Dentin HypersensitivityNCT04527159
Comparison of Desensitizing Materials
A study testing Fluoraphat Pro / VivaSens in people with Dentin Hypersensitivity, run by Nourah Mulfi Aljasser at 1 site in Saudi Arabia.
Trial summary
To compare the efficacy of two commercially available in-office desensitizing agents (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Fluoraphat Pro / VivaSens
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 6 Jan 2019to 24 Feb 2020
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females aged between 18 and 50 years
- Patient should have at least 2 teeth with dentinal hypersensitivity
- Sound tooth structure
- Willingness to participate in the study
Who cannot join
- Gingival recession
- Caries
- Non-carious lesions (attrition, abrasion, erosion, abfraction)
- Teeth restored with dental filling
- Fractured or cracked tooth
- Microleakage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Two Different Desensitizing Materials in Controlling Natural Dentin Hypersensitivity: A Randomized Controlled Clinical Trial
To compare the efficacy of two commercially available in-office desensitizing agents (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity.
Read the detailed description
Dentine hypersensitivity (DH) is a condition that occurs in non-pathological, non-defective teeth and is defined as "a short, sharp pain in response to stimuli, typically thermal, evaporative, tactile, osmotic or chemical and which cannot be attributed to any other dental defect or pathology". The incidence of DH ranges from 4% to 74% in several studies. Mandibular first molars, canines and premolars of both jaws are most commonly affected by DH.
The pathogenesis of DH is linked to exposure of dentinal tubules that can occur in the oral cavity due to dental erosion from acidogenic diets, aggressive tooth-brushing, injudicious use of whitening products, gingival recession, periodontal debridement or surgery. The most commonly reported initiating factor is cold drinks. Management usually involves methods that can achieve one or both of the following objectives; i) alteration of fluid flow in the dentinal tubules and ii) modification or blocking of the pulpal nerve response.
A broad range of products that achieve these objectives have been developed after rigorous trials and can be used in-office or at home depending on the severity of the condition. These products are commonly referred to as desensitizing agents. Grossman suggested that an ideal desensitizing agent should be non-irritating to the pulp, relatively painless on application, easy to apply, rapid in action, effective for long periods of time and should not stain the teeth.
The use of dentine desensitizers has become one of the most common methods in managing DH. The most commonly used desensitizers contain components such as fluoride, triclosan, benzalkonium chloride, ethylene diaminetetraacetic acid and glutaraldehyde. Fluoraphat Pro (Neumunster, Germany) and VivaSens® (Ivoclar Vivadent, Schaan, Liechtenstein, Switzerland) are two agents that have been tested for use as dentine desensitizers and are currently available for commercial use. In the present study, two such varnishes VivaSens (Ivoclar Vivadent, Schaan, Liechtenstein, and Switzerland) and Fluoraphat (Promedical Neumunster, Germany) have been used. The present study aims to establish which of the two desensitizing agents has better efficacy in reducing hypersensitivity in patients who have been previously diagnosed with DH.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Fluoraphat Pro / VivaSens
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoraphat Pro / VivaSensDrug
Also called VivaSens
desensitizing agents for treatment of dentinal hypersensitivity
| Study group | Role | What they receive |
|---|---|---|
| desensitizing agents (Fluoraphat Pro and VivaSens®) | Other | 22 participants above the age of 18 years who presented to dental clinics in Riyadh Elm University with dentine hypersensitivity were randomly selected to participate in the study.
Each participant has at least two teeth with natural hypersensitivity which was not caused by any iatrogenic causes or bad oral habits, so there are 44 cases divided into two groups according to the material used, each group has 22 teeth, that make it applicable to apply the studied material with every patient on individual tooth with the same variables of the oral mouth. When teeth in the hypersensitivity group were evaluated for the level of DH, all teeth were found to have Grade 4 sensitivity. Receives: Drug: Fluoraphat Pro / VivaSens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likert type scale used to measure attitudes or opinions
Likert type scale grading from 0-4 0: No sensitivity
- Very mild sensitivity
- Mild sensitivity
- Moderate Sensitivity
- Severe Sensitivity to compare the efficacy of two commercially available in-office desensitizing agents (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity.
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start6 Jan 2019
- Primary completion30 Mar 2019
- Study completion24 Feb 2020
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourah Mulfi Aljasser
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nourah Mulfi Aljasser, Riyadh Elm University
- Investigators
- Roula Alboouni, Prof, Study director, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527159
- Sponsor's protocol ID
- dentin hypersensitivity
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Different Desensitizing Materials in Controlling Natural Dentin Hypersensitivity: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04527159
- Acronym / sponsor ID
- dentin hypersensitivity
- Conditions
- Dentin Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Nourah Mulfi AljasserUniversity, hospital or other
- Study start
- 6 Jan 2019 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 26 Aug 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.
To compare the efficacy of two commercially available in-office desensitizing agents (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity.
Detailed description
Dentine hypersensitivity (DH) is a condition that occurs in non-pathological, non-defective teeth and is defined as "a short, sharp pain in response to stimuli, typically thermal, evaporative, tactile, osmotic or chemical and which cannot be attributed to any other dental defect or pathology". The incidence of DH ranges from 4% to 74% in several studies. Mandibular first molars, canines and premolars of both jaws are most commonly affected by DH.
The pathogenesis of DH is linked to exposure of dentinal tubules that can occur in the oral cavity due to dental erosion from acidogenic diets, aggressive tooth-brushing, injudicious use of whitening products, gingival recession, periodontal debridement or surgery. The most commonly reported initiating factor is cold drinks. Management usually involves methods that can achieve one or both of the following objectives; i) alteration of fluid flow in the dentinal tubules and ii) modification or blocking of the pulpal nerve response.
A broad range of products that achieve these objectives have been developed after rigorous trials and can be used in-office or at home depending on the severity of the condition. These products are commonly referred to as desensitizing agents. Grossman suggested that an ideal desensitizing agent should be non-irritating to the pulp, relatively painless on application, easy to apply, rapid in action, effective for long periods of time and should not stain the teeth.
The use of dentine desensitizers has become one of the most common methods in managing DH. The most commonly used desensitizers contain components such as fluoride, triclosan, benzalkonium chloride, ethylene diaminetetraacetic acid and glutaraldehyde. Fluoraphat Pro (Neumunster, Germany) and VivaSens® (Ivoclar Vivadent, Schaan, Liechtenstein, Switzerland) are two agents that have been tested for use as dentine desensitizers and are currently available for commercial use. In the present study, two such varnishes VivaSens (Ivoclar Vivadent, Schaan, Liechtenstein, and Switzerland) and Fluoraphat (Promedical Neumunster, Germany) have been used. The present study aims to establish which of the two desensitizing agents has better efficacy in reducing hypersensitivity in patients who have been previously diagnosed with DH.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| desensitizing agents (Fluoraphat Pro and VivaSens®) | Other | Drug: Fluoraphat Pro / VivaSens22 participants above the age of 18 years who presented to dental clinics in Riyadh Elm University with dentine hypersensitivity were randomly selected to participate in the study. Each participant has at least two teeth with natural hypersensitivity which was not caused by any iatrogenic causes or bad oral habits, so there are 44 cases divided into two groups according to the material used, each group has 22 teeth, that make it applicable to apply the studied material with every patient on individual tooth with the same variables of the oral mouth. When teeth in the hypersensitivity group were evaluated for the level of DH, all teeth were found to have Grade 4 sensitivity. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females aged between 18 and 50 years
- Patient should have at least 2 teeth with dentinal hypersensitivity
- Sound tooth structure
- Willingness to participate in the study
Key exclusion criteria (6 listed)
- Gingival recession
- Caries
- Non-carious lesions (attrition, abrasion, erosion, abfraction)
- Teeth restored with dental filling
- Fractured or cracked tooth
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 |
|---|---|---|
| Fluoraphat Pro / VivaSensAlso: VivaSensdesensitizing agents for treatment of dentinal hypersensitivity | Drug | desensitizing agents (Fluoraphat Pro and VivaSens®) |
Primary outcome
Likert type scale used to measure attitudes or opinions
Time frame: 24 Hours
Likert type scale grading from 0-4 0: No sensitivity 1. Very mild sensitivity 2. Mild sensitivity 3. Moderate Sensitivity 4. Severe Sensitivity to compare the efficacy of two commercially available in-office desensitizing agents (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity.
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 1 Sep 2020.
Related trials for Dentin Hypersensitivity
Not yet 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
Not yet recruiting
A Clinical Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
Dentin Sensitivity
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.
Roula Alboouni, Prof study director
Riyadh Elm University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoraphat Pro / VivaSens in people with Dentin Hypersensitivity, run by Nourah Mulfi Aljasser at 1 site in Saudi Arabia.
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 6 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 1 Sep 2020. 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 Saudi Arabia. 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.
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?
Likert type scale used to measure attitudes or opinions (time frame: 24 Hours). 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 1 Sep 2020.