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

NCT04568473 | Completed

• 1 other identifier: CairoU-HAElFattah
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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?

Conditions

Tooth Hypersensitivity

Keywords

Hypersensitivity; Sodium Fluoride; Xylitol coated Calcium and Phosphate; BioSmart Light Cured Protective Shield

Outcome Measures

Primary Outcomes (5)

• 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

• 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

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

  Baseline

• Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain

  3 minutes

• Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain

  2 weeks

• Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain

  4 weeks

• Amount of pain due to dentin hypersensitivity (Thermal stimulus) using Visual Analogue Scale, (0) indicates No Pain and (10) indicates maximum Pain

  8 weeks

Study Arms (3)

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.

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

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.

Other: PRG Barrier Coat (By SHOFU Inc., Japan); Other: EMBRACE™ Varnish by (Pulpdent Corporation, USA)

Interventions

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

Also known as: Bio-smart Light Cured Protective Shield with bioactive S-PRG (Surface Pre-Reacted Glass ionomer)

Duraphat® (Colgate Palmolive Company, New York, NY); EMBRACE™ Varnish (Pulpdent Corporation, USA)

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.

Duraphat® (Colgate Palmolive Company, New York, NY); PRG Barrier Coat (SHOFU Inc., Japan)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Manial, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40251520 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity; Hypersensitivity

Interventions

PRG Barrier Coat

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Study Officials

• Heba AE Mohamed, Master's

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 29, 2020
• Study Start: September 20, 2021
• Primary Completion: January 31, 2024
• Study Completion: June 30, 2024
• Last Updated: February 17, 2025

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)