Multicenter, Randomized, Split-mouth Study to Evaluate the Acceptance and Preference of Lidocaine Gel Compared to Injection Anesthesia After Non Surgical Periodontal Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 5
- 主要终点
- Acceptance and preference of topical lidocaine mouth gel anesthesia
研究概览
简要总结
This project is a national, open label, multicenter, randomized split-mouth study in patients from 18 to 70 years of age to compare the efficacy and acceptability of lidocaine gel compared to injection anesthesia with articaine (infiltration anesthesia for the upper jaw and infiltration or nerve block anesthesia for the lower jaw). It is planned that about 90 patients with a proven moderate periodontitis will be enrolled in 5 German study centers.
Dynexan Mundgel® (lidocaine hydrochloride) is a topical anesthetic gel containing lidocaine that is commercially available as an anesthetic for temporary, symptomatic treatment of pain at the oral mucosa, gingiva and lips. The gold standard for scaling and root planing (SRP) is still the use of injection anesthesia. This raises the question what kind of anesthesia patients would prefer if they had a free choice.
For this study Ultracaine® D-S 1:200,000 (articaine hydrochloride/epinephrine hydrochloride) was selected as the injectable comparator drug because it is the most frequently used anesthetic drug for infiltration and nerve-block anesthesia in Germany at present.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent must be available
- •Willingness and ability to comply with scheduled visits, treatment plan, and other study procedures
- •Patient systemically healthy except for controlled diabetes and hypertension
- •Patients with comparable periodontal status of the right and left jaw, with ≥ 3 teeth with pockets ≥ 4 mm and ≤ 7 mm per quadrant
- •Female patients of childbearing potential must practice highly effective contraception methods
排除标准
- •Generalized severe periodontitis with pockets > 8 mm
- •More than 2 pockets > 7 mm and ≤ 8 mm per quadrant
- •Contraindicated for treatment with the investigational product, the comparator drug, or meet warnings and precautions for use specifications in accordance with the approved SmPCs as follows:
- •Hypersensitivity to the investigational product, the comparator drug or to any of their respective excipients
- •Hypersensitivity to other local anesthetics of the amide type
- •Severe uncontrolled and untreated excitation and conduction disorder of the heart
- •Acute decompensated heart failure
- •Severe renal or hepatic disease/dysfunction
- •Untreated or uncontrolled diabetes type 2
- •Severe hypertension and severe hypotension
- •Narrow-angle glaucoma
- •Hyperthyroidism
- •Paroxysmal tachycardia or high-frequency absolute arrhythmia
- •Myocardial infarction within the last 6 months
- •Coronary artery bypass within the last 3 months
- •Concurrent use of non-cardio selective beta blockers (e.g. propranolol)
- •Pheochromocytoma
- •Concurrent treatment with tri-cyclic antidepressants or monoamine oxidase (MAO) inhibitors
- •Use of painkillers or anti-inflammatory drugs 24 hours before the first treatment
- •Antibiotic prophylaxis or treatment with antibiotics
- •Use of any anxiolytic medication
- •Periodontal treatment within the last 3 months
- •Continuing orthodontic treatment
- •Concurrent use of another investigational medication
- •Participation in another clinical trial within the last 3 months
- •Women who are pregnant or breastfeeding, or planning pregnancy while enrolled in the study
- •Persons who are in a dependency or working relationship with the sponsor or investigator
- •A subject who, in the opinion of the investigator will be uncooperative or unable to comply with study procedures
研究组 & 干预措施
Lidocaine/Articaine
Lidocaine Hydrochloride 1% Gel anesthesia / Articaine hydrochloride/epinephrine (adrenaline) hydrochloride anesthesia
干预措施: Lidocaine Hydrochloride 1% Gel (Drug)
Lidocaine/Articaine
Lidocaine Hydrochloride 1% Gel anesthesia / Articaine hydrochloride/epinephrine (adrenaline) hydrochloride anesthesia
干预措施: Articaine hydrochloride/epinephrine (adrenaline) hydrochloride (Drug)
Articaine/Lidocaine
Articaine hydrochloride/epinephrine (adrenaline) hydrochloride anesthesia / Lidocaine Hydrochloride 1% Gel anesthesia
干预措施: Lidocaine Hydrochloride 1% Gel (Drug)
Articaine/Lidocaine
Articaine hydrochloride/epinephrine (adrenaline) hydrochloride anesthesia / Lidocaine Hydrochloride 1% Gel anesthesia
干预措施: Articaine hydrochloride/epinephrine (adrenaline) hydrochloride (Drug)
结局指标
主要结局
Acceptance and preference of topical lidocaine mouth gel anesthesia
时间窗: 1 hour post-dose of second treatment
To compare acceptance and preference of topical lidocaine mouth gel anesthesia vs. injection anesthesia with articaine in patients undergoing subgingival debridement by comparing the proportion of patients after the second periodontal treatment who prefer topical anesthesia with lidocaine gel against the injection anesthesia with articaine to a proportion of 0.5; the patient rates the preferred anesthesia method on a questionnaire by stating if the patient's preference is treatment with anesthetic gel, treatment with anesthetic injection, or no preference
次要结局
- Duration of anesthetic effect(1 hour post-dose)
- Patient compliance(1 hour post-dose)
- Treating physicians preference(1 hour post-dose of second treatment)
- Re-Evaluation of patients preference(25 hours post-dose of second treatment)
- Assessment of pain(1 hour post-dose)
- Side Effects(1, 5, 25 hours post-dose)
- Overall patient satisfaction with anesthesia(1 hour post-dose)
- Willingness to pay(1 hour post-dose of second treatment)
- Handling/Application(1 hour post-dose)
- Onset of anesthetic effect(1 hour post-dose)
- Anesthesia re-application/rescue anesthesia(1 hour post-dose)