Comparative evaluation of patient experience with Nitrous Oxide Sedation and Local Anesthesia in Non-Surgical Periodontal Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- 1. Patient-reported anxiety score associated with non-surgical periodontal therapy under nitrous oxide–oxygen inhalation sedation and local anesthesia, measured using a validated anxiety scale (SAI and vital signs).
研究概览
简要总结
This study aims to evaluate and compare nitrous oxide oxygen inhalation sedation combined with local anesthesia and local anesthesia alone during non surgical periodontal therapy. The study will assess anxiety levels, pain perception, treatment comfort, and patient satisfaction. By identifying whether nitrous oxide offers additional benefits over local anesthesia alone, the study may help improve patient experience, compliance, and overall treatment outcomes in periodontal care. The findings may also support the use of nitrous oxide inhalation sedation as a routine clinical option in periodontal procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adults (18-65 years) of either sex with moderate to severe periodontitis.
- •Patients with no prior dental experience with a need for scaling and root planing in at least two quadrants.
- •Patients with an ability to understand and sign informed consent.
- •No contraindications for nitrous oxide inhalation sedation or local anesthesia.
- •Patients satisfied with American Society of Anesthesiologists (ASA) grade I and II.
排除标准
- •Severe systemic health issues (ASA Grade III or higher).
- •History of allergic reactions to local anesthesia or nitrous oxide
- •Pregnancy or lactation states
- •Severe dental anxiety that may require alternate sedation techniques
- •Patients who had deep dental cleaning in the past
- •Current middle ear surgery
- •Patients on bleomycin sulphate therapy
- •Patient who were mouth breathers/ had claustrophobia/ unwilling to accept nasal hood 9.Patients who had upper respiratory tract infections (common cold, accute or chronic sinus, bronchitis cough, tuberculosis, emphysema) or any other serious respiratory ailment
- •Not willing for Nitrous Oxide Inhalation Sedation.
结局指标
主要结局
1. Patient-reported anxiety score associated with non-surgical periodontal therapy under nitrous oxide–oxygen inhalation sedation and local anesthesia, measured using a validated anxiety scale (SAI and vital signs).
时间窗: 1. Anxiety levels: Pre-operative, intra-operative, and immediately post-operative for both treatment conditions. | 2. Pain levels: Immediately after local anesthetic administration and 15 minutes after onset of instrumentation during each treatment session. | 3. Patient Satisfaction Levels: Immediately after completion of each treatment session , within the 2-week treatment period.
2. Patient-reported intra-operative pain score during non-surgical periodontal therapy with nitrous oxide–oxygen inhalation sedation and local anesthesia, measured using a validated pain scale (VAS).
时间窗: 1. Anxiety levels: Pre-operative, intra-operative, and immediately post-operative for both treatment conditions. | 2. Pain levels: Immediately after local anesthetic administration and 15 minutes after onset of instrumentation during each treatment session. | 3. Patient Satisfaction Levels: Immediately after completion of each treatment session , within the 2-week treatment period.
3. Post-operative patient satisfaction during non-surgical periodontal therapy performed with nitrous oxide–oxygen inhalation sedation and local anesthesia, assessed using a patient satisfaction questionnaire.
时间窗: 1. Anxiety levels: Pre-operative, intra-operative, and immediately post-operative for both treatment conditions. | 2. Pain levels: Immediately after local anesthetic administration and 15 minutes after onset of instrumentation during each treatment session. | 3. Patient Satisfaction Levels: Immediately after completion of each treatment session , within the 2-week treatment period.
次要结局
- (i) duration of procedure recorded using a stopwatch from onset of instrumentation to completion under each anesthetic protocol, and((ii) clinical periodontal parameters (PD, CAL, BOP) assessed at baseline and at 2-week follow-up in both quadrants.)
研究者
Dr Ruchi Ramanujan
A B Shetty Memorial Institute of Dental Sciences