Dentin SensitivityNCT02919202
Clinical Trial to Compare the Efficacy of a Fluoride Gel and a Dental Bonding Agent in Treatment of Tooth Sensitivity
A study testing Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride. and Self-etching Dentine Bonding Agent in people with Dentin Sensitivity, run by University of Kent at 1 site in United Kingdom.
Trial summary
This study compares the efficacy of two dental interventions in the treatment of cervical dentine sensitivity. The participants will be selected from adult dental patients registered at a general dental practice in West Sussex, UK. The participants will be split into 2 groups. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride. and Self-etching Dentine Bonding Agent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Oct 2016to 4 Jan 2017
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-60.
- Exhibiting CDS elicited by the two test stimuli in relation at least one tooth.
Who cannot join
- Patients who have undergone comprehensive periodontal treatment in the past 3 months.
- Patients under the age of 18 or unable to provide valid consent.
- Teeth that have visible fracture lines, caries, crowns or have been endodontically treated.
- Patients taking analgesic medication for any systemic conditions.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Carfax Dental Practice
Horsham, West Sussex, RH12 1EB
About this study
Official title: A Randomised Controlled Trial Investigating a Comparison of Fluoride Varnish vs Self-Etching Dentine Bonding Agent in the Reduction of Cervical Dentine Sensitivity in Patients Attending a General Dental Practice in West Sussex, UK.
This study compares the efficacy of two dental interventions in the treatment of cervical dentine sensitivity. The participants will be selected from adult dental patients registered at a general dental practice in West Sussex, UK. The participants will be split into 2 groups. One group will receive the intervention of topical fluoride varnish application while the other group will receive a topical application of self-etching dentine bonding agent.
Read the detailed description
Topical Fluoride Varnish(TFV) and Self-Etching Dentine Bonding Agent (SEDBA) are both routinely used in dentistry in the management of cervical dentine sensitivity(CDS). Both interventions are topically applied and well tolerated by patients. The interventions differ in mechanism of action. TFV releases fluoride which is incorporated into the organic matrix of dentine making the dentine tubules less conductive. Dentinal tubules form the key conduit between stimulus and pain perception in the tooth. SEDBA differs in that it penetrates and occludes the tubules. It is light cured for an almost instant set time.
- Conditions
- Dentin Sensitivity
- Being tested
- Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride., Self-etching Dentine Bonding Agent
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.Procedure or surgery
Also called Duraphat Varnish
Topical application to exposed dentine on one occasion.
Self-etching Dentine Bonding AgentProcedure or surgery
Also called Scotchbond Universal
Topical application to exposed dentine on one occasion followed by light-curing procedure.
| Study group | Role | What they receive |
|---|---|---|
| Fluoride Varnish | Experimental | Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride. Receives: Procedure: Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride. |
| SEDBA | Active comparator | Self-etching Dentine Bonding Agent. Scotchbond Universal by 3M ESPE. Topical application followed by light curing for 20 seconds. Receives: Procedure: Self-etching Dentine Bonding Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
to measure pain/sensitivity perception
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start26 Oct 2016
- Primary completion4 Jan 2017
- Study completion4 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin SensitivityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Parkin, PhD, Principal investigator, University of Kent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919202
- Sponsor's protocol ID
- ResGov 354
- Status last verified
- May 2017
- First submitted
- 27 Sep 2016
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Investigating a Comparison of Fluoride Varnish vs Self-Etching Dentine Bonding Agent in the Reduction of Cervical Dentine Sensitivity in Patients Attending a General Dental Practice in West Sussex, UK.
- ClinicalTrials.gov ID
- NCT02919202
- Acronym / sponsor ID
- ResGov 354
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of KentUniversity, hospital or other
- Study start
- 26 Oct 2016 (actual)
- Primary completion
- 4 Jan 2017 (actual)
- Study completion
- 4 Jan 2017 (actual)
- First posted
- 29 Sep 2016 (estimated)
- 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.
This study compares the efficacy of two dental interventions in the treatment of cervical dentine sensitivity. The participants will be selected from adult dental patients registered at a general dental practice in West Sussex, UK. The participants will be split into 2 groups. One group will receive the intervention of topical fluoride varnish application while the other group will receive a topical application of self-etching dentine bonding agent.
Detailed description
Topical Fluoride Varnish(TFV) and Self-Etching Dentine Bonding Agent (SEDBA) are both routinely used in dentistry in the management of cervical dentine sensitivity(CDS). Both interventions are topically applied and well tolerated by patients. The interventions differ in mechanism of action. TFV releases fluoride which is incorporated into the organic matrix of dentine making the dentine tubules less conductive. Dentinal tubules form the key conduit between stimulus and pain perception in the tooth. SEDBA differs in that it penetrates and occludes the tubules. It is light cured for an almost instant set time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoride Varnish | Experimental | Procedure: Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride. |
| SEDBA | Active comparator | Procedure: Self-etching Dentine Bonding AgentSelf-etching Dentine Bonding Agent. Scotchbond Universal by 3M ESPE. Topical application followed by light curing for 20 seconds. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18-60.
- Exhibiting CDS elicited by the two test stimuli in relation at least one tooth.
Key exclusion criteria (4 listed)
- Patients who have undergone comprehensive periodontal treatment in the past 3 months.
- Patients under the age of 18 or unable to provide valid consent.
- Teeth that have visible fracture lines, caries, crowns or have been endodontically treated.
- Patients taking analgesic medication for any systemic conditions.
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 |
|---|---|---|
| Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.Also: Duraphat VarnishTopical application to exposed dentine on one occasion. | Procedure or surgery | Fluoride Varnish |
| Self-etching Dentine Bonding AgentAlso: Scotchbond UniversalTopical application to exposed dentine on one occasion followed by light-curing procedure. | Procedure or surgery | SEDBA |
Primary outcome
Visual Analogue Scale
Time frame: 14 days
to measure pain/sensitivity perception
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 5 May 2017.
- Individual participant dataSharing planned: No
Related trials for Dentin Sensitivity
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.
Claire Parkin, PhD principal investigator
University of Kent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride. and Self-etching Dentine Bonding Agent in people with Dentin Sensitivity, run by University of Kent at 1 site in United Kingdom.
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 2 inclusion and 4 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 5 May 2017. 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 United Kingdom. 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?
Visual Analogue Scale (time frame: 14 days). 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 5 May 2017.