame
    4 weeks
    Title
    Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Description
    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Time Frame
    8 weeks
    Title
    Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Description
    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Time Frame
    Baseline
    Title
    Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Description
    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Time Frame
    1 week
    Title
    Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Description
    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Time Frame
    4 weeks
    Title
    Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
    Description
    Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm Visual Analogue Scale (from 0 to 10). Dentin hypersensitivity will be measured, with the score of zero being a pain-free response and score of 10 being excruciating pain or discomfort
    Time Frame
    8 weeks
    Title
    Dentinal Tubule Occlusion
    Description
    Scanning Electron Microscope and using image analysis, Fully open, Partially Occluded and Fully Occluded Dentinal Tubules (Percentage) (0%) indicates no occluded Dentinal tubules, while (100%) indicates total blockage of Dentinal Tubules
    Time Frame
    Baseline
    Title
    Dentinal Tubule Occlusion
    Description
    Scanning Electron Microscope and using image analysis, Fully open, Partially Occluded and Fully Occluded Dentinal Tubules (Percentage) (0%) indicates no occluded Dentinal tubules, while (100%) indicates total blockage of Dentinal Tubules
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bicuspids, and first molars with exposed cervical dentin) Teeth scoring pain (VAS score: greater than or equal to 3) during application of stimulus (air blast and tactile sensitivity test). Tooth with exposed root surface, complaining from hypersensitivity (VAS score; greater than or equal to 3). Patients with good oral hygiene. Co-operative patients who show interest to participate in the study accept the 2-months follow-up period. 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. Patients with orthodontic appliances, or bridge work that might interfere with evaluation Lack of patient's approval and compliance. Patients who are allergic to any ingredients will be used in the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heba AE Mohamed, Master's
    Phone
    1006126616
    Ext
    +20
    Email
    hebaabdelfattah1987@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dina EE Mohamed, Doctorate
    Phone
    1008007157
    Ext
    +20
    Email
    dina.ezz@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Heba AE Mohamed, Master's
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The personal data of the participants will not present on the protocol form and it would be maintained secured for 10 years after the trial for protection of participants' privacy and civil rights.

    Learn more about this trial

    Effectiveness of Bioactive Resin Varnish and Fluoride Containing Xylitol Varnish in Management of Teeth Hypersensitivity

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