18983288589(微信同号)
18983288589(微信同号)
18908392210(微信同号)
18980413049
ChiCTR-INR-16008407
尚未开始
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2016-05-03
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Periodontal disease
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
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
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.
随机平行对照
治疗新技术
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
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General Research Fund, University Grant Council, HKSAR
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22
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2016-07-01
2018-06-30
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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;;
登录查看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%;
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