Efficacy of Enamel Matrix Derivatives Adjunctive to Closed-apex Teeth Autotransplantation A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Clinical Attachment Level
研究概览
简要总结
The goal of this randomized clinical trial is to compare the adjunctive use of enamel matrix derivatives in the treatment of tooth autotransplantation in terms of clinical attachment level. The main question it aims to answer. What is the benefit, in terms of clinical attachment level and probing depths, of using enamel matrix derivatives adjunctive to tooth autotransplantation? Participants will be subjected to a digitally guided surgery of tooth autotransplantation. The protocol of the test group will be supplemented with the application of enamel matrix derivatives before the placement of the transplanted tooth into the surgically produced alveolus.
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
- 是
入选标准
- •Adult patients attending the University Complutense of Madrid for dental treatment were eligible to participate in the study if they met the following criteria:
- •adults (≥18 years old) capable of providing informed consent, teeth deemed-unrestorable in need of replacement
- •presence of a viable, healthy, periodontally stable, and nonfunctional tooth (e.g., third molar) suitable for autotransplantation
- •periodontally healthy individuals or those with stable periodontal conditions after periodontal therapy.
排除标准
- •clinical attachment loss of the donor teeth (CAL less 6 mm)
- •compromised general health or patients with systemic diseases that could influence the therapy outcome (uncontrolled diabetes mellitus, bone disorders, etc.)
- •pregnant or nursing women
- •chronic use of corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or immune-modulator drugs
- •patients requiring medications that affect bone metabolism (bisphosphonates
- •chronic oral mucosa diseases
- •evident signs of severe bruxism or clenching habits
- •smokers of more than 10 cigarettes per day
- •non-compliant patients with 25% plaque index at the time of re-evaluation after non-surgical periodontal therapy and oral hygiene instructions
- •patients unable to attend study-related procedures and follow-up visits
结局指标
主要结局
Clinical Attachment Level
时间窗: through study completion, an average of 1 year
measured as the distance in mm from the CEJ to the bottom of the pocket will be the primary outcome of this study.
次要结局
- Digital image assessment. Position of the Alveolar Ridge Measurements(at the study completion. an average of 1 year)
- Radiographic bone level(through study completion, an average of 1 year)
研究者
Ignacio Pedrinaci Peñalver
Principal investigator
Universidad Complutense de Madrid