Effect of Local Anesthesia in Patients With Marginal Periodontitis Undergoing Scaling and Root Planning
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- To demonstrate a non-inferior effect on pain and discomfort during scaling and root planning by a bupivacaine lozenge in comparison to lidocaine-adrenalin injections.
研究概览
简要总结
A randomised cross-over study comparing two methods of local anaesthesia for patients diagnosed with periodontitis undergoing scaling and root planning. 40 patients will be included in the study, which aims to demonstrate that the effect of a bupivacaine lozenge is non-inferior to lidocaine-adrenalin injections.
详细描述
40 periodontitis patients undergoing scaling and root planning (SRP) will be randomised to receive local anaesthesia by either a bupivacaine lozenge or lidocaine-adrenalin injection at their first visit. At the following visit, the patients will receive the opposite treatment.
At each visit the patient will evaluate pain before, during and after SRP by:
- Visual Analog Scale (VAS) 0-10 where 0 = no pain, 10 = extreme pain.
- McGills Pain Questionnaire (MPQ), which gives a qualitative pain profile.
At each visit the patient will evaluate discomfort before, during and after the SRP by:
- Visual Analog Scale (VAS) 0-10 where 0 = no discomfort, 10 = extreme discomfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as having, respectively periodontitis marginalis adulta progressiva lenta and periodontitis marginalis adulta progressiva rapid in the hygiene phase, where depurations are repeated within a short timeframe
- •Age between 18 and 80 years
- •Ability to speak, read and understand danish
- •Ability to give oral and written consent
排除标准
- •Known allergy to bupivacaine or other local anaesthetics of the amide type
- •Other gingival infections (eg lichen planus)
- •Pregnancy -if in doubt a pregnancy test will be made
- •Breastfeeding
研究组 & 干预措施
Bupivacaine lozenge
Single dose administration of a 25 mg bupivacaine lozenge before the scaling and root planning was performed.
干预措施: Bupivacaine lozenge (Drug)
Lidocaine-adrenalin injection
Xyloplyin Dental Adrenalin (20 mg/ml lidocaine, 12.5 microgram/ml adrenaline). Frequency and duration of injections was decided by the dentist preforming the scaling and root planning.
干预措施: Lidocaine-adrenalin injection (Drug)
结局指标
主要结局
To demonstrate a non-inferior effect on pain and discomfort during scaling and root planning by a bupivacaine lozenge in comparison to lidocaine-adrenalin injections.
时间窗: Day 1
Pain and discomfort are measured immediately after the scaling and root planning procedure Level of discomfort: -Visual Analog Scale (VAS) 0-10 where 0 = no discomfort, 10 = extreme discomfort
次要结局
- To demonstrate a non-inferior effect on pain and discomfort during scaling and root planning by a bupivacaine lozenge in comparison to lidocaine-adrenalin injections.(Daiy 1)
- Investigator evaluation of the scaling procedure(Day 1)
- Patient assessment of the two pharmaceutical formulations(Day 1)
研究者
Ove Andersen
MD
Hvidovre University Hospital