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【ChiCTR-INR-16008407】單盲平衡隨機對照臨床試驗－比較以牙周內窺鏡輔助的牙根清創術或以開放翻瓣清創手術處理牙周骨下缺陷的效果差別

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基本信息

登记号

ChiCTR-INR-16008407

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2016-05-03

临床申请受理号

靶点

适应症

Periodontal disease

试验通俗题目

單盲平衡隨機對照臨床試驗－比較以牙周內窺鏡輔助的牙根清創術或以開放翻瓣清創手術處理牙周骨下缺陷的效果差別

试验专业题目

單盲平衡隨機對照臨床試驗－比較以牙周內窺鏡輔助的牙根清創術或以開放翻瓣清創手術處理牙周骨下缺陷的效果差別

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

1. Study Objectives 1.1. Primary Objective 1.1.1. To compare the primary clinical outcome variable, i.e. change of clinical attachment level, and secondary clinical outcome variables at primary surgical site. i.e. periodontal defects with periodontal pocket depth ≥6mm and an intra-bony component ≥3mm, treated by Periodontal Endoscope Assisted Root Surface Debridement or conventional periodontal surgery - Open Flap Debridement. 1.2. Secondary Objectives 1.2.1. To compare the clinical outcome variables at secondary surgical site, i.e. periodontal defects with periodontal pocket depth ≤5mm, treated by Periodontal Endoscope Assisted Root Surface Debridement or conventional periodontal surgery - Open Flap Debridement. 1.2.2. To compare the patient-centered outcomes, during intra-operative and recovery period, from Periodontal Endoscope Assisted Root Surface Debridement and conventional periodontal surgery - Open Flap Debridement. 1.2.3. To compare the time required for Periodontal Endoscope Assisted Root Surface Debridement and conventional periodontal surgery - Open Flap Debridement.

试验分类

试验类型

随机平行对照

试验分期

治疗新技术

随机化

5.3. Randomization Procedure 5.3.1. Therapy assignment A set of randomization code with Block Randomization (Random Block size 2 and 4) Sequentially Numbered, Opaque Sealed Envelopes (SNOSE) will be prepared for therapy assignment (Test or Control Therapy). The envelope will be opened by the RA after baseline parameters meas

盲法

试验项目经费来源

General Research Fund, University Grant Council, HKSAR

试验范围

目标入组人数

实际入组人数

第一例入组时间

2016-07-01

试验终止时间

2018-06-30

是否属于一致性

入选标准

5.12.1. Inclusion Criteria 5.12.1.1. Chronic Periodontitis patients; 5.12.1.2. At least 1 tooth presented with 1 site with >5mm PPD and ≥6mm CAL, with ≥3mm intra-osseous defect presented on paralleling periapical radiographs; 5.12.1.3. Presence of at least one periodontally stable tooth with PPD≤3mm both anterior and posterior to the defined surgical site; 5.12.1.4. Good Oral Hygiene, with Full Mouth Plaque Score ≤30% at baseline and with good plaque control at proposed surgical field;；

排除标准

5.12.2. Exclusion Criteria 5.12.2.1. Pre-study period 5.12.2.1.1. Any systemic condition which prevents following the study protocol; 5.12.2.1.2. Any systemic condition which may affect healing outcomes of patients, e.g. uncontrolled or poorly controlled diabetes, unstable or life-threatening conditions or those requiring antibiotic prophylaxis; 5.12.2.1.3. Patients under long term analgesic medication; 5.12.2.1.4. Self-reported pregnancy; 5.12.2.1.5. Systemic antimicrobial therapy within 3 months; 5.12.2.1.6. Tooth with hopeless prognosis or questionable prognosis associated with endodontic lesions; 5.12.2.1.7. Any factors which prohibit regular performance of plaque control around surgical sites; 5.12.2.1.8. Inadequate oral hygiene with Full Mouth Plaque Score >30%；

研究者信息

研究负责人姓名

试验机构

Prince Philip Dental Hospital

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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