Dentin HypersensitivityNCT03851900
A Comparison of Long-Term Effectiveness of Two Desensitizing Products
A study testing Teethmate Desensitizer (TM), Clearfil SE Bond 2 and Distilled water in people with Dentin Hypersensitivity, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
This randomized, controlled, clinical trial aimed to compare the 6- month clinical performance of a desensitizer that contains calcium phosphate TM with a two-step self-etch adhesive SE and placebo (distilled water). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Teethmate Desensitizer (TM), Clearfil SE Bond 2 and Distilled water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 1 Oct 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with 3 or more hypersensitive teeth with a VAS (Visual Analog Scale) score
- Willingness to participate in the study
Who cannot join
- Subjects are unwilling to participate voluntarily
- Patients under 18 years old
- Those that were taking analgesic medicaments
- Pregnant and breastfeeding females
- The presence of a systemic disease that affects the participation
- Teeth with cervical loss of hard tissue that need restoration absolutely
Show all 9Show fewer
- Large/defective restoration, caries or enamel cracks in sensitive teeth
- Teeth with vulnerability to hypersensitivity after root scaling
- Pulpitis presence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Long-Term Effectiveness of Two Desensitizing Products: A Randomized Clinical Placebo-Controlled Study
This randomized, controlled, clinical trial aimed to compare the 6- month clinical performance of a desensitizer that contains calcium phosphate TM with a two-step self-etch adhesive SE and placebo (distilled water). At least 150 teeth wil be treated with desensitizing products and placebo randomly one third usig TM, one third using SE and one third using placebo. The efficiency of the materials will be evaluated at baseline, 1 week, 1 month, 3 months and 6 months after treatment.
Read the detailed description
The aim of this randomized, controlled, clinical trial is to compare the clinical efficacy of a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo through a long-term period (6 months). At least fifty patients with a sensitivity score of 6 or higher, according to the Visual Analog Scale (VAS), with at least three teeth will participate in this study. Teethmate Desensitizer (TM), Clearfil SE Bond 2 (SE) and placebo (distilled water) will be applied randomly to three teeth of each patient. Recalls will be done at baseline, 1 week, 1 month, 3 months and 6 months after treatment by applying air-blast and the sensitivity scores will be determined according to VAS. The efficiency of the materials will be determined according to the VAS scores. Data will be analyzed using Paired t test and repeated measures of ANOVA.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Teethmate Desensitizer (TM), Clearfil SE Bond 2, Distilled water
- Keywords
- Dentin hypersensitivity, Randomized clinical trial, Calcium phosphate desensitizer, Adhesive resin, VAS
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teethmate Desensitizer (TM)Other
Desensitizing agent will be applied to sensitive teeth.
Clearfil SE Bond 2Other
Desensitizing agent will be applied to sensitive teeth.
Distilled waterOther
Placebo will be applied to sensitive teeth as a negative control.
| Study group | Role | What they receive |
|---|---|---|
| Teethmate Desensitizer (TM) | Experimental | Calcium phosphate biomimetic material that forms hydroxyapatite from tetracalcium phosphate and dicalcium phosphate anhydrous and plug the dentin tubules causing remineralization and dentin hypersensitivity relief. Receives: Other: Teethmate Desensitizer (TM) |
| Clearfil SE Bond 2 (SE) | Active comparator | Two-step self etch adhesive resin treating dentin hypersensitivity b covering a film layer after light-curing. Receives: Other: Clearfil SE Bond 2 |
| Distilled water | Placebo comparator | Distilled water with no desensitizing components. Receives: Other: Distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of desensitizers through long-term period
The clinical efficacy of a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo through a long-term period. Evaluation will be performed usig the Visual Analog Scale(VAS). VAS values will be according to the following parameters: 0 - no discomfort;1 to 3 - light discomfort;4 to 6 - mild discomfort;7 to 9 - severe discomfort;10 - Unbearable discomfort. After each stimulus to the suspected site the degree of hypersensitivity will be determined from 6 to 10 as the preop VAS score for each individual painful tooth.
Measured: 6 months
Secondary outcomes (1)
Subjective satisfaction of patients
Because of the patient-centered aspect of the study patients' subjective satisfaction will be prior. Patients will be asked to define their sensitivity according to Visual Analog Scale (VAS) scale. VAS values will be according to the following parameters:
0 - no discomfort;1 to 3 - light discomfort;4 to 6 - mild discomfort;7 to 9 - severe discomfort;10 - Unbearable discomfort. In case of persistant or recurrent sensitivity reported by the participants after application of desensitizing agents or placebo, even if the Visual Analog Scale score was decreased, it was accepted as failure, so alternative hypersensitivity treatments applied and current teeth will be excluded.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 Feb 2019
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- For each patient, selected teeth will be randomly assigned to TM, SE or placebo by the lottery method. The subjects will blind to the agent being used. All applications will be performed by the same examiner.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Leyla Kerimova, Baskent University
- Investigators
- Arlin Kiremitci, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851900
- Sponsor's protocol ID
- Hacettepe 2017/06-26 KA-16009
- Status last verified
- Oct 2019
- First submitted
- 21 Feb 2019
- Last updated
- 3 Oct 2019
- 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 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Long-Term Effectiveness of Two Desensitizing Products: A Randomized Clinical Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT03851900
- Acronym / sponsor ID
- Hacettepe 2017/06-26 KA-16009
- Conditions
- Dentin Hypersensitivity
- Keywords
- Dentin hypersensitivity, Randomized clinical trial, Calcium phosphate desensitizer, Adhesive resin, VAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 22 Feb 2019 (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.
This randomized, controlled, clinical trial aimed to compare the 6- month clinical performance of a desensitizer that contains calcium phosphate TM with a two-step self-etch adhesive SE and placebo (distilled water). At least 150 teeth wil be treated with desensitizing products and placebo randomly one third usig TM, one third using SE and one third using placebo. The efficiency of the materials will be evaluated at baseline, 1 week, 1 month, 3 months and 6 months after treatment.
Detailed description
The aim of this randomized, controlled, clinical trial is to compare the clinical efficacy of a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo through a long-term period (6 months). At least fifty patients with a sensitivity score of 6 or higher, according to the Visual Analog Scale (VAS), with at least three teeth will participate in this study. Teethmate Desensitizer (TM), Clearfil SE Bond 2 (SE) and placebo (distilled water) will be applied randomly to three teeth of each patient. Recalls will be done at baseline, 1 week, 1 month, 3 months and 6 months after treatment by applying air-blast and the sensitivity scores will be determined according to VAS. The efficiency of the materials will be determined according to the VAS scores. Data will be analyzed using Paired t test and repeated measures of ANOVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- For each patient, selected teeth will be randomly assigned to TM, SE or placebo by the lottery method. The subjects will blind to the agent being used. All applications will be performed by the same examiner.
| Arm | Type | Receives |
|---|---|---|
| Teethmate Desensitizer (TM) | Experimental | Other: Teethmate Desensitizer (TM)Calcium phosphate biomimetic material that forms hydroxyapatite from tetracalcium phosphate and dicalcium phosphate anhydrous and plug the dentin tubules causing remineralization and dentin hypersensitivity relief. |
| Clearfil SE Bond 2 (SE) | Active comparator | Other: Clearfil SE Bond 2Two-step self etch adhesive resin treating dentin hypersensitivity b covering a film layer after light-curing. |
| Distilled water | Placebo comparator | Other: Distilled waterDistilled water with no desensitizing components. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with 3 or more hypersensitive teeth with a VAS (Visual Analog Scale) score
- Willingness to participate in the study
Key exclusion criteria (9 listed)
- Subjects are unwilling to participate voluntarily
- Patients under 18 years old
- Those that were taking analgesic medicaments
- Pregnant and breastfeeding females
- The presence of a systemic disease that affects the participation
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 |
|---|---|---|
| Teethmate Desensitizer (TM)Desensitizing agent will be applied to sensitive teeth. | Other | Teethmate Desensitizer (TM) |
| Clearfil SE Bond 2Desensitizing agent will be applied to sensitive teeth. | Other | Clearfil SE Bond 2 (SE) |
| Distilled waterPlacebo will be applied to sensitive teeth as a negative control. | Other | Distilled water |
Primary outcome
The effectiveness of desensitizers through long-term period
Time frame: 6 months
The clinical efficacy of a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo through a long-term period. Evaluation will be performed usig the Visual Analog Scale(VAS). VAS values will be according to the following parameters: 0 - no discomfort;1 to 3 - light discomfort;4 to 6 - mild discomfort;7 to 9 - severe discomfort;10 - Unbearable discomfort. After each stimulus to the suspected site the degree of hypersensitivity will be determined from 6 to 10 as the preop VAS score for each individual painful tooth.
1 secondary outcome
Subjective satisfaction of patients
Time frame: 6 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 3 Oct 2019.
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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.
Arlin Kiremitci study director
Hacettepe 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 Teethmate Desensitizer (TM), Clearfil SE Bond 2 and Distilled water in people with Dentin Hypersensitivity, run by Baskent University at 1 site in Turkey (Türkiye).
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 9 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 3 Oct 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
The effectiveness of desensitizers through long-term period (time frame: 6 months). 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 3 Oct 2019.