An Open-label, Single-Arm, Single-Centre Clinical Study To Evaluate The Safety And Efficacy Of Akayu Dantvam In Improvement Of Oral Hygiene
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Reduction in Sensitivity to Hot and Cold:
研究概览
简要总结
Background and Introduction
This clinical trial aims to evaluate the safety and efficacy of Akayu Dantvam, an innovative oral care product formulated to enhance oral hygiene. Poor oral hygiene is associated with dental issues such as plaque buildup, gingivitis, periodontitis, dental caries, and halitosis, which can lead to discomfort, pain, and potentially severe systemic health problems. Akayu Dantvam is designed to provide comprehensive dental care by reducing plaque, alleviating gingival inflammation, preventing dental caries, and eliminating bad breath. The study will be conducted as an open-label, single-arm, single-center trial to assess the effectiveness of Akayu Dantvam in improving oral hygiene and overall dental health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 13.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age Range: Individuals aged 13 to 70 years.
- •2.Oral Health Status: Participants with mild to moderate gingivitis, plaque accumulation, or dental sensitivity.
- •3.Oral Hygiene Practices: Willingness to use Akayu Dantvam as the sole oral care product during the study period.
- •4.Informed Consent: Ability and willingness to provide written informed consent (for minors, consent must be obtained from a parent or guardian).
- •5.Compliance: Ability and willingness to comply with all study procedures and visits.
排除标准
- •1.Severe Oral Conditions: Presence of severe periodontal disease, severe dental caries, or other significant oral pathologies that may interfere with the study.
- •2.Recent Dental Procedures: Participants who have undergone major dental procedures (such as extractions, implants, or periodontal surgery) within the last three months.
- •3.Systemic Conditions: Presence of systemic conditions or diseases that affect oral health (e.g., uncontrolled diabetes, immunocompromised status).
- •4.Allergies: Known allergy or hypersensitivity to any component of Akayu Dantvam.
- •5.Concurrent Participation: Participation in another clinical trial within the last 30 days or current participation in another clinical study.
- •6.Pregnancy or Lactation: Pregnant or lactating women.
- •7.Non-compliance: Any condition or situation that, in the investigator’s opinion, may interfere with the participant’s ability to comply with the study requirements or pose a risk to their safety.
结局指标
主要结局
1.Reduction in Sensitivity to Hot and Cold:
时间窗: Day 0, Day 14 and Day 30
Measurement Tool: Visual Analog Scale.
时间窗: Day 0, Day 14 and Day 30
Description: Assessment of changes in dental sensitivity to thermal stimuli (hot and cold) as reported by participants.
时间窗: Day 0, Day 14 and Day 30
2.Reduction in Plaque Accumulation:
时间窗: Day 0, Day 14 and Day 30
Measurement Tool: Plaque Index or Modified Quigley-Hein Plaque Index (MQHPI).
时间窗: Day 0, Day 14 and Day 30
Description: Evaluation of the amount of dental plaque on tooth surfaces before and after using Akayu Dantvam.
时间窗: Day 0, Day 14 and Day 30
3.Decrease in Gingival Bleeding:
时间窗: Day 0, Day 14 and Day 30
Measurement Tool: Gingival Bleeding Index.
时间窗: Day 0, Day 14 and Day 30
Description: Measurement of the extent of gingival bleeding as an indicator of gingival health and inflammation.
时间窗: Day 0, Day 14 and Day 30
4.Elimination of Halitosis:
时间窗: Day 0, Day 14 and Day 30
Measurement Tools: Organoleptic assessment and patient-reported outcomes.
时间窗: Day 0, Day 14 and Day 30
Description: Evaluation of the presence and severity of bad breath before and after using Akayu Dantvam.
时间窗: Day 0, Day 14 and Day 30
次要结局
- 1. Reduction in Gum Swelling.(2. Prevention of Tooth Loosening.)
研究者
Dr Monica Rao
Tash Dent A Multispeciality Dental Care Clinic