Comparative Study of Caries-Preventive Effects: 2% Calcium Hypophosphite Toothpaste vs. Sodium Fluoride Toothpaste (1450ppm F)

Официальное название

Caries-preventing Effect of 2% Calcium Hypophosphite Toothpaste Compared to a Sodium Fluoride Toothpaste (1450ppm F) in Adults

Обзор

The aim of the study is to compare the caries-preventive effect of the test and control toothpaste in order to proof the non-inferiority of the test toothpaste compared to the control.

Вмешательства

• Устройство 2% Calcium Hypophosphite Toothpaste
  Oral hygiene instruction and regular application of the 2% Calcium Hypophosphite Toothpaste at home (twice daily over a period of 546 days, i.e., 18 months).
• Устройство Sodium Fluoride Toothpaste (1450 ppm F)
  Oral hygiene instruction and regular application of the Sodium Fluoride Toothpaste at home (twice daily over a period of 546 days, i.e., 18 months).

Первичные конечные точки

• Evaluate the efficacy of the 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) regarding the Decay-Missing-Filled index [Срок оценки: Day 1, Day 182±28, Day 365±28 vs. Day 546±28]

Вторичные конечные точки (2)

• Evaluate the efficacy of the 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) in the prevention of interproximal caries lesions [Срок оценки: Day 1 vs. Day 546±28]
• Evaluate the efficacy of 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) in the prevention of dental plaque deposition using the Plaque Control Record (PCR) index [Срок оценки: Day 1, Day 182±28, Day 365±28 vs. Day 546±28]

Критерии участия

Критерии включения

• A minimum of 10 healthy molars and premolars (DMFS of these teeth = 0)
• Willingness to use an electric (powered) toothbrush
• Willingness to use interdental floss
• Willingness to have bitewing radiographs taken
• Willingness to undergo an oral examination by an intraoral camera (DIAGNOcam)

Критерии исключения

• Untreated caries \[clinical investigation and analysis with an intraoral camera (DIAGNOcam)\] (→ unsuitable subjects with one or two untreated caries in need of a restoration can become eligible after restorative therapy. If there are three or more untreated caries patients will be excluded)
• Xerostomia (medication, radiation, disease induced)
• Chemo/radiation therapy
• Physical or mental disability which prevents proper oral health care
• Orthodontic treatment
• Severe periodontitis at the Baseline Visit (pocket depth on at least one tooth ≥ 5.5 mm)
• Known hypersensitivity to one of the ingredients of the toothpastes to be tested
• Regular medication intake interfering with salivary function or flow
• Current pregnancy, the wish to become pregnant, the suspicion of being pregnant, or breastfeeding or in the course of the study
• 3 or more carious lesions/restorations in last 36 months until Baseline Visit
• Teeth missing due to caries in last 36 months until Baseline Visit

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

Четверное слепое

Основная цель

Профилактика

Центры проведения

Польша · 2 центра

• Department of Integrated Dentistry Medical University of Białystok — Bialystok
• Poznan University of Medical Sciences, Department of Integrated Dentistry — Poznan

Идентификаторы

NCT: NCT07068204 · CA2-04/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗