Dentin HypersensitivityPhase 2/3NCT04484844
Clinical Evaluation of Efficacy of Shield Force Plus Varnish VS Sodium Fluoride on Dentin Hypersensitivity
A Phase 2/3 study testing TOKUYAMA SHIELD FORCE PLUS and Sodium Fluoride 5% Dental Varnish in people with Dentin Hypersensitivity and Dentin Desensitizing Agents, run by Cairo University.
Trial summary
The aim of the study to compare the clinical effectiveness of Shield Force Plus (SFP) versus sodium fluoride varnish in the management of hypersensitivity of cervical dentin in adult patients for 8weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity, Dentin Desensitizing Agents
- What is being tested?
- TOKUYAMA SHIELD FORCE PLUS and Sodium Fluoride 5% Dental Varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Jan 2021
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with good oral hygiene.
- The age range of 18-65 years.
- Patients from both gender.
- Patients suffering from pain due to dentin hypersensitivity.
- Patients with sound first upper molars.
Who cannot join
- Patients with teeth exhibiting mobility (grade 2 or 3).
- Patients with constant use of analgesic, carious lesions, fractured teeth, defective restorations or prosthesis.
- Patients with orthodontics appliance.
- Patients with allergy sufferers with any of the materials will be used in the study as shield force plus and sodium fluoride.
- Patients with carious, crowned upper first molars.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Evaluation of Efficacy of Shield Force Plus Varnish Versus Sodium Fluoride on Cervical Dentin Hypersensitivity on Adult Patients: A Randomized Clinical Trial
The aim of the study to compare the clinical effectiveness of Shield Force Plus (SFP) versus sodium fluoride varnish in the management of hypersensitivity of cervical dentin in adult patients for 8weeks.
- Being tested
- TOKUYAMA SHIELD FORCE PLUS, Sodium Fluoride 5% Dental Varnish
- Keywords
- Dentin hypersensitivity, Dentin sensitivity, Shield force plus, Dentin Desensitizing Agents, sodium fluoride varnish
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOKUYAMA SHIELD FORCE PLUSDrug
Self-reinforcing (SR) monomer technology
Sodium Fluoride 5% Dental VarnishDrug
5% NaF
| Study group | Role | What they receive |
|---|---|---|
| Shield Force Plus Varnish | Experimental | Shield force plus (SFP), Self-reinforcing (SR) monomer technology supplied in the form of one component self-etching light-cured dental adhesive, which is characterized by an SR monomer component that penetrates the tooth substrate. Multi-point interactions with apatite calcium and three-dimensional cross-linking occur reactions.it forms a thin even, hard coating on the tooth surface that gives the tooth substrate a superior binding power. Receives: Drug: TOKUYAMA SHIELD FORCE PLUS |
| Sodium Fluoride varnish | Active comparator | Topical application of varnish fluoride (sodium fluoride NaF) effect on exposed dentine as a desensitizing agent, the varnish fluoride process is caused by the reaction between NaF and calcium ions resulting in calcium fluoride crystals being deposited on the openings of the dentinal tubules that decrease pain. Receives: Drug: Sodium Fluoride 5% Dental Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentin Hypersensitivity
measurement of dentin hypersensitivity by VAS Scale
Measured: Pre-intervention
Dentin Hypersensitivity
measurement of dentin hypersensitivity by VAS Scale
Measured: 2 min
Dentin Hypersensitivity
measurement of dentin hypersensitivity by VAS Scale
Measured: 1 week
Dentin Hypersensitivity
measurement of dentin hypersensitivity by VAS Scale
Measured: 4 weeks
Dentin Hypersensitivity
measurement of dentin hypersensitivity by VAS Scale
Measured: 8 weeks
Secondary outcomes (2)
Dentinal Tubule Occlusion
percentage of dentinal tubule occlusion measure by scanning electron microscope SEM
Measured: Pre-intervention
Dentinal Tubule Occlusion
percentage of dentinal tubule occlusion measure by scanning electron microscope SEM
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study startOct 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin HypersensitivityStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feras Mustafa Fares Salem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484844
- Sponsor's protocol ID
- OPER 20/7/2020
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Efficacy of Shield Force Plus Varnish Versus Sodium Fluoride on Cervical Dentin Hypersensitivity on Adult Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04484844
- Acronym / sponsor ID
- OPER 20/7/2020
- Keywords
- Dentin hypersensitivity, Dentin sensitivity, Shield force plus, Dentin Desensitizing Agents, sodium fluoride varnish
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 24 Jul 2020 (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.
The aim of the study to compare the clinical effectiveness of Shield Force Plus (SFP) versus sodium fluoride varnish in the management of hypersensitivity of cervical dentin in adult patients for 8weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shield Force Plus Varnish | Experimental | Drug: TOKUYAMA SHIELD FORCE PLUSShield force plus (SFP), Self-reinforcing (SR) monomer technology supplied in the form of one component self-etching light-cured dental adhesive, which is characterized by an SR monomer component that penetrates the tooth substrate. Multi-point interactions with apatite calcium and three-dimensional cross-linking occur reactions.it forms a thin even, hard coating on the tooth surface that gives the tooth substrate a superior binding power. |
| Sodium Fluoride varnish | Active comparator | Drug: Sodium Fluoride 5% Dental VarnishTopical application of varnish fluoride (sodium fluoride NaF) effect on exposed dentine as a desensitizing agent, the varnish fluoride process is caused by the reaction between NaF and calcium ions resulting in calcium fluoride crystals being deposited on the openings of the dentinal tubules that decrease pain. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with good oral hygiene.
- The age range of 18-65 years.
- Patients from both gender.
- Patients suffering from pain due to dentin hypersensitivity.
- Patients with sound first upper molars.
Key exclusion criteria (5 listed)
- Patients with teeth exhibiting mobility (grade 2 or 3).
- Patients with constant use of analgesic, carious lesions, fractured teeth, defective restorations or prosthesis.
- Patients with orthodontics appliance.
- Patients with allergy sufferers with any of the materials will be used in the study as shield force plus and sodium fluoride.
- Patients with carious, crowned upper first molars.
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 |
|---|---|---|
| TOKUYAMA SHIELD FORCE PLUSSelf-reinforcing (SR) monomer technology | Drug | Shield Force Plus Varnish |
| Sodium Fluoride 5% Dental Varnish5% NaF | Drug | Sodium Fluoride varnish |
Primary outcome
Dentin Hypersensitivity
Time frame: Pre-intervention
measurement of dentin hypersensitivity by VAS Scale
Dentin Hypersensitivity
Time frame: 2 min
measurement of dentin hypersensitivity by VAS Scale
Dentin Hypersensitivity
Time frame: 1 week
measurement of dentin hypersensitivity by VAS Scale
Dentin Hypersensitivity
Time frame: 4 weeks
measurement of dentin hypersensitivity by VAS Scale
Dentin Hypersensitivity
Time frame: 8 weeks
measurement of dentin hypersensitivity by VAS Scale
2 secondary outcomes
Dentinal Tubule Occlusion
Time frame: Pre-intervention
Dentinal Tubule Occlusion
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TOKUYAMA SHIELD FORCE PLUS and Sodium Fluoride 5% Dental Varnish in people with Dentin Hypersensitivity and Dentin Desensitizing Agents, run by Cairo University.
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 5 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: status not confirmed, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feras Mustafa Salem, BSc (00201008471183, feras.fares@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentin Hypersensitivity (time frame: Pre-intervention). The study lists 5 primary outcomes in all. 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 24 Jul 2020.