Dentin HypersensitivityPhase 3NCT04591444
Fluoride Varnish X Glass Ionomer Sealant on Cervical Dentin Hypersensitivity
A Phase 3 study testing Fluoride Varnish and Glass Ionomer Sealant in people with Dentin Hypersensitivity and Dentin Sensitivity, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Dentin hypersensitivity (DH) can be defined as acute, short-duration pain from open dentin tubules in exposed dentin. The symptom of DH is subjective and varies from patient to patient and may present as mild discomfort or as a high-intensity pain, which can affect the individual's quality of life, interfering with… 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, Dentin Sensitivity
- What is being tested?
- Fluoride Varnish and Glass Ionomer Sealant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2017to Mar 2020
- Phase
- Phase 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum age of 18 years old;
- Presented good general health;
- Presented at least one tooth with DH reported in the cervical region, which has a graded sensitivity of 4 or more on the VAS scale.
Who cannot join
- Presented active caries lesions or with defective restorations in the tooth to be analyzed;
- Presented enough dentin loss that required restorative treatment or periodontal surgery;
- Volunteers who underwent any professional desensitizing treatment in the last 6 months;
- Volunteers who used desensitizing pastes in the 3 months;
- Volunteers who were using anti-inflammatory or analgesic drugs at the time of recruitment;
- Volunteers were are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Fluoride Varnish and a Glass Ionomer Sealant on Cervical Dentin Hypersensitivity: A Randomized Clinical Trial
Dentin hypersensitivity (DH) can be defined as acute, short-duration pain from open dentin tubules in exposed dentin. The symptom of DH is subjective and varies from patient to patient and may present as mild discomfort or as a high-intensity pain, which can affect the individual's quality of life, interfering with their eating and hygiene habits. One approach to treatment would be the use of agents that chemically desensitize sensory nerves, blocking the transmission of nerve stimuli to the central nervous system.
The effectiveness of desensitizing treatments is influenced by several factors present in the oral cavity, which can contribute to a greater effect of these agents but can also be responsible for removing them from the dental surface. To date, studies have been carried out in the short term, not exceeding an average period of 12 weeks, so there is no consensus on the technique or agent that will guarantee the most effective and lasting effect against DH, not even the ideal period for reapplication. Thus, more studies are needed to assess the clinical behavior of desensitizing products on the market, especially the most recent releases. Therefore, the aim of this study was to clinically compare the effectiveness of different office treatments for DH, being ClinproTM White Varnish, ClinproTM XT Varnish, and a control group (placebo) through pain assessment with the Visual Analog Scale (VAS), after stimulation with air from the triple syringe.
Read the detailed description
This study compares the effectiveness of two in-office treatment for dentin hypersensitivity: G1:ClinproTM White Varnish, G2:ClinproTM XT Varnish, and a G3:placebo (where the application of a product was only simulated). Recruitment of the 121 volunteers were based on their self-reported complaint of dentin hypersensitivity, which confirmed with the use of an air blast from a triple syringe. Then, he/she showed in the VAS scale (which varies from 0=no pain to 10=the worst pain possible) the value that best describes the pain sensation. The subjects that present at least one tooth with a value of 4 and above in the VAS scale (if more than one hypersensitive tooth was present, the mean VAS values obtained were used, for each patient) was randomly allocated into the experimental groups. Two weeks before the study started, the volunteers went through a wash out period, where they used only the oral hygiene products donated by the researchers, which were used up to the end of the study. The in-office treatments were performed after prophylaxis, according to the manufacturer´s instructions, by one trained researcher, which was blind to the treatments. DH evaluation was performed 15 min after the application of the treatments, by a different researcher, which also blind to the treatment, and which used the same methodology described early for the detection of initial pain. The volunteers were recalled for the DH evaluation after one and four weeks of the treatments. DH evaluation was also performed after 12 and 24 weeks of the treatments, except in the placebo group, which received the proper DH treatment after the first four weeks of the study. Data was analyzed with the appropriate statistical methods (α=0.05).
- Conditions
- Dentin Hypersensitivity, Dentin Sensitivity
- Being tested
- Fluoride Varnish, Glass Ionomer Sealant, Placebo Group
- Keywords
- Dentin hypersensitivity, Dentin sensitivity, Hypersensitivity, Fluorides, Sodium fluoride, Glass ionomer sealant, Desensitizing treatment, Glass ionomer cement
- 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.
Fluoride VarnishDrug
Also called ClinproTM White Varnish
Following the manufacturer's recommendations, it was not necessary to moisten or dry the treated surface beforehand or afterwards. The product was dispensed and manipulated for 15 s until a homogeneous mixture was obtained, applied with a micro brush, flowing into interproximal areas, and quickly adhering to the tooth surface in the presence of saliva.
Glass Ionomer SealantDrug
Also called ClinproTM XT Varnish, Resin-modified Glass Ionomer Sealant
Following the manufacturer's recommendations, prophylaxis and prior drying of the treated surface was carried out, the product was also dispensed and manipulated for 15 s until a homogeneous mixture was obtained, applied with a micro brush and light-cured for 20 s.
Placebo GroupOther
4 weeks after the simulation of the treatment application, participants in the placebo group received DH treatment with the product that had the best effect in the first 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ClinproTM White Varnish | Active comparator | Application of ClinproTM White Varnish containing sodium fluoride (5%) and Tricalcium phosphate (TCP).
A technology that allows calcium and phosphate ions to coexist with fluoride ions separately, forming a more resistant mineral on the tooth surface (3M ESPE Clinpro White Varnish; 3M ESPE Clinpro 5000). Receives: Drug: Fluoride Varnish |
| ClinproTM XT Varnish | Active comparator | Application of ClinproTM XT Varnish, a resin-modified glass ionomer sealant.
Creates a protective layer on exposed dentin, which is durable and has the ability to release fluoride, calcium and phosphate into the surroundings. (3M ESPE Clinpro XT Varnish). Receives: Drug: Glass Ionomer Sealant |
| Placebo Group | Placebo comparator | Participants who were part of the placebo group continuously used only the conventional toothpaste provided in the oral hygiene kit during the initial four weeks of the research and received a simulated treatment. Receives: Other: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the dentin hypersensitivity
The evaluation was performed with the use of Visual Analog Scale (VAS). The volunteers pointed out on the VAS (ranging from 0=no pain to 10=worst possible pain) the whole number, which best described his perception of pain at the moment.
The primary outcome was the difference between the Visual Analog Scale values obtained in the baseline and 4 weeks after the treatment.
Measured: 4 weeks
Secondary outcomes (2)
Dentin hypersensitivity
This secondary outcome was the Visual Analog Scale (VAS) score related to dentin hypersensitivity. The volunteers pointed out on the VAS (ranging from 0=no pain to 10=worst possible pain) the whole number, which best described his perception of pain at the moment.
Visual Analog Scale was applied before the treatment (baseline), 15 minutes after the procedures, one week, and 4 weeks after treatments to measure the changes in dentin hypersensitivity.
Measured: baseline, 15 minutes after the treatments, 1 week and 4 weeks.
Change in the dentin hypersensitivity
The evaluation was performed with the use of Visual Analog Scale (VAS). The volunteers pointed out on the VAS (ranging from 0=no pain to 10=worst possible pain) the whole number, which best described his perception of pain at the moment.
This secondary outcome was the difference between the Visual Analog Scale values obtained in the baseline and 3 and 6 months after the treatment (Long-term differences in the VAS values).
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study startJan 2017
- Primary completionOct 2019
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentin HypersensitivityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study is a parallel, randomized, triple blind clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fausto Medeiros Mendes, University of Sao Paulo
- Investigators
- Taís Scaramucci Forlin, Assistant Professor, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591444
- Sponsor's protocol ID
- HDFOUSP
- Status last verified
- Oct 2020
- First submitted
- 11 Oct 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Machado AC, Maximiano V, Yoshida ML, Freitas JG, Mendes FM, Aranha ACC, Scaramucci T. Efficacy of a calcium-phosphate/fluoride varnish and ionomeric sealant on cervical dentin hypersensitivity: A randomized, double-blind, placebo-controlled clinical study. J Oral Rehabil. 2022 Jan;49(1):62-70. doi: 10.1111/joor.13270. Epub 2021 Nov 2.
PubMed 34676918
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Fluoride Varnish and a Glass Ionomer Sealant on Cervical Dentin Hypersensitivity: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04591444
- Acronym / sponsor ID
- HDFOUSP
- Conditions
- Dentin Hypersensitivity, Dentin Sensitivity
- Keywords
- Dentin hypersensitivity, Dentin sensitivity, Hypersensitivity, Fluorides, Sodium fluoride, Glass ionomer sealant, Desensitizing treatment, Glass ionomer cement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 19 Oct 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.
Dentin hypersensitivity (DH) can be defined as acute, short-duration pain from open dentin tubules in exposed dentin. The symptom of DH is subjective and varies from patient to patient and may present as mild discomfort or as a high-intensity pain, which can affect the individual's quality of life, interfering with their eating and hygiene habits. One approach to treatment would be the use of agents that chemically desensitize sensory nerves, blocking the transmission of nerve stimuli to the central nervous system.
The effectiveness of desensitizing treatments is influenced by several factors present in the oral cavity, which can contribute to a greater effect of these agents but can also be responsible for removing them from the dental surface. To date, studies have been carried out in the short term, not exceeding an average period of 12 weeks, so there is no consensus on the technique or agent that will guarantee the most effective and lasting effect against DH, not even the ideal period for reapplication. Thus, more studies are needed to assess the clinical behavior of desensitizing products on the market, especially the most recent releases. Therefore, the aim of this study was to clinically compare the effectiveness of different office treatments for DH, being ClinproTM White Varnish, ClinproTM XT Varnish, and a control group (placebo) through pain assessment with the Visual Analog Scale (VAS), after stimulation with air from the triple syringe.
Detailed description
This study compares the effectiveness of two in-office treatment for dentin hypersensitivity: G1:ClinproTM White Varnish, G2:ClinproTM XT Varnish, and a G3:placebo (where the application of a product was only simulated). Recruitment of the 121 volunteers were based on their self-reported complaint of dentin hypersensitivity, which confirmed with the use of an air blast from a triple syringe. Then, he/she showed in the VAS scale (which varies from 0=no pain to 10=the worst pain possible) the value that best describes the pain sensation. The subjects that present at least one tooth with a value of 4 and above in the VAS scale (if more than one hypersensitive tooth was present, the mean VAS values obtained were used, for each patient) was randomly allocated into the experimental groups. Two weeks before the study started, the volunteers went through a wash out period, where they used only the oral hygiene products donated by the researchers, which were used up to the end of the study. The in-office treatments were performed after prophylaxis, according to the manufacturer´s instructions, by one trained researcher, which was blind to the treatments. DH evaluation was performed 15 min after the application of the treatments, by a different researcher, which also blind to the treatment, and which used the same methodology described early for the detection of initial pain. The volunteers were recalled for the DH evaluation after one and four weeks of the treatments. DH evaluation was also performed after 12 and 24 weeks of the treatments, except in the placebo group, which received the proper DH treatment after the first four weeks of the study. Data was analyzed with the appropriate statistical methods (α=0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The present study is a parallel, randomized, triple blind clinical trial.
| Arm | Type | Receives |
|---|---|---|
| ClinproTM White Varnish | Active comparator | Drug: Fluoride VarnishApplication of ClinproTM White Varnish containing sodium fluoride (5%) and Tricalcium phosphate (TCP). A technology that allows calcium and phosphate ions to coexist with fluoride ions separately, forming a more resistant mineral on the tooth surface (3M ESPE Clinpro White Varnish; 3M ESPE Clinpro 5000). |
| ClinproTM XT Varnish | Active comparator | Drug: Glass Ionomer SealantApplication of ClinproTM XT Varnish, a resin-modified glass ionomer sealant. Creates a protective layer on exposed dentin, which is durable and has the ability to release fluoride, calcium and phosphate into the surroundings. (3M ESPE Clinpro XT Varnish). |
| Placebo Group | Placebo comparator | Other: Placebo GroupParticipants who were part of the placebo group continuously used only the conventional toothpaste provided in the oral hygiene kit during the initial four weeks of the research and received a simulated treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Minimum age of 18 years old;
- Presented good general health;
- Presented at least one tooth with DH reported in the cervical region, which has a graded sensitivity of 4 or more on the VAS scale.
Key exclusion criteria (6 listed)
- Presented active caries lesions or with defective restorations in the tooth to be analyzed;
- Presented enough dentin loss that required restorative treatment or periodontal surgery;
- Volunteers who underwent any professional desensitizing treatment in the last 6 months;
- Volunteers who used desensitizing pastes in the 3 months;
- Volunteers who were using anti-inflammatory or analgesic drugs at the time of recruitment;
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 |
|---|---|---|
| Fluoride VarnishAlso: ClinproTM White VarnishFollowing the manufacturer's recommendations, it was not necessary to moisten or dry the treated surface beforehand or afterwards. The product was dispensed and manipulated for 15 s until a homogeneous mixture was obtained, applied with a micro brush, flowing into interproximal areas, and quickly adhering to the tooth surface in the presence of saliva. | Drug | ClinproTM White Varnish |
| Glass Ionomer SealantAlso: ClinproTM XT Varnish, Resin-modified Glass Ionomer SealantFollowing the manufacturer's recommendations, prophylaxis and prior drying of the treated surface was carried out, the product was also dispensed and manipulated for 15 s until a homogeneous mixture was obtained, applied with a micro brush and light-cured for 20 s. | Drug | ClinproTM XT Varnish |
| Placebo Group4 weeks after the simulation of the treatment application, participants in the placebo group received DH treatment with the product that had the best effect in the first 4 weeks. | Other | Placebo Group |
Primary outcome
Change in the dentin hypersensitivity
Time frame: 4 weeks
The evaluation was performed with the use of Visual Analog Scale (VAS). The volunteers pointed out on the VAS (ranging from 0=no pain to 10=worst possible pain) the whole number, which best described his perception of pain at the moment. The primary outcome was the difference between the Visual Analog Scale values obtained in the baseline and 4 weeks after the treatment.
2 secondary outcomes
Dentin hypersensitivity
Time frame: baseline, 15 minutes after the treatments, 1 week and 4 weeks.
Change in the dentin hypersensitivity
Time frame: 3 months and 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 20 Oct 2020.
- Derived from this study: PubMed 34676918Machado AC, Maximiano V, Yoshida ML, Freitas JG, Mendes FM, Aranha ACC, Scaramucci T. Efficacy of a calcium-phosphate/fluoride varnish and ionomeric sealant on cervical dentin hypersensitivity: A randomized, double-blind, placebo-controlled clinical study. J Oral Rehabil. 2022 Jan;49(1):62-70. doi: 10.1111/joor.13270. Epub 2021 Nov 2.
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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.
Taís Scaramucci Forlin, Assistant Professor principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluoride Varnish and Glass Ionomer Sealant in people with Dentin Hypersensitivity and Dentin Sensitivity, run by University of Sao Paulo at 1 site in Brazil.
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 3 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 20 Oct 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 Brazil. 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.
What does this phase mean?
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?
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?
Change in the dentin hypersensitivity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04591444, which also lists 1 linked publication.
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 20 Oct 2020.