Comparative evaluation of breathing convenience and clinical acceptance of a novel mouth breathing device for rubber dam:- A Randomized Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To evaluate and compare the breathing convenience and clinical acceptance of a novel mouth breathing device for use with a rubber dam during dental procedures
研究概览
简要总结
This study investigates the use of a novel mouth-breathing device designed to enhance breathing convenience and clinical acceptance during dental procedures requiring rubber dam isolation. Rubber dams are essential in dentistry for isolating teeth, improving visibility, and preventing microbial contamination. However, they can cause discomfort, especially for patients with restricted nasal breathing.
The randomized clinical study evaluates whether this patented breathing device improves patient comfort and breathing ease compared to standard rubber dam techniques. Patients diagnosed with symptomatic irreversible pulpitis and undergoing endodontic treatment will be recruited. The study involves 36 participants, divided into two groups: one using the novel device with a rubber dam and the other using a standard rubber dam.
The study’s objectives include assessing breathing comfort, clinical acceptance, and the device’s impact on upper airway patency and patient experience during dental treatments. A self-designed questionnaire will capture feedback from patients and clinicians.
The research aims to provide evidence that the new device can reduce discomfort, enhance procedural efficiency, and improve the overall patient experience. This innovative approach could potentially standardize more comfortable practices in dentistry while maintaining high safety and infection control standards. The findings could lead to broader applications of the device across various dental fields, benefiting both patients and clinicians
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between age group of 18-60 years ASA classification 1&2 with maxillary or mandibular single canal, single Rooted teeth diagnosed with Symptomatic Irreversible Pulpitis with normal periapical tissues will be included in the study.
- •Patients requiring dental procedures that necessitate the use of a rubber dam.
- •Patients with no history of respiratory disorders.
- •Patients who provide written informed consent.
排除标准
- •Patients with severe or chronic apical periodontitis will be excluded.
- •Teeth with periapical abscess, granuloma, cyst will be excluded.
- •Medically compromised patients will be excluded.
- •Teeth with complex Root canal anatomy will be excluded.
- •Pregnant and lactating women will be excluded.
- •Patients with respiratory conditions such as asthma or COPD.
- •Patients with cognitive impairments affecting their understanding of the study.
结局指标
主要结局
To evaluate and compare the breathing convenience and clinical acceptance of a novel mouth breathing device for use with a rubber dam during dental procedures
时间窗: 1 hour
次要结局
- Comparative Evaluation of Breathing Convenience and Clinical Acceptance of a New Patented Mouth Breathing Device for Rubber Dam: A Randomized Clinical Study.Comparative Evaluation and Clinical Acceptance of a New Patented Mouth Breathing Device for Rubber Dam.(1 year)
研究者
Geetanjali jain
KM DENTAL COLLEGE and HOSPITAL