A Phase 1 interventional study of Sylc and fluoride varnish (Bifluorid 10) in Hypersensitivity Dentin and Tooth Hypersensitivity, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-31.
Sponsored by Cairo University · Phase 1, Interventional, and Treatment
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?
Outcome name Measuring device Measuring unit Dentin Hypersensitivity
Exclusion Criteria:
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.
Combination Product: Sylc
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.
Combination Product: fluoride varnish (Bifluorid 10)
a dry powder (calcium sodium phosphosilicate), based on NovaMin powder. Bottle of small and coarse particles will be used for the treatment
Also known as: Sylc bioactive glass
It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.
Also known as: Bifluorid 10
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
Time frame: 2 minutes after treatment
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
Plan to share: Undecided
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Cairo University