Effectiveness of Bioactive Resin Varnish and Fluoride Containing Xylitol Varnish in Management of Teeth Hypersensitivity
- Conditions
- Tooth Hypersensitivity
- Interventions
- Other: PRG Barrier Coat (By SHOFU Inc., Japan)Other: EMBRACE™ Varnish by (Pulpdent Corporation, USA)
- Registration Number
- NCT04568473
- Lead Sponsor
- Cairo University
- 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 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EMBRACE™ Varnish (Pulpdent Corporation, USA) 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 PRG Barrier Coat (SHOFU Inc., Japan) 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. Duraphat® (Colgate Palmolive Company, New York, NY) PRG Barrier Coat (By SHOFU Inc., Japan) 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. Duraphat® (Colgate Palmolive Company, New York, NY) 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.
- Primary Outcome Measures
Name Time Method Amount of pain due to dentin hypersensitivity (evaporative stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain 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
Name Time Method Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain 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
Amount of pain due to dentin hypersensitivity (Tactile stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain 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
Dentinal Tubule Occlusion 8 weeks Scanning Electron Microscope and digital image analysis measuring the surface area of patent dentinal tubules
Trial Locations
- Locations (1)
Cairo University
🇪🇬Cairo, Manial, Egypt