Effectiveness of Bioactiveglass Air Abrasion Versus Fluoride Varnish in Management of Dentin Hypersensitivity

Overview

Will the use of Bioactive glass with air abrasion technology (Sylc) compared to Fluoride Varnish (Biflourid 10) affects the degree of pain in patients complaining from hypersensitivity due to non-carious lesions?

Full Title of Study: “Effectiveness of Sylc Air Abrasion Bioactive Glass Technology Versus Fluoride Varnish Application in Management of Hypersensitivity of Non-Carious Cervical Lesions: Randomized Clinical Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 1, 2018

Detailed Description

– Population: Patients complaining from Dentin Hypersensitivity due to non-carious lesions. – Intervention: Sylc, Air Abrasion Bioactive glass (Denfotex Research Ltd.) – Comparison: BiFlourid 10, Fluoride Varnish (VOCO, Germany) – Outcome measures: Dentin Hypersensitivity Outcome name Measuring device Measuring unit Dentin Hypersensitivity – Thermal – Tactile – Evaporative

Interventions

  • Combination Product: Sylc
    • a dry powder (calcium sodium phosphosilicate), based on NovaMin powder. Bottle of small and coarse particles will be used for the treatment
  • Combination Product: fluoride varnish (Bifluorid 10)
    • It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.

Arms, Groups and Cohorts

  • Experimental: sylc bioactive glass
    • Sylc is a dry powder (calcium sodium phosphosilicate), based on NovaMin powder. Bottle of small and coarse particles will be used for the treatment. Steps: Isolation: D.M. will make proper isolation for the teeth using cotton rolls. Hand piece: NSK Prophymate Neo will be used to deliver the powder particles on the sensitive areas. Air stream adjusted at 40-46 psi. Application: The hand piece will be held at constant distance (3-4mm) away from the tooth surface, with 60-80 degrees on the buccal surfaces. The powder will be applied for 5-10 seconds per tooth in a circular movement. Suction: High volume suction will be used on lingual side of the teeth to suck any particles, and avoid patient from swallowing it.
  • Active Comparator: fluoride varnish (Bifluorid 10)
    • fluoride varnish Bifluorid 10(by VOCO) will be used. It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride. The single dose form will be used, to make sure the amount of fluoride varnish used is standardized. Steps: Preparation: The tooth will be properly cleaned, and the surface will be air-dried. Dispensing: The foil will be pierced using a micro- tim, the opening will be enlarged, the brush will be wet in a circular movement. Application: Thin coat will be applied on the tooth surface. The varnish will be left from 10-20 seconds then air dried. Concerning the storage of the Bifluoride 10, it will be stored in refrigerator at the operative clinic to avoid exposure to high temperature or sunlight.

Clinical Trial Outcome Measures

Primary Measures

  • Pain due to dentin hypersensitivity (evaporative stimulus)
    • Time Frame: 2 minutes after treatment
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS

Secondary Measures

  • Pain due to dentin hypersensitivity (evaporative stimulus)
    • Time Frame: 1 week
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS
  • Pain due to dentin hypersensitivity (evaporative stimulus)
    • Time Frame: 2 weeks
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS
  • Pain due to dentin hypersensitivity (evaporative stimulus)
    • Time Frame: 3 weeks
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS
  • Pain due to dentin hypersensitivity (evaporative stimulus)
    • Time Frame: 4 weeks
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS
  • Pain due to dentin hypersensitivity (evaporative stimulus)
    • Time Frame: 6 months
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS
  • Pain due to dentin hypersensitivity (evaporative stimulus)
    • Time Frame: 12 months
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS
  • Pain due to dentin hypersensitivity (tactile stimulus)
    • Time Frame: 2 minutes after treatment
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS
  • Pain due to dentin hypersensitivity (tactile stimulus)
    • Time Frame: 1 week
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS
  • Pain due to dentin hypersensitivity (tactile stimulus)
    • Time Frame: 2 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 VAS
  • Pain due to dentin hypersensitivity (tactile stimulus)
    • Time Frame: 3 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 VAS
  • Pain due to dentin hypersensitivity (tactile stimulus)
    • Time Frame: 4 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 VAS
  • Pain due to dentin hypersensitivity (tactile stimulus)
    • Time Frame: 6 months
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS
  • Pain due to dentin hypersensitivity (tactile stimulus)
    • Time Frame: 12 months
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS
  • Pain due to dentin hypersensitivity (thermal stimulus)
    • Time Frame: 2 minutes after treatment
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS
  • Pain due to dentin hypersensitivity (thermal stimulus)
    • Time Frame: 1 week
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS
  • Pain due to dentin hypersensitivity (thermal stimulus)
    • Time Frame: 2 weeks
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS
  • Pain due to dentin hypersensitivity (thermal stimulus)
    • Time Frame: 3 weeks
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS
  • Pain due to dentin hypersensitivity (thermal stimulus)
    • Time Frame: 4 weeks
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS
  • Pain due to dentin hypersensitivity (thermal stimulus)
    • Time Frame: 6 months
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS
  • Pain due to dentin hypersensitivity (thermal stimulus)
    • Time Frame: 12 months
    • Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS

Participating in This Clinical Trial

Inclusion Criteria

  • Males or females. – Age: 18-70 years old. – Patients with good oral hygiene. – Co-operative patients who show interest to participate in the study. Exclusion Criteria:

  • Patients with bad oral hygiene. – Patients with orthodontic appliances, or bridge work that might interfere with evaluation. – Patients who did any periodontal surgeries within the previous 6 months. – Patients who are allergic to any ingredients will be used in the study. – Pregnant and lactating women.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dina Ezz, Principal investigator – Cairo University
  • Overall Official(s)
    • Dina E Mohamed, Master, Principal Investigator, Assistant lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University

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