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

R

Rawda Hesham Abd ElAziz

Status

Not yet enrolling

Conditions

Dentin Hypersensitivity

Treatments

Procedure: episodic use of the desensitizing toothpaste
Procedure: continuous use of the conventional desensitizing toothpaste

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

All

Ages

22 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 4 patient groups

Group 1 Episodic use of Refix booster Bioactive Silica with calcium booster toothpaste
Experimental group
Treatment:
Procedure: episodic use of the desensitizing toothpaste
Group 2: Episodic use of Regenerador Sentitive: Bioactive Silica Based toothpaste,
Experimental group
Treatment:
Procedure: episodic use of the desensitizing toothpaste
Group 3: Episodic use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste,
Experimental group
Treatment:
Procedure: episodic use of the desensitizing toothpaste
Group 4: Continuous use of (Sensodyne Rapid action) Fluoride containing desensitizing Toothpaste
Active Comparator group
Treatment:
Procedure: continuous use of the conventional desensitizing toothpaste

Trial contacts and locations

1

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Central trial contact

Rawda Hesham Abd ElAziz

Data sourced from clinicaltrials.gov

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