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

Tooth Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03285360
• Other study ID #: CairoU-DEzz
• Status: Completed
• Phase: Phase 1
• Start date: October 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity
• Hypersensitivity Dentin
• Tooth Hypersensitivity

Intervention

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
• fluoride varnish (Bifluorid 10)
It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.

Locations

Country	Name	City	State
Egypt	Faculty of dentistry	Cairo	Cairo Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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