6-month Clinical Investigation Assessing the Efficacy of an Antimicrobial Mouthrinse in Reducing Established Plaque and Improving Gum Health

Официальное название

Clinical Investigation to Assess the Efficacy of an Antimicrobial Mouthrinse in the Reduction of Established Plaque and the Improvement of Gum Health: a 6-month Clinical Study

Обзор

The goal of this clinical trial is to evaluate the clinical efficacy of an antimicrobial mouthrinse, with a particular focus on its effect on established plaque and the improvement of gum health. Participants will: * Brush and rinse twice a day with the designated products for 6 months * Visit the clinic once every 3 months after baseline for reassessment.

Вмешательства

• Другое Test Mouthrinse
  Test Mouthrinse: 0.0553% NaF (250 ppm Fluoride), Amine and 0.2% Zinc Lactate dihydrate
• Другое Control Mouthrinse
  Control Mouthrinse: 0.0553% NaF(250 ppm Fluoride)

Первичные конечные точки

• Improvement of gum health as measured by the Gingival Index (Löe 1967) between the study groups. [Срок оценки: 6-month period]

Вторичные конечные точки (1)

• Plaque scores as measured by the Plaque Index (Turesky et al. 1970) between the study groups [Срок оценки: 6-month period]

Критерии участия

Критерии включения

• Male and female subjects aged 18-70 years, inclusive.
• Availability for the 6-month duration of the clinical research study.
• Good general health based on the opinion of the study investigator.
• Signed Informed Consent Form.
• Minimum of 20 natural teeth (excluding third molars).
• Initial gingivitis index of at least 1.5 as determined by the use of the Loe and Silness Gingival Index.
• Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).

Критерии исключения

• Be under orthodontic treatment.
• Presence of partial removable dentures.
• Tumor(s) of the soft or hard tissues of the oral cavity.
• Participants with current moderate or severe periodontitis (periodontitis screening index \[PSI\] >2 in more than 2 sextants or PSI >3), and/or purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone.
• Five or more carious lesions requiring immediate restorative treatment.
• Antibiotic use any time during the one-month period prior to entry into the study.
• Participation in any other clinical study or test panel within the one month prior to entry into the study.
• Dental prophylaxis during the past two weeks prior to baseline examinations.
• History of allergies to oral care/personal care consumer products or their ingredients.
• On any prescription medicines that might interfere with the study outcome based on the examiner/PI opinion.
• An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
• History of alcohol and/or drug abuse.
• Self-reported pregnancy and/or lactating subjects.
• Subjects with other oral diseases (including gingival hyperplasia, diseases of the oral mucosa), or any condition that the dental examiner considers exclusionary from the study.
• Smokers or/and users of tobacco products.
• Enrolled in an undergraduate, postgraduate, or academic dentistry program

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

Германия · 1 центр

• SGS proderm GmbH — Schenefeld

Идентификаторы

NCT: NCT07414173 · CRO-2025-10-PG-MER-MW-ZM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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