NCT07832565尚未招募不适用
Comparison of Dental Implant Placement With Simultaneous Sandwich Bone Augmentation vs. Mixed Bone Augmentation: a Randomized Controlled Pilot Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Horizontal Bone Gain (mm) Measured by Cone-Beam Computed Tomography (CBCT)
研究概览
简要总结
This study is being done to see which of two common grafting techniques-mixing two different grafting materials or layering two grafting materials-works better to augment bone volume next to your dental implant(s). We want to know which technique results in better bone augmentation.
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
- Double (Participant, 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
- •Minimum dentition of 20 permanent teeth
- •Single edentulous site at maxillary premolar, canine, lateral incisor, or central incisor
- •Adjacent teeth present with sufficient clearance for an implant crown
- •Ridge width between 4 mm and 7 mm at the edentulous site
排除标准
- •Systemic criteria:
- •Current heavy smokers (>10 cigarettes per day) or heavy smokers who quitted less than 1 year
- •Pregnancy or lactating mothers
- •Diseases of the immune system or any medical condition that may influence the treatment outcome (for examples uncontrolled diabetes (HbA1c >7), uncontrolled cardiovascular disease, neurologic or psychiatric disorders, systemic infections, history of radiation therapy in the head and neck area, current use of oral bisphosphonates for >3 years or history of IV bisphosphonates use, current alcoholism or drug abuse, etc.)
- •Intraoral criteria:
- •Acute infection at/or adjacent to the edentulous site (e.g., sinus tract, swelling, etc.)
- •Observable gingival changes due to use of medications such as calcium antagonists, anticonvulsives, immunosuppressants, anti-inflammatory medications, etc.)
- •Generalized uncontrolled dental diseases, e.g. caries, periodontal diseases, etc.
- •Uncontrolled periodontal disease
- •Poor oral hygiene (>20% plaque score)
- •CBCT criteria:
- •More than 7 mm of alveolar ridge with at the edentulous site present on CBCT scans
- •Intraoperative criteria:
- •An implant without primary stability >35N
研究组 & 干预措施
Sandwich bone augmentation
Experimental
干预措施: Sandwich bone augmentation (Procedure)
Mixed bone augmentation
Active Comparator
干预措施: Mixed bone augmentation (Procedure)
结局指标
主要结局
Horizontal Bone Gain (mm) Measured by Cone-Beam Computed Tomography (CBCT)
时间窗: 1 year after crown delivery
Horizontal bone gain will be measured in millimeters (mm) by comparing CBCT images obtained at baseline and follow-up. Measurements will be performed using computer-based imaging software to quantify changes in horizontal alveolar ridge width at the treated site.
次要结局
- Implant Survival Assessed by Clinical Examination(1 year after crown delivery)
- Pink Esthetic Score (PES) Assessed by a Blinded Examiner(1 year after crown delivery)
研究者
研究点 (1)
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