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

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ClinicalTrials.gov Identifier: NCT04568473
Recruitment Status : Not yet recruiting
First Posted : September 29, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Heba Abd El-Fattah, Cairo University

Study Description
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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?

Condition or disease Intervention/treatment Phase
Tooth Hypersensitivity Other: PRG Barrier Coat (By SHOFU Inc., Japan) Other: EMBRACE™ Varnish by (Pulpdent Corporation, USA) Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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.
Estimated Study Start Date : October 20, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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Arm Intervention/treatment
Experimental: PRG Barrier Coat (SHOFU Inc., Japan)

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.

 Other: EMBRACE™ Varnish by (Pulpdent Corporation, USA)
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.
Experimental: EMBRACE™ Varnish (Pulpdent Corporation, USA)

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

 Other: PRG Barrier Coat (By SHOFU Inc., Japan)
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
Other Name: Bio-smart Light Cured Protective Shield with bioactive S-PRG (Surface Pre-Reacted Glass ionomer)
Active Comparator: Duraphat® (Colgate Palmolive Company, New York, NY)
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.
 Other: PRG Barrier Coat (By SHOFU Inc., Japan)
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
Other Name: Bio-smart Light Cured Protective Shield with bioactive S-PRG (Surface Pre-Reacted Glass ionomer)

Other: EMBRACE™ Varnish by (Pulpdent Corporation, USA)
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.


Outcome Measures
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Primary Outcome Measures :
  1. Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain [ Time Frame: Baseline ]
    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

  2. Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain [ Time Frame: 1 week ]
    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

  3. Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain [ Time Frame: 4 weeks ]
    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

  4. Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain [ Time Frame: 8 weeks ]
    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 :
  1. Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain [ Time Frame: Baseline ]
    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

  2. Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain [ Time Frame: 1 week ]
    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

  3. Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain [ Time Frame: 4 weeks ]
    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

  4. Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain [ Time Frame: 8 weeks ]
    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

  5. Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain [ Time Frame: Baseline ]
    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

  6. Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain [ Time Frame: 1 week ]
    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

  7. Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain [ Time Frame: 4 weeks ]
    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

  8. Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain [ Time Frame: 8 weeks ]
    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

  9. Dentinal Tubule Occlusion [ Time Frame: Baseline ]
    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

  10. Dentinal Tubule Occlusion [ Time Frame: 8 weeks ]
    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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568473


Contacts
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Contact: Heba AE Mohamed, Master's 1006126616 ext +20 hebaabdelfattah1987@gmail.com
Contact: Dina EE Mohamed, Doctorate 1008007157 ext +20 dina.ezz@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Heba AE Mohamed, Master's Cairo University
More Information
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Responsible Party: Heba Abd El-Fattah, Assistant Lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT04568473    
Other Study ID Numbers: CairoU-HAElFattah
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heba Abd El-Fattah, Cairo University:
Hypersensitivity
Sodium Fluoride
Xylitol coated Calcium and Phosphate
BioSmart Light Cured Protective Shield
Additional relevant MeSH terms:
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Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases