Efficacy and safety of locally produced polycaprolactone infiltrated porous nanohydroxyapatite and bilayered polycaprolactone membrane for bone augmentation in dental implant treatment: A Multicenter prospective single-blinded randomized controlled clinical study

Health Systems Research Institute (HSRI)0 个研究点目标入组 64 人开始时间: 2023年6月1日最近更新: 2024年8月19日

适应症

试验速览

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•1. Adult patients (age 20-65 years)
•2. Good general health (ASA 1, 2) and not a contraindication for minor surgery
•3. The diagnosis and indications for a particulate bone substitute are including:
•a. Alveolar bone defects, class 2.
•b. The edentulous area allows placement of at least one standard
•implant and not exceeded a two-tooth span.
•4. Patients who needed reconstruction of the edentulous sites with
•simultaneous implant placement
•5. Controlled periodontitis.
•6. Smoking history less than 10 cigarettes per day. For the subject who smokes but less
•than 10 cigarettes per day is requested to stop smoking two weeks before
•and after bone block graft surgery and implant placement
•7. No history of allergy or hypersensitivity to any of the materials to be used in

•1. Presence of relevant medical conditions: Patients with bone disease,
•osteoporosis, uncontrolled diabetes mellitus, unstable or life-threatening
•conditions, or requiring antibiotic prophylaxis. Patients with medication of drugs
•influencing the bone metabolism or use of bisphosphonates.
•2. Pregnancy or lactation.
•3. Patients with active infection or pathologic lesions prior to operation
•4. Patients who cannot take impression (both conventional and digital) and CBCT
•5. History of malignancy, radiotherapy, or chemotherapy for malignancy in the
•past 5 years.
•6. History of autoimmune disease or long-term prescribed of nonsteroidal antiinflammatory
•7. Unwillingness to return for the follow-up examination.

发起方

Health Systems Research Institute (HSRI)