Clinical Efficacy of Using Bioactive Desensitizer Gel

Cairo University30 enrolled

Overview

To evaluate and compare the clinical effectiveness of a Bioactive Desensitizer Gel (which releases calcium and phosphate to form hydroxyapatite) versus a standard 5% Sodium Fluoride (NaF) Varnish in reducing cervical dentin hypersensitivity (CDH) in adult patients over a period of 6 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dentin Desensitizing Agents Dentin Hypersensitivity, Non-carious Cervical Lesions Dentin Hypersensitivity

Interventions

TreatmentPROCEDURE

A micro-brush applicator was saturated with the material (Predicta Bioactive Desensitizer Gel) and massaged it into the tooth for 30-40 secs. Using a rubbing motion was used to liquefy the gel and allow it to penetrate the surface

TreatmentPROCEDURE

the sodium fluoride (Proshield) varnish, was painted with a disposable micro-brush on the sensitive surface as per the instructions for 60 seconds from the manufacturer.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * • With ≥1 sensitive tooth and with exposed dentin in the upper or lower dental arches. * Grade IV gingival recession. * Schiff sensitivity score needed to be ≥2, indicating that application of a jet of air makes the patient respond and move or requests discontinuation of the stimuli application. Exclusion Criteria: * • Domestic or in-office fluoride application and bleaching 6 months before beginning of treatment * Long-term use of anti-inflammatory, analgesic and psychotropic drugs. * Allergies to product ingredients * Eating disorders, systemic conditions that cause or predispose patients to develop dentin hypersensitivity (for example, gastroesophageal reflux disease, GERD) * Excessive dietary or environmental exposure to acids. * Orthodontic appliance treatment within the previous three months. * Periodontal surgery within the previous three months before the study

Locations (1)

Faculty of Dentistry

Cairo, Egypt

Outcomes

Primary Outcomes

Visual analog scale (VAS)

A VAS is a line that is 10 cm in length, the extremes of which represent the limits of pain, a patient may experience an external stimulus (The left endpoint designated no pain was marked as 0 and the right endpoint designated sever pain was marked as 10). Patients will be asked to place a mark on the 10 cm line that indicated their dentin hypersensitivity intensity

Time frame: Change from the Baseline, 1 week, 1 months, 3 months, 6 months

Secondary Outcomes

Level of Pain Assessment using The Schiff sensitivity scale

It was used to assess dentin hypersensitivity. A score of 0, 1, 2 or 3 was assigned 0 = no subject response to stimulus 1. = subject response but will continue 2. = subject responds and moves or requests discontinuation 3. = painful response to stimulus, discontinuation requested.

Time frame: Change from the Baseline, 1 week, 1 months, 3 months, 6 months

Data from ClinicalTrials.gov

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