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

NCT ID: NCT07120139

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-20

Study Completion Date

2026-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Dentin Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

episodic use of the desensitizing toothpaste

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

Group Type EXPERIMENTAL

episodic use of the desensitizing toothpaste

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

Group Type EXPERIMENTAL

episodic use of the desensitizing toothpaste

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

Group Type ACTIVE_COMPARATOR

continuous use of the conventional desensitizing toothpaste

Intervention Type 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.

Interventions

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episodic use of the desensitizing toothpaste

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

Intervention Type PROCEDURE

continuous use of the conventional desensitizing toothpaste

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

\-

Exclusion Criteria

* 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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rawda Hesham Abd ElAziz

OTHER

Sponsor Role lead

Responsible Party

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Rawda Hesham Abd ElAziz

Associate Professor, Conservative dentistry department

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Rawda Hesham Abd ElAziz

Role: CONTACT

+201001097200

Facility Contacts

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Rawda Hesham ElAziz

Role: primary

01001097200

Other Identifiers

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CONS2R

Identifier Type: -

Identifier Source: org_study_id

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