Randomised, Controlled, Clinical Study to Compare the Effect of a Combination of Enamel Matrix Proteins and Straumann Bone Ceramic With Autogenous Bone in Deep-wide Intrabony Defects
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in Clinical Attachment Level (CAL)
研究概览
简要总结
Randomised, controlled, clinical study to compare the effect of the combination of bone ceramic and enamel matrix proteins (test) versus autogenous bone graft alone (control) in the treatment of deep-wide intrabony defects
详细描述
30 subjects (15 test and 15 control) diagnosed with moderate to severe periodontitis (Armitage, 1999) will be enrolled in the study and randomized to either the test or the control group.
The surgical procedure shall be performed within 15 days from the baseline visit of the subjects and will be the same for both groups. In both groups, the flap is replaced subsequently.
In total 5 visits per patient are scheduled in this study. The total study duration for each patient should be 12 +/- 2 weeks.
The study devices Emdogain® and Straumann Bone Ceramic are CE-marked, and approved by the FDA.
One center in France will participate.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females must be at least 18 years and not more than 75 years of age
- •The patient will have to be able to understand and sign the informed consent prior to starting the study.
- •The patient also will have to have the ability and the willingness to comply with all study requirements.
- •The patients will be in good general health without any systemic diseases.
- •The teeth included in the study will be mandibular molars, maxillary and mandibular premolars, and canines.
- •The patients will have to have at least one defect with pocket depth ≥ 5 mm.
- •Intra-bony defects will have to have 1 or 2-wall morphology (at least 2/3 of the defect).
- •Depth of the intrabony component of at least 3 mm
- •The selected sites will have to have vertical intra-bony component ≥ 3 mm and an angle ≥ 30 degrees as assessed from standardized intra-oral radiographs.
- •Oral hygiene parameters: Plaque Index (PI) ≤ 20 % and bleeding on probing (BoP) ≤ 20%
排除标准
- •Heavy smokers: more than 20 cigarettes per day
- •Mucosal diseases such as erosive lichen planus
- •History of local radiation therapy
- •Presence of oral lesions (such as ulceration, malignancy)
- •Teeth with untreated endodontic or cardiologic problems
- •Physical handicap that will interfere with patient's ability to exercise good oral hygiene on a regular basis.
- •Patients presenting antibiotic treatment within the 3 months preceding the surgical procedure.
- •Patients using anti-inflammatory drugs on a regular basis.
- •Intra-bony defects with a 3-wall morphology.
- •Intra-bony defects with furcation involvement.
- •Incisors and maxillary molars, will be excluded.
- •Alcoholism or chronically drug abuse causing systemic compromize
- •Medical conditions requiring prolonged use of steroids
- •Current pregnancy at the time of recruitment and/or breastfeeding women.
- •Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
结局指标
主要结局
Change in Clinical Attachment Level (CAL)
时间窗: Baseline and 12 months
CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).
次要结局
- Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect(Baseline and 12 months)
- Change in Clinical Attachment Level (CAL)(Baseline and 6 months)
- Change in Probing Pocket Depth (PPD)(Baseline and 6 months)