Hypersensitivity DentinPhase 1NCT03285360
Effectiveness of Bioactiveglass Air Abrasion Versus Fluoride Varnish in Management of Dentin Hypersensitivity
A Phase 1 study testing Sylc and fluoride varnish (Bifluorid 10) in people with Hypersensitivity Dentin and Tooth Hypersensitivity, run by Cairo University at 1 site in Egypt.
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? Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersensitivity Dentin, Tooth Hypersensitivity
- What is being tested?
- Sylc and fluoride varnish (Bifluorid 10)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 1 Jan 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females.
- Age: 18-70 years old.
- Patients with good oral hygiene.
- Co-operative patients who show interest to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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?
Read the 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
- Conditions
- Hypersensitivity Dentin, Tooth Hypersensitivity
- Being tested
- Sylc, fluoride varnish (Bifluorid 10)
- Keywords
- Bifluoride, sylc, hypersensitivity,
- Medical subject headings
- Dentin Sensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SylcCombination product
Also called Sylc bioactive glass
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)Combination product
Also called Bifluorid 10
It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.
| Study group | Role | What they receive |
|---|---|---|
| sylc bioactive glass | Experimental | 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. Receives: Combination Product: Sylc |
| fluoride varnish (Bifluorid 10) | Active comparator | 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. Receives: Combination Product: fluoride varnish (Bifluorid 10) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 minutes after treatment
Secondary outcomes (20)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start1 Oct 2017
- Primary completion1 Dec 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersensitivity DentinStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dentin Hypersensitivity
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ezz, Cairo University
- Investigators
- Dina E Mohamed, Master, Principal investigator, Assistant lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285360
- Sponsor's protocol ID
- CairoU-DEzz
- Status last verified
- Jan 2019
- First submitted
- 11 Sep 2017
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03285360
- Acronym / sponsor ID
- CairoU-DEzz
- Conditions
- Hypersensitivity Dentin, Tooth Hypersensitivity
- Keywords
- Bifluoride, sylc, hypersensitivity,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Dentin Hypersensitivity
| Arm | Type | Receives |
|---|---|---|
| sylc bioactive glass | Experimental | Combination Product: SylcSylc 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. |
| fluoride varnish (Bifluorid 10) | Active comparator | Combination Product: 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females.
- Age: 18-70 years old.
- Patients with good oral hygiene.
- Co-operative patients who show interest to participate in the study.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SylcAlso: Sylc bioactive glassa dry powder (calcium sodium phosphosilicate), based on NovaMin powder. Bottle of small and coarse particles will be used for the treatment | Combination product | sylc bioactive glass |
| fluoride varnish (Bifluorid 10)Also: Bifluorid 10It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride. | Combination product | fluoride varnish (Bifluorid 10) |
Primary outcome
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
20 secondary outcomes
Pain due to dentin hypersensitivity (evaporative stimulus)
Time frame: 1 week
Pain due to dentin hypersensitivity (evaporative stimulus)
Time frame: 2 weeks
Pain due to dentin hypersensitivity (evaporative stimulus)
Time frame: 3 weeks
Pain due to dentin hypersensitivity (evaporative stimulus)
Time frame: 4 weeks
Pain due to dentin hypersensitivity (evaporative stimulus)
Time frame: 6 months
Pain due to dentin hypersensitivity (evaporative stimulus)
Time frame: 12 months
Pain due to dentin hypersensitivity (tactile stimulus)
Time frame: 2 minutes after treatment
Pain due to dentin hypersensitivity (tactile stimulus)
Time frame: 1 week
Pain due to dentin hypersensitivity (tactile stimulus)
Time frame: 2 weeks
Pain due to dentin hypersensitivity (tactile stimulus)
Time frame: 3 weeks
Pain due to dentin hypersensitivity (tactile stimulus)
Time frame: 4 weeks
Pain due to dentin hypersensitivity (tactile stimulus)
Time frame: 6 months
Pain due to dentin hypersensitivity (tactile stimulus)
Time frame: 12 months
Pain due to dentin hypersensitivity (thermal stimulus)
Time frame: 2 minutes after treatment
Pain due to dentin hypersensitivity (thermal stimulus)
Time frame: 1 week
Pain due to dentin hypersensitivity (thermal stimulus)
Time frame: 2 weeks
Pain due to dentin hypersensitivity (thermal stimulus)
Time frame: 3 weeks
Pain due to dentin hypersensitivity (thermal stimulus)
Time frame: 4 weeks
Pain due to dentin hypersensitivity (thermal stimulus)
Time frame: 6 months
Pain due to dentin hypersensitivity (thermal stimulus)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Hypersensitivity Dentin
Not yet recruiting
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations
Dental Restoration Failure, Postoperative Hypersensitivity
Recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
Dentin Sensitivity
Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Recruiting
Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
Dentine Hypersensitivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dina E Mohamed, Master principal investigator
Assistant lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sylc and fluoride varnish (Bifluorid 10) in people with Hypersensitivity Dentin and Tooth Hypersensitivity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain due to dentin hypersensitivity (evaporative stimulus) (time frame: 2 minutes after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.