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

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

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?

Study Overview

• Status: Completed
• Conditions: Hypersensitivity Dentin; Tooth Hypersensitivity
• Intervention / Treatment: Combination product: Sylc; Combination product: fluoride varnish (Bifluorid 10)

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt
      • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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; Other Names: Sylc bioactive glass
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.	Combination product: fluoride varnish (Bifluorid 10); It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.; Other Names: Bifluorid 10

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Dina E Mohamed, Master, Assistant lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Bifluoride, sylc, hypersensitivity,
• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Fluorides, Topical
• Other Study ID Numbers: CairoU-DEzz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No