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

Not Applicable

Completed

• Conditions: Tooth Hypersensitivity

• 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

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-29
• Study Start: 2021-09-20
• Primary Completion: 2024-01-31
• Study Completion: 2024-06-30
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

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