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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?
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 3 minutes, 2, 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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRG Barrier Coat (SHOFU Inc., Japan) | Experimental | 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 (Pulpdent Corporation, USA) | Experimental | 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 |
|
| Duraphat® (Colgate Palmolive Company, New York, NY) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRG Barrier Coat (By SHOFU Inc., Japan) | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| 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 | 3 minutes |
| 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 | 2 weeks |
| 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 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bicuspids, and first molars with exposed cervical dentin)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heba AE Mohamed, Master's | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Manial | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40251520 | Derived | 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. |
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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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| EMBRACE™ Varnish by (Pulpdent Corporation, USA) | Other | 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. |
|
| 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 |
| 8 weeks |
| Baseline |
| 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 | 3 minutes |
| 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 | 2 weeks |
| 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 | 4 weeks |
| 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 | 8 weeks |
| 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 | Baseline |
| 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 | 3 minutes |
| 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 | 2 weeks |
| 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 | 4 weeks |
| 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 | 8 weeks |
| Dentinal Tubule Occlusion | Scanning Electron Microscope and digital image analysis measuring the surface area of patent dentinal tubules | Baseline |
| Dentinal Tubule Occlusion | Scanning Electron Microscope and digital image analysis measuring the surface area of patent dentinal tubules | 8 weeks |
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000612974 | PRG Barrier Coat |
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