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Comparison of Desensitizing Materials

Comparison Between Two Different Desensitizing Materials in Controlling Natural Dentin Hypersensitivity: A Randomized Controlled Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04527159
Enrollment
22
Registered
2020-08-26
Start date
2019-01-06
Completion date
2020-02-24
Last updated
2020-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentin Hypersensitivity

Brief summary

To compare the efficacy of two commercially available in-office desensitizing agents (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity.

Detailed description

Dentine hypersensitivity (DH) is a condition that occurs in non-pathological, non-defective teeth and is defined as a short, sharp pain in response to stimuli, typically thermal, evaporative, tactile, osmotic or chemical and which cannot be attributed to any other dental defect or pathology. The incidence of DH ranges from 4% to 74% in several studies. Mandibular first molars, canines and premolars of both jaws are most commonly affected by DH. The pathogenesis of DH is linked to exposure of dentinal tubules that can occur in the oral cavity due to dental erosion from acidogenic diets, aggressive tooth-brushing, injudicious use of whitening products, gingival recession, periodontal debridement or surgery. The most commonly reported initiating factor is cold drinks. Management usually involves methods that can achieve one or both of the following objectives; i) alteration of fluid flow in the dentinal tubules and ii) modification or blocking of the pulpal nerve response. A broad range of products that achieve these objectives have been developed after rigorous trials and can be used in-office or at home depending on the severity of the condition. These products are commonly referred to as desensitizing agents. Grossman suggested that an ideal desensitizing agent should be non-irritating to the pulp, relatively painless on application, easy to apply, rapid in action, effective for long periods of time and should not stain the teeth. The use of dentine desensitizers has become one of the most common methods in managing DH. The most commonly used desensitizers contain components such as fluoride, triclosan, benzalkonium chloride, ethylene diaminetetraacetic acid and glutaraldehyde. Fluoraphat Pro (Neumunster, Germany) and VivaSens® (Ivoclar Vivadent, Schaan, Liechtenstein, Switzerland) are two agents that have been tested for use as dentine desensitizers and are currently available for commercial use. In the present study, two such varnishes VivaSens (Ivoclar Vivadent, Schaan, Liechtenstein, and Switzerland) and Fluoraphat (Promedical Neumunster, Germany) have been used. The present study aims to establish which of the two desensitizing agents has better efficacy in reducing hypersensitivity in patients who have been previously diagnosed with DH.

Interventions

DRUGFluoraphat Pro / VivaSens

desensitizing agents for treatment of dentinal hypersensitivity

Sponsors

Nourah Mulfi Aljasser
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Males and females aged between 18 and 50 years * Patient should have at least 2 teeth with dentinal hypersensitivity * Sound tooth structure * Willingness to participate in the study

Exclusion criteria

* Gingival recession * Caries * Non-carious lesions (attrition, abrasion, erosion, abfraction) * Teeth restored with dental filling * Fractured or cracked tooth * Microleakage

Design outcomes

Primary

MeasureTime frameDescription
Likert type scale used to measure attitudes or opinions24 HoursLikert type scale grading from 0-4 0: No sensitivity 1. Very mild sensitivity 2. Mild sensitivity 3. Moderate Sensitivity 4. Severe Sensitivity to compare the efficacy of two commercially available in-office desensitizing agents (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026