Clinical Effectiveness of Episodic Use of Bioactive Silica Based Versus in Management of Dentin Hypersensitivity (A 6m Randomized Clinical Trial)

NCT07120139 | Not Yet Recruiting DMC

• 1 other identifier: CONS2R
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study to compare the clinical effectiveness of Episodic use of Bioactive Silica Based versus continuous use of fluoride based desensitizing toothpastes in management of dentin hypersensitivity (DH) of adult patients over 6m follow up and evaluating patient satisfaction regarding the treatment provided. Episodic use will be tested as it reflects the effectiveness in a clinical scenario regarding patient compliance and adherence to the treatment where some of the Egyptian patients stop the treatment once improvement occurs due to financial constraints

Conditions

Dentin Hypersensitivity

Keywords

Bioactive Silica Based with calcium booster (Refix technology) toothpaste; Dentin hypersensitivity.

Outcome Measures

Primary Outcomes (1)

• Degree of Dentin hypersensitivity

  Visual analog scale (VAS)

  change from the baseline, 1month, 2months, 4 months, 6 months after treatment

Secondary Outcomes (2)

• Examiner Assessment to level of patient pain

  change from the baseline, 1month, 2months, 4 months, 6 months after treatment

• Patient satisfaction with the Treatment

  change from the baseline, 1month, 2months, 4 months, 6 months after treatment

Study Arms (4)

Group 1 Episodic use of Refix booster Bioactive Silica with calcium booster toothpaste

EXPERIMENTAL

Procedure: episodic use of the desensitizing toothpaste

Group 2: Episodic use of Regenerador Sentitive: Bioactive Silica Based toothpaste,

EXPERIMENTAL

Procedure: episodic use of the desensitizing toothpaste

Group 3: Episodic use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste,

EXPERIMENTAL

Procedure: episodic use of the desensitizing toothpaste

Group 4: Continuous use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste

ACTIVE COMPARATOR

Procedure: continuous use of the conventional desensitizing toothpaste

Interventions

episodic use of the desensitizing toothpaste PROCEDURE

subjects assigned to episodic treatment will use the assigned toothpaste with the same previous instructions for two 8-week treatment periods, followed by an 8-week phase in which they will use the conventional fluoride dentifrice (Signal Complete 8 Original, Unilever, Egypt), which has no documented desensitizing efficacy

Group 1 Episodic use of Refix booster Bioactive Silica with calcium booster toothpaste; Group 2: Episodic use of Regenerador Sentitive: Bioactive Silica Based toothpaste,; Group 3: Episodic use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste,

continuous use of the conventional desensitizing toothpaste PROCEDURE

The patients will be instructed to use 1 inch amount of the assigned desensitizing toothpaste and soft bristle toothbrushes with the same brushing technique they will be taught in the intervention visit for 2 minutes twice a day (morning and last thing at night ) without further rinsing, only spitting of the excess material every day along the whole study period for the continuous treatment group.

Group 4: Continuous use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste

Eligibility Criteria

• Age: 22 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with DH, VAS ≥ 3 and 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.
• Teeth with DH related to Non- carious Cervical lesions (abrasion, abfracture, erosion).
• Teeth with gingival recession and exposed root dentin.

You may not qualify if:

• Patients with known allergies or adverse reactions to any ingredient of the tested materials.
• Systematic disease and/ or physical disabilities that may affect participation. • Patients who did any periodontal surgeries within the previous 3 months.
• Patients with orthodontic appliances, or restorative work that might interfere with evaluation.
• Patient who frequently use analgesics or any drugs that could affect the pain level.
• Home or in-office bleaching and/ or in office fluoride application for 6 months before beginning of treatment.
• Pregnant females with frequent vomiting attacks.
• Smokers.
• Systemic conditions that cause or predispose patients to develop dentin hypersensitivity (for example, gastroesophageal reflux disease, GERD).
• Excessive dietary or environmental exposure to acids.

Sponsors & Collaborators

• Rawda Hesham Abd ElAziz: lead

Study Sites (1)

Cairo University

Cairo, 11331, Egypt

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Rawda Hesham Abd ElAziz

CONTACT

+201001097200; rawda.hesham@dentistry.cu.edu.eg

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: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Conservative dentistry department

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: August 20, 2025
• Primary Completion: February 20, 2026
• Study Completion: February 28, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)