Fluoride Varnish X Glass Ionomer Sealant on Cervical Dentin Hypersensitivity

NCT04591444 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2020-10-20

No results posted yet for this study

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.

Conditions

  • Dentin Hypersensitivity
  • Dentin Sensitivity

Interventions

DRUG

Fluoride 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.

DRUG

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.

OTHER

Placebo Group

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.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Taís Scaramucci Forlin, Assistant Professor · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-10-31
Completion
2020-03-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04591444 on ClinicalTrials.gov