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

Официальное название

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)

Обзор

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

Вмешательства

• Процедура 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
• Процедура 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.

Первичные конечные точки

• Degree of Dentin hypersensitivity [Срок оценки: change from the baseline, 1month, 2months, 4 months, 6 months after treatment]

Вторичные конечные точки (2)

• Examiner Assessment to level of patient pain [Срок оценки: change from the baseline, 1month, 2months, 4 months, 6 months after treatment]
• Patient satisfaction with the Treatment [Срок оценки: change from the baseline, 1month, 2months, 4 months, 6 months after treatment]

Критерии участия

Критерии включения

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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Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Cairo University — Cairo

Идентификаторы

NCT: NCT07120139 · CONS2R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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