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

Phase 1

Completed

• Conditions: Hypersensitivity Dentin; Tooth Hypersensitivity
• Interventions: Combination Product: fluoride varnish (Bifluorid 10); Combination Product: Sylc

• Registration Number: NCT03285360
• Lead Sponsor: Cairo University

Brief Summary

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?

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 Timeline

• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-14
• Study First Posted: 2017-09-18
• Study Start: 2017-10-01
• Primary Completion: 2018-12-01
• Status Verified: 2019-01
• Study Completion: 2019-01-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fluoride varnish (Bifluorid 10)	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: 1. Preparation: The tooth will be properly cleaned, and the surface will be air-dried. 2. Dispensing: The foil will be pierced using a micro- tim, the opening will be enlarged, the brush will be wet in a circular movement. 3. 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.
sylc bioactive glass	Sylc	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: 1. Isolation: D.M. will make proper isolation for the teeth using cotton rolls. 2. Hand piece: NSK Prophymate Neo will be used to deliver the powder particles on the sensitive areas. Air stream adjusted at 40-46 psi. 3. 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. 4. Suction: High volume suction will be used on lingual side of the teeth to suck any particles, and avoid patient from swallowing it.

Primary Outcome Measures

Name	Time	Method
Pain due to dentin hypersensitivity (evaporative stimulus)	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 Outcome Measures

Name	Time	Method
Pain due to dentin hypersensitivity (tactile stimulus)	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)	12 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 (evaporative stimulus)	12 months	Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS

Trial Locations

Locations (1)

Faculty of dentistry; 🇪🇬 Cairo, Cairo Governorate, Egypt