NCT03162016已完成不适用
Treatment of Multiple Gingival Recession Defects Using a Xenogenic Acellular Dermal Matrix Compared to Connective Tissue Graft: a Randomized Controlled Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Percentage of Root coverage
研究概览
简要总结
Limitation of donor site and significant postoperative morbidity are often described in connective tissue graft harvesting. We want to show if mucoderm used in tunnel technique to recover miller class I and II recessions defects could be an alternative to connective tissue graft.
详细描述
Connective tissue graft harvested from the palate does not always have sufficient size to cover multiple recession defects. Moreover, connective tissue graft shows significant postoperative morbidity to treat generalized multiple gingival recessions. The goal of this study is to show if Mucoderm could be considered has a substitute of connective tissue graft in the coverage of gingival recession defects.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 45 years, postmenopausal women (ie with amenorrhea for more than a year).
- •Subject with bilateral Miller class I or II recessions defects
- •non smoking patients
- •patients having read and understood the information note on the study and signed the informed consent form.
- •patients affiliated to the social security system.
排除标准
- •Patient with absolute contra-indication for dental surgery: valvular heart disease at risk of infectious endocarditis, recent myocardal (≤ 12 months), organ transplants, recent placement of a coronary stent (≤ 12 months), transient ischemic attacks recurrent, cardiovascular instability, uncontrolled epilepsy, rheumatic fever.
- •Patient with metabolic bone disease (Paget's disease, osteomalacia, osteogenesis imperfecta)
- •Patient with an ASA score ≥
- •Patient with absolute contra-indication to dental surgery
- •Patient with severe hematologic disease
- •Patient with I or type II diabetes
- •Patients with previous or current acute illness or severe chronic cardiovascular, renal, hepatic, gastrointestinal, allergic, endocrine, neuro-psychiatric, considered by the investigator to be incompatible with the conduct of the study.
- •Patients treated with retinoids, oral bisphosphonates, oral anticoagulants or anticonvulsants.
- •Patient have or have had cancer of the upper aerodigestive tract treated by radiotherapy.
- •Patient taking a steroidal or non-steroidal anti-inflammatory, anti-cancer or immunosuppressive chemotherapy in the last 6 months.
- •Patient monitoring considered difficult by the investigator.
- •Patient with poor oral hygiene incompatible with oral surgery.
- •Patients with periodontal disease unstabilized
- •Patient with oral dermatitis or adverse occlusion.
- •Patient with an acute or chronic infection of the surgical site (osteomyelitis).
- •Patient with a known allergy to collagen
- •Patient with autoimmune disease
- •Patient with a linguistic or mental incapacity to understand information
- •Patient younger than 45 years old
- •Patient trust under curatorship or judicial protection
- •Patients aged over 45 premenopausal.
- •Patient participating in another clinical study.
结局指标
主要结局
Percentage of Root coverage
时间窗: at 6 month
Comparison of Percentage of Root coverage at baseline and 6 months postoperatively
次要结局
- postoperation pain(at day 10 postoperation)
- postoperation pain(at day 1 postoperation)
- postoperation pain(at day 2 postoperation)
- postoperation pain(at day 3 postoperation)
- postoperation pain(at day 5 postoperation)
研究者
研究点 (1)
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