Effectiveness of Bioactive Resin Varnish and Fluoride Containing Xylitol Varnish in Management of Teeth Hypersensitivity
NCT ID: NCT04568473
Last Updated: 2025-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2021-09-20
2024-06-30
Brief Summary
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Detailed Description
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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: Dentinal tubules occlusion
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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
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
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.
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
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.
Interventions
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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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Teeth scoring pain (VAS score: greater than or equal to 5) during application of stimulus (air blast, thermal and tactile sensitivity test).
* 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
* 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.
20 Years
50 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Heba Abd El-Fattah
Assistant Lecturer
Principal Investigators
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Heba AE Mohamed, Master's
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Cairo University
Cairo, Manial, Egypt
Countries
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References
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Abd El-Fattah Mohamed H, Ezzeldin Mohamed D, Hassanein E, Salah El-Din Hamza HE. In vivo and in situ evaluation of innovative approaches in dentin hypersensitivity treatment. BMC Oral Health. 2025 Apr 18;25(1):593. doi: 10.1186/s12903-025-05865-y.
Other Identifiers
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CairoU-HAElFattah
Identifier Type: -
Identifier Source: org_study_id
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