Efficacy of Digitally Tooth Autotransplantation With Adjunctive Use of Enamel Matrix Derivatives (EMD): A Prospective Case Series
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Clinical attachment level (CAL)
研究概览
简要总结
The goal of this prospective case series 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 is:
- What is the benefit, in terms of clinical attachment level, of using enamel matrix derivatives adjunctive to tooth autotransplantation?
Participants will be subjected to a digitally protocol of tooth autotransplantation.Only one group (test) is assessed. It will be supplemented with the application of enamel matrix derivatives before the placement of the transplanted tooth into the surgically produced alveolus.
详细描述
All surgical treatments will be performed by the same experienced periodontist (IP) after the administration of local anesthesia. Initially, tooth sectioning of the hopeless tooth (receptor) will be carried out using fissure carbide burs, and the remaining fragments will be extracted as minimally invasively as possible. A tooth-supported surgical guide will be used to prepare the recipient site following the 3D planning. Additional alveoloplasty procedures will be performed with round diamond burs if necessary to adapt the computed aid rapid prototyping (CARP) model to the virtual planning position. The donor tooth will be extracted as atraumatically as possible, utilizing a piezoelectric surgical instrument if osteotomy is required, and avoiding the use of elevators or forceps over the root surface. Extraorally, EMD will be applied to the root surface of the donor tooth.
After positioning the donor tooth onto the surgically created recipient bed, a semi-rigid orthodontic wire will be used to splint the tooth to the mesial and distal adjacent teeth, and sutures will be applied to closely adapt the soft tissues around the autotransplanted tooth. Occlusal adjustments will be made if necessary. Alternatively, orthodontic composite bite stops will be placed on top of adjacent teeth to obtain temporary dental disocclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •adults (≥18 years old) capable of providing informed consent, teeth deemed unrestorable and 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
- •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 (CAL)
时间窗: through study completion, an average of 1 year
CAL level changes on the donor tooth between the baseline situation and the last follow up visit.
次要结局
未报告次要终点
研究者
Ignacio Pedrinaci Peñalver
Dr. Principal investigator
Universidad Complutense de Madrid