EUCTR2016-005202-19-DE进行中（未招募）1 期
Multicenter, randomized, split-mouth study to evaluate the acceptance and preference of lidocaine gel compared to injection anesthesia after non surgical periodontal treatment - Dynexan Perio Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Patients 18-70 years of age
- •2) Signed informed consent must be available
- •3) Willingness and ability to comply with scheduled visits, treatment plan, and other study procedures
- •4) Patient systemically healthy except for controlled diabetes or hypertension
- •5) Patients with comparable periodontal status of the right and left jaw, with = 3 teeth with pockets = 4 mm and = 7 mm per quadrant
- •6) Female patients of childbearing potential must practice highly effective contraception methods
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1) Generalized severe periodontitis with pockets > 8 mm
- •2) More than 2 pockets > 7 mm and = 8 mm per quadrant
- •3) Contraindicated for treatment with the investigational product, the comparator drug, or meet special 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 MAO inhibitors
- •4) Use of painkillers or anti-inflammatory drugs 24 hours before the first treatment
- •5) Antibiotic prophylaxis or treatment with antibiotics
- •6) Use of any anxiolytic medication
- •7) Periodontal treatment within the last 3 months
- •8) Continuing orthodontic treatment
- •9) Concurrent use of another investigational medication
- •10) Participation in another clinical trial within the last 3 months
- •11) Women who are pregnant or breastfeeding, or planning pregnancy while enrolled in the study
- •12) Persons who are in a dependency or working relationship with the sponsor or investigator
- •13) A subject who, in the opinion of the investigator will be uncooperative or unable to comply with study procedures
研究者
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