- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03285360
Effectiveness of Bioactiveglass Air Abrasion Versus Fluoride Varnish in Management of Dentin Hypersensitivity
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 Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt
- Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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:
|
a dry powder (calcium sodium phosphosilicate), based on NovaMin powder.
Bottle of small and coarse particles will be used for the treatment
Other Names:
|
Active Comparator: 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:
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. |
It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain due to dentin hypersensitivity (evaporative stimulus)
Time Frame: 2 minutes after treatment
|
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)
Time Frame: 1 week
|
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)
Time Frame: 2 weeks
|
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)
Time Frame: 3 weeks
|
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)
Time Frame: 4 weeks
|
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)
Time Frame: 6 months
|
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)
Time Frame: 12 months
|
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)
Time Frame: 2 minutes after treatment
|
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)
Time Frame: 1 week
|
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)
Time Frame: 2 weeks
|
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)
Time Frame: 3 weeks
|
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)
Time Frame: 4 weeks
|
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)
Time Frame: 6 months
|
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)
Time Frame: 12 months
|
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)
Time Frame: 2 minutes after treatment
|
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)
Time Frame: 1 week
|
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)
Time Frame: 2 weeks
|
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)
Time Frame: 3 weeks
|
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)
Time Frame: 4 weeks
|
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)
Time Frame: 6 months
|
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)
Time Frame: 12 months
|
Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dina E Mohamed, Master, Assistant lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CairoU-DEzz
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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