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

NCT ID: NCT03285360

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-01-01

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

Conditions

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Hypersensitivity Dentin Tooth Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Dentin Hypersensitivity
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
double blinded

Study Groups

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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:

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.

Group Type EXPERIMENTAL

Sylc

Intervention Type COMBINATION_PRODUCT

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)

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.

Group Type ACTIVE_COMPARATOR

fluoride varnish (Bifluorid 10)

Intervention Type COMBINATION_PRODUCT

It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.

Interventions

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Sylc

a dry powder (calcium sodium phosphosilicate), based on NovaMin powder. Bottle of small and coarse particles will be used for the treatment

Intervention Type COMBINATION_PRODUCT

fluoride varnish (Bifluorid 10)

It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Sylc bioactive glass Bifluorid 10

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Dina Ezz

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina E Mohamed, Master

Role: PRINCIPAL_INVESTIGATOR

Assistant lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University

Locations

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Faculty of dentistry

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CairoU-DEzz

Identifier Type: -

Identifier Source: org_study_id

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