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

Primary Purpose

Hypersensitivity Dentin, Tooth Hypersensitivity

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Sylc
fluoride varnish (Bifluorid 10)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypersensitivity Dentin focused on measuring Bifluoride, sylc, hypersensitivity,

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sylc bioactive glass

fluoride varnish (Bifluorid 10)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Full Information

First Posted
September 11, 2017
Last Updated
January 30, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03285360
Brief Title
Effectiveness of Bioactiveglass Air Abrasion Versus Fluoride Varnish in Management of Dentin Hypersensitivity
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity Dentin, Tooth Hypersensitivity
Keywords
Bifluoride, sylc, hypersensitivity,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Dentin Hypersensitivity
Masking
ParticipantOutcomes Assessor
Masking Description
double blinded
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sylc bioactive glass
Arm Type
Experimental
Arm Description
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.
Arm Title
fluoride varnish (Bifluorid 10)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Sylc
Other Intervention Name(s)
Sylc bioactive glass
Intervention Description
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
Intervention Name(s)
fluoride varnish (Bifluorid 10)
Other Intervention Name(s)
Bifluorid 10
Intervention Description
It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.
Primary Outcome Measure Information:
Title
Pain due to dentin hypersensitivity (evaporative stimulus)
Description
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
Secondary Outcome Measure Information:
Title
Pain due to dentin hypersensitivity (evaporative stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (evaporative stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (evaporative stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (evaporative stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (evaporative stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (evaporative stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (tactile stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (tactile stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (tactile stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (tactile stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (tactile stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (tactile stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (tactile stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (thermal stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (thermal stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (thermal stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (thermal stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (thermal stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (thermal stimulus)
Description
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
Title
Pain due to dentin hypersensitivity (thermal stimulus)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina E Mohamed, Master
Organizational Affiliation
Assistant lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of dentistry
City
Cairo
State/Province
Cairo Governorate
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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