A Double-Blind, Placebo-Controlled, Two-Arm, Multi-Center, Phase III Clinical Study to Evaluate the Safety and Efficacy of Ayurdent in Improving Overall Dental and Oral Hygiene
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
研究概览
简要总结
Brief Summary of the Study This is a randomized, double-blind, two-arm, controlled clinical study to evaluate the efficacy and safety of Ayurdent, an Ayurvedic herbal toothpaste, in adults with mild-to-moderate dental complaints. Ayurdent is formulated without SLS, fluoride, triclosan, or artificial additives and contains a blend of herbs such as Triphala, Neem, Salvadora persica, Liquorice, Clove oil, and essential oils. The study will assess the effect of Ayurdent on salivary pH, saliva quality, plaque control, gingival health, tooth sensitivity, enamel protection, breath freshness, and teeth whiteness compared to a placebo/control toothpaste over a defined period. Both participants and investigators will be blinded to the allocation.
Purpose of the Study The purpose of this study is to generate robust clinical evidence supporting the safety and efficacy of Ayurdent in improving overall oral health, including gum health, plaque reduction, enamel protection, sensitivity relief, and breath freshness, thereby validating its use as a clinically effective Ayurvedic oral care product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female, aged 18 to 55 years.
- •Able and willing to provide written informed consent.
- •Subjects with mild to moderate dental hypersensitivity (self-reported or clinically confirmed).
- •Subjects with de ntal plaque (Plaque Inde x greater than equal to 2) at screening.
- •Subjects in generally good health and considered by the Investigator capable of complying with study procedures and scheduled visits.
- •Willingness to refrain from use of any other toothpaste, mouthwash, or oral hygiene products during the study.
排除标准
- •Pregnant or lactating women.
- •Subjects with significant oral pathology, including:.
- •Advanced generalized chronic inflammatory periodontal disease.
- •Gross oral pathology (e.g., tumors, soft tissue lesions).
- •Carious lesions requiring immediate restorative treatment
- •Subjects with orthodontic appliances, or more than one incisor with prosthetic crown/veneer.
- •Subjects with moderate to advanced periodontal disease.
- •History of oral tumors or significant pathology of hard or soft tissues of the oral cavity.
- •Any systemic illness or condition that may interfere with the Investigator’s interpretation of study outcomes.
- •Participation in another clinical drug/device trial within 3 months prior to recruitment.
- •Known allergy or hypersensitivity to any of the ingredients in the investigational product or placebo formulation.
研究者
Ms Arpita Malgi
Samahitha Research Solutions