Clinical Efficacy of Using Bioactive Desensitizer Gel

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

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 Overview

• Status: Completed
• Conditions: Dentin Hypersensitivity; Dentin Desensitizing Agents; Dentin Hypersensitivity, Non-carious Cervical Lesions
• Intervention / Treatment: Procedure: Treatment; Procedure: Treatment

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bioactive Desenstizer; 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	Procedure: Treatment; 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; Procedure: Treatment; 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.
Active Comparator: sodium fluoride varnish	Procedure: Treatment; 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; Procedure: Treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from the Baseline, 1 week, 1 months, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; = subject response but will continue; = subject responds and moves or requests discontinuation; = painful response to stimulus, discontinuation requested.	Change from the Baseline, 1 week, 1 months, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Actual): September 20, 2025
• Study Completion (Actual): December 20, 2025

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Dentin hypersentivity
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dentin Sensitivity; Therapeutics
• Other Study ID Numbers: Cons 25/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No