Clinical Efficacy of Using Bioactive Desensitizer Gel

NCT07323693 | Completed DMC

• 1 other identifier: Cons 25/4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Dentin hypersentivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Level of Pain Assessment using The Schiff sensitivity scale

  Change from the Baseline, 1 week, 1 months, 3 months, 6 months

Study Arms (2)

Bioactive Desenstizer

EXPERIMENTAL

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

sodium fluoride varnish

ACTIVE COMPARATOR

Procedure: Treatment

Interventions

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

Bioactive Desenstizer

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Conservative dentistry department, Faculty of Dentistry, Cairo University

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: November 20, 2024
• Primary Completion: September 20, 2025
• Study Completion: December 20, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)