Hard and Soft Tissue Dimensional Change After Consecutive Extractions and Unassisted Socket Healing in the Esthetic Zone: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Bone level change from baseline
研究概览
简要总结
The goal of this observational study is to evaluate the post-extraction hard and soft tissue dimension changes in patients requiring consecutive extractions and unassisted socket healing in the anterior maxilla. The main questions it aims to answer are:
- Is significant alveolar ridge resorption observed at center sites after consecutive extractions
- Is significant alveolar ridge resorption observed at the interalveolar septum after consecutive extractions, are different extraction sites associated with significantly different bone resorption
- Is a thick or thin wall phenotype associated with the amount of bone resorption
- Is soft tissue thickness change associated with the corresponding location (extraction site or interalveolar septum) and post-extraction thickness of the bone
- Is the interdental papilla height significantly affected after extractions.
Participants will undergo consecutive (two) extractions and will be evaluated after subsequent unassisted socket healing for 8 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18+ years old
- •Require consecutive (two) teeth replacement in the anterior maxilla
- •Signed informed consent
- •No significant medical conditions
- •Patients with healthy periodontal conditions or previously treated to controlled and stable conditions
排除标准
- •General medical (American Society of Anesthesiologists, ASA, class III or IV) and/or psychiatric contraindications
- •Pregnancy or nursing
- •Any interfering medication such as steroid therapy or bisphosphonate therapy
- •Uncontrolled diabetes
- •Autoimmune diseases or inflammatory diseases affecting the intraoral tissues
- •Radiation therapy to head or neck region
结局指标
主要结局
Bone level change from baseline
时间窗: Baseline and at 8 weeks
Measured in millimeters using segmented surface model superimpositions. Changes in bone loss between baseline and an 8 week healing period using CBCT. From the Digital Imaging and Communications in Medicine (DICOM) files two surface mesh models were generated, which were superimposed and the changes were subsequently analyzed.
Soft tissue change from baseline
时间窗: Baseline and at 8 weeks
Changes in soft tissue loss at baseline and 8 weeks were analyzed using digital dental impressions acquired from intraoral scans, which were superimposed and the changes were analyzed.
次要结局
- Correlation between baseline facial bone thickness and dimensional soft tissue alterations during healing at the interalveolar septum.(Baseline and at 8 weeks)