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NCT Number: NCT07120139

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

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

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Key information

Conditions

Dentin Hypersensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

22 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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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.

Treatment and study plan

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

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.

Primary outcomes

  1. Degree of Dentin hypersensitivity

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

    Visual analog scale (VAS)

Secondary outcomes

  1. Examiner Assessment to level of patient pain

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

    Schiff sensitivity scale [SSS]

  2. Patient satisfaction with the Treatment

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

    4-point Likert scale

Study contacts

Contact information is provided by the study sponsor or research team.

Rawda Hesham Abd ElAziz

CONTACT

[email protected]

+201001097200

Sponsors and collaborators

Lead sponsor

Rawda Hesham Abd ElAziz

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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