EVALUATION OF ALTERATION IN SALIVARY FLOW FOLLOWING ADMINISTRATION OF ATROPINE DROPS SUBLINGUALLY
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To quantitatively assess decrease in salivary secretion post administration of atropine sulphate drops during routine dental procedures.
研究概览
简要总结
Salivation is a double-edged sword in dental practice. It is desired for its protective and healing nature to the oral structures but undesirable due to the need for isolation during most dental procedures. A clean and dry field of operation is a requisite in most of the dental procedures and becomes the parameter deciding the success of majority of treatment modalities. In Pedodontics it becomes essential for painless and quick measures to achieve this isolation so as to initiate maximum co-operation from the child. Atropine sulphate drops have been widely used intra-orally as they are known to decrease salivary secretion due to their muscarinic antagonistic activity. This study aims to evaluate the effect of atropine sulphate drops sublingually in decreasing the salivary flow during the span of a dental procedure. A dose-monitored locally administered drops propose to decrease the salivary secretion in this study and make isolation easier and effortless. They are short-acting with a reversible action so as to provide the patient and operator a safe working window.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 7.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children reporting to OPD for elective dental procedures.
- •Children belonging to group 1–2 (healthy or minor disease) according to the ASA (American Society of Anesthesiologists) Physical Status Classification System.
- •Children with salivary flow above baseline.
排除标准
- •Children with oral mucosal lesions.
- •Children undergoing radiotherapy or chemotherapy.
- •Children on medications for underlying systemic conditions.
- •Known cases of cardiac conditions
- •Children with known allergy to atropine.
结局指标
主要结局
To quantitatively assess decrease in salivary secretion post administration of atropine sulphate drops during routine dental procedures.
时间窗: the salivary flow (stimulated and unstimulated) assessed over 3 time intervals 0 mins, 60 mins and 90 mins
次要结局
- To assess the duration of regression to baseline salivary index post administration of drops.(the decrease in baseline salivary index compared from 0 min, 60 mins and 90 mins.)