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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hypersensitivity Dentin, Tooth Hypersensitivity

Intervention / Treatment
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* Combination Product: Sylc
* Combination Product: fluoride varnish (Bifluorid 10)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Dentin Hypersensitivity
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sylc bioactive glass<br>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<br>* a dry powder (calcium sodium phosphosilicate), based on NovaMin powder. Bottle of small and coarse particles will be used for the treatment<br>* Other names: Sylc bioactive glass;|
| Active Comparator: fluoride varnish (Bifluorid 10)<br>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)<br>* It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.<br>* Other names: Bifluorid 10;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bifluoride, sylc, hypersensitivity,