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OpenTrials
Completed

NCT Number: NCT07323693

Clinical Efficacy of Using Bioactive Desensitizer Gel

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.

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Key information

Conditions

Dentin Desensitizing Agents Dentin Hypersensitivity Dentin Hypersensitivity, Non-carious Cervical Lesions Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment

Procedure

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

Primary outcomes

  1. Visual analog scale (VAS)

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

    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

Secondary outcomes

  1. Level of Pain Assessment using The Schiff sensitivity scale

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

    It was used to assess dentin hypersensitivity. A score of 0, 1, 2 or 3 was assigned 0 = no subject response to stimulus

    • = subject response but will continue
    • = subject responds and moves or requests discontinuation
    • = painful response to stimulus, discontinuation requested.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Efficacy of Using Bioactive Desensitizer Gel Versus Sodium Fluoride Varnish on Cervical Dentin Hypersensitivity in Adult Patients: A 6m Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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