Clinical trial NCT04591444: Fluoride Varnish X Glass Ionomer Sealant on Cervical Dentin Hypersensitivity
Official title: Efficacy of a Fluoride Varnish and a Glass Ionomer Sealant on Cervical Dentin Hypersensitivity: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dentin Hypersensitivity
Dentin Sensitivity
Keywords: Dentin hypersensitivity
Dentin sensitivity
Hypersensitivity
Fluorides
Sodium fluoride
Glass ionomer sealant
Desensitizing treatment
Glass ionomer cement
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study is a parallel, randomized, triple blind clinical trial.
Primary purpose: TREATMENT

Brief 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 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the dentin hypersensitivity
timeFrame: 4 weeks
Secondary outcomes:
measure: Dentin hypersensitivity
timeFrame: baseline, 15 minutes after the treatments, 1 week and 4 weeks.
measure: Change in the dentin hypersensitivity
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: School of Dentistry, University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Taís Scaramucci Forlin, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.