Tooth HypersensitivityNCT04568473
Effectiveness of Bioactive Resin Varnish and Fluoride Containing Xylitol Varnish in Management of Teeth Hypersensitivity
A study testing PRG Barrier Coat (By SHOFU Inc., Japan) and EMBRACE™ Varnish by (Pulpdent Corporation, USA) in people with Tooth Hypersensitivity, run by Cairo University at 1 site in Egypt.
Trial 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? Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Tooth Hypersensitivity
- What is being tested?
- PRG Barrier Coat (By SHOFU Inc., Japan) and EMBRACE™ Varnish by (Pulpdent Corporation, USA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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?
Read the 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 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):
- Primary Outcome: Pain due to Hypersensitivity
- Secondary Outcome: Dentinal tubules occlusion
- Conditions
- Tooth Hypersensitivity
- Being tested
- PRG Barrier Coat (By SHOFU Inc., Japan), EMBRACE™ Varnish by (Pulpdent Corporation, USA)
- Keywords
- Hypersensitivity, Sodium Fluoride, Xylitol coated Calcium and Phosphate, BioSmart Light Cured Protective Shield
- Medical subject headings
- Dentin Sensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRG Barrier Coat (By SHOFU Inc., Japan)Other
Also called Bio-smart Light Cured Protective Shield with bioactive S-PRG (Surface Pre-Reacted Glass ionomer)
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)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: EMBRACE™ Varnish by (Pulpdent Corporation, USA) |
| 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 Receives: Other: PRG Barrier Coat (By SHOFU Inc., Japan) |
| 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. Receives: Other: PRG Barrier Coat (By SHOFU Inc., Japan); Other: EMBRACE™ Varnish by (Pulpdent Corporation, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 4 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
Measured: 8 weeks
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 8 weeks
Dentinal Tubule Occlusion
Scanning Electron Microscope and digital image analysis measuring the surface area of patent dentinal tubules
Measured: Baseline
Dentinal Tubule Occlusion
Scanning Electron Microscope and digital image analysis measuring the surface area of patent dentinal tubules
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start20 Sep 2021
- Primary completion31 Jan 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth HypersensitivityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Abd El-Fattah, Cairo University
- Investigators
- Heba AE Mohamed, Master's, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568473
- Sponsor's protocol ID
- CairoU-HAElFattah
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2020
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 40251520
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04568473
- Acronym / sponsor ID
- CairoU-HAElFattah
- Conditions
- Tooth Hypersensitivity
- Keywords
- Hypersensitivity, Sodium Fluoride, Xylitol coated Calcium and Phosphate, BioSmart Light Cured Protective Shield
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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):
- Primary Outcome: Pain due to Hypersensitivity
- Secondary Outcome: Dentinal tubules occlusion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRG Barrier Coat (SHOFU Inc., Japan) | Experimental | Other: EMBRACE™ Varnish by (Pulpdent Corporation, USA)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 | Other: PRG Barrier Coat (By SHOFU Inc., Japan)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 | Other: PRG Barrier Coat (By SHOFU Inc., Japan), Other: EMBRACE™ Varnish by (Pulpdent Corporation, USA)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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bicuspids, and first molars with exposed cervical dentin)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRG Barrier Coat (By SHOFU Inc., Japan)Also: Bio-smart Light Cured Protective Shield with bioactive S-PRG (Surface Pre-Reacted Glass ionomer)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 | Duraphat® (Colgate Palmolive Company, New York, NY), EMBRACE™ Varnish (Pulpdent Corporation, USA) |
| 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 | Duraphat® (Colgate Palmolive Company, New York, NY), PRG Barrier Coat (SHOFU Inc., Japan) |
Primary outcome
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
Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
Time frame: 3 minutes
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
Time frame: 2 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
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
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
12 secondary outcomes
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
Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
Time frame: 3 minutes
Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
Time frame: 2 weeks
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
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
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
Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
Time frame: 3 minutes
Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain
Time frame: 2 weeks
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
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
Dentinal Tubule Occlusion
Time frame: Baseline
Dentinal Tubule Occlusion
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Derived from this study: PubMed 40251520Abd 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heba AE Mohamed, Master's principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRG Barrier Coat (By SHOFU Inc., Japan) and EMBRACE™ Varnish by (Pulpdent Corporation, USA) in people with Tooth Hypersensitivity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04568473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.