NCT01614925终止不适用
A Randomized, Controlled, Multicenter Clinical Study Evaluating the Outcomes of Periodontal Surgery in Supra-alveolar-type Defects With or Without Straumann® Emdogain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Clinical Attachment Level
研究概览
简要总结
The primary objective of this study is to demonstrate that in supra-alveolar-type defects (i.e., defects displaying a predominately horizontal pattern of bone loss), periodontal surgery with the additional use of Straumann® Emdogain will result in significantly higher Clinical Attachment Level (CAL) gain compared to periodontal surgery without Straumann® Emdogain.
详细描述
The following secondary endpoints will be evaluated during the study:
- Change in Gingival Margin (GM) at 12 months after surgery compared to baseline
- Change in Probing Pocket Depth (PPD) at 12 months after surgery compared to baseline
- Comparison of early wound healing index (EHI) at 4 weeks after surgery between treatment groups
- Comparison of post-surgical pain at 4 weeks after surgery between treatment groups
- Change in Bleeding on Probing (BoP) at 12 months after surgery compared to baseline
- Change in root dentin hypersensitivity at 12 months after surgery compared to baseline
- Change in full mouth plaque index (PI) at 12 months after surgery compared to baseline
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have advanced periodontitis:
- •presence of supra-alveolar-type defects (i.e., defects displaying a predominantly horizontal pattern of bone loss) at a minimum of two adjacent teeth and a maximum of 7 adjacent teeth (FDI positions 17-27 or 37-47) in either the maxilla or the mandible with a PPD of ≥6 mm at a minimum on one site of the examined teeth
- •Teeth must have < Class II mobility
- •Teeth must have horizontal bone loss with an intrabony component of <2 mm as defined by radiographic evaluation
- •Subjects must have adequate oral hygiene (full mouth plaque index (PI) of <25% at baseline (i.e., following initial non-surgical periodontal therapy)
- •Subjects must have adequate control of inflammation (full mouth bleeding on probing (FMBP) of <25% at baseline (i.e., following initial non-surgical periodontal therapy)
- •Subjects must have voluntarily signed the informed consent form before any study related procedures
- •Subjects must be males and females of at least 18 years of age
- •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 at time of surgery
排除标准
- •Pre-surgical exclusion criteria:
- •Subjects with any contraindications for oral surgical procedures
- •Subjects with uncontrolled diabetes or other uncontrolled systemic diseases
- •Subjects with disorders or treatments that compromise wound healing
- •Subjects with medical conditions requiring chronic high dose steroid therapy
- •Subjects with bone metabolic diseases
- •Subjects with radiation or other immuno-oppressive therapy
- •Subjects with infections or vascular impairment at the surgical site
- •Subjects who are on antibiotic treatment or chronic anti-inflammatory treatment (≥3 times per week) within 4 weeks prior to surgery.
- •Subjects with the presence of oral lesions (such as ulceration, malignancy)
- •Subjects with mucosal diseases (e.g., lichen planus, mouth ulcer)
- •Subjects with a history of malignant disease in the oral cavity or previous radiotherapy to the head or neck
- •Subjects with inadequate oral hygiene or unmotivated for adequate home care
- •Subjects that have been treated with an investigational drug or device within the 30 day period immediately prior to surgery on study day
- •Subjects who currently smoke
- •Female subjects who are nursing, pregnant, or plan to become pregnant
- •Secondary exclusion criteria:
- •Subjects with an osseous defect with an intrabony component of ≥2 mm or involving furcation involvement ≥ class II at the tooth of interest
结局指标
主要结局
Clinical Attachment Level
时间窗: 12 Months
The change in Clinical Attachment Level (CAL) from Baseline to 12 Months. CAL measurements will be derived from the Probing Pocket Depth (PPD) and Gingival Margin (GM) measurements as follows: CAL = PPD - GM.
次要结局
- Change in Plaque Index (PI) From Baseline to 12 Months(12 months after baseline)
- Change in Gingival Margin (GM) From Baseline to 12 Months(12 months after baseline)
- Comparison of Post-surgical Pain at 4 Weeks After Baseline(4 weeks after baseline)
- Change in Bleeding on Probing (BoP) From Baseline to 12 Months(12 months after baseline)
- Change in Probing Pocket Depth (PPD) From Baseline to 12 Months(12 months after baseline)
- Early Wound Healing Index (EHI) Assessment at 4 Weeks After Baseline(4 weeks after baseline)
- Change in Root Dentin Hypersensitivity (RDH) From Baseline to 12 Months(12 months after baseline)
研究者
研究点 (2)
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