- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04591444
Fluoride Varnish X Glass Ionomer Sealant on Cervical Dentin Hypersensitivity
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Sao Paulo, Brazil, 05508-000
- School of Dentistry, University of Sao Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ClinproTM White Varnish
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). |
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.
Other Names:
|
Active Comparator: ClinproTM XT Varnish
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). |
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.
Other Names:
|
Placebo Comparator: Placebo Group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the dentin hypersensitivity
Time Frame: 4 weeks
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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. |
4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dentin hypersensitivity
Time Frame: baseline, 15 minutes after the treatments, 1 week and 4 weeks.
|
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. |
baseline, 15 minutes after the treatments, 1 week and 4 weeks.
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Change in the dentin hypersensitivity
Time Frame: 3 months and 6 months
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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). |
3 months and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Taís Scaramucci Forlin, Assistant Professor, University of Sao Paulo
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HDFOUSP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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