Straumann® Emdogain® Application In Conjunction With Minimally Invasive Surgical Technique For Periodontal Disease Treatment: A Split-Mouth Design Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 8
- 主要终点
- Change in Clinical Attachment Levels (CAL)
研究概览
简要总结
The aim of this controlled study is to assess the clinical outcomes and patient reported outcomes of using minimally invasive surgical procedure with Straumann Emdogain as an adjunct (test treatment) or without Straumann Emdogain (control treatment).
详细描述
The aim of the study will be achieved through the following primary and secondary objectives. The primary objective is to evaluate the regenerative potential of Straumann Emdogain by comparing the change in clinical attachment level from baseline to 12 months between the test and control arms. The regenerative potential of Straumann Emdogain will also be assessed by comparing the changes in gingival margins, changes in average probing pocket depth, changes in full mouth plaque score, changes in bleeding on probing, and changes in root dentin hypersensitivity from baseline to 12 months between the test and control arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must have voluntarily signed the informed consent form before any study related procedures
- •Subjects must be males or females who are 18-85 years of age
- •Subjects must have moderate to severe chronic, generalized periodontitis with pockets of 5 mm - 8mm probing depth in at least 2 pockets per contralateral quadrants in one arch (study teeth)
- •Subjects must be committed to the study and the required follow-up visits
- •Subjects must be in good general health as assessed by the Investigator
排除标准
- •Subjects taking or intending to take any medications during the duration of the study that will potentially affect healing and inflammation
- •Subjects who are currently heavy smokers (defined >10 cigarettes per day or >1 cigar per day) or who use chewing tobacco
- •Subjects being treated with systemic antibiotics or subjects that were treated with systemic antibiotics within 3 months prior to treatment in this study
- •Subjects with uncontrolled diabetes
- •Subjects that are immunocompromised or immunosuppressed
- •Subjects that cannot provide informed consent
- •Subjects with drug or alcohol abuse
- •Subjects that have undergone periodontal root planing or periodontal surgery in the last 6 months
- •Subjects that are pregnant
- •Subjects with necrotizing periodontitis or periodontitis related to systemic disease
- •Teeth with pockets with probing depth ≥ 9 mm will not classify as study teeth
- •Teeth with pockets or defects with furcation involvement will not classify as study teeth
- •Teeth with mobility degree > 1 without splint will not classify as study teeth
- •Subjects with test and control sites in the two quadrants on adjacent teeth
- •Patients with compromised health conditions such as diabetes, systemic diseases, high dose steroid therapy, bone metabolic diseases, radiation or immune-oppressive therapy, and infections or vascular impairment at the surgical site
- •Subjects with conditions or circumstances, in the opinion of the Investigator , which would prevent completion of study participation or interfere with analysis of study results
研究组 & 干预措施
Test (with Emdogain)
Scaling and root planing with Emdogain
干预措施: Scaling and root planing (Procedure)
Test (with Emdogain)
Scaling and root planing with Emdogain
干预措施: Emdogain application (Device)
Control (without Emdogain)
Scaling and root planing without Emdogain
干预措施: Scaling and root planing without Emdogain (Procedure)
结局指标
主要结局
Change in Clinical Attachment Levels (CAL)
时间窗: Baseline and 12 Month Follow-Up Visit
CAL will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of CAL from baseline measurements at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of CAL for test and control treatment arms.
次要结局
- Change in Post-surgical Pain(1-2 days post surgery, 1 week post surgery, and 2 weeks post surgery)
- Change in Gingival Margin (GM)(Baseline and 12 Month Follow-Up Visit)
- Change in Pocket Probing Depth (PPD)(Baseline and 12 Month Follow-Up Visit)
- Change in Full Mouth Plaque Score (FMPS)(Baseline and 12 Month Follow-Up Visit)
- Change in Bleeding on Probing (BoP)(Baseline and 12 Month Follow-Up Visit)
- Change in Root Dentin Hypersensitivity(Baseline and 12 Month Follow-Up Visit)