Dimensional Changes of Soft and Hard Tissues Following Alveolar Ridge Preservation: Freeze-dried Bone Allograft vs. L-PRF Clot Covered With d-PTFE Membrane: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Overall Horizontal Change in Alveolar Ridge Width
研究概览
简要总结
A Clinical Trial to study the effectiveness between two, tooth socket grafting materials namely, Freeze Dried Bone Allograft (human derived bone particles) and Leukocytic-Platelet Rich Fibrin (the patient's own centrifuged blood).
The purpose of this study is to compare the effects (good and bad) of Bone Allograft to Platelet Rich Fibrin to see which material would be the most effective in maintaining the volume of the gum and bone of the jaw during the healing phase as well as minimizing the amount of pain and/or swelling following tooth extraction.
详细描述
A prospective,randomized clinical trial will be conducted to determine whether L-PRF, compared to freeze dried bone allograft, will result in comparable volumetric shrinkage of the alveolar ridge and overlying keratinized tissue, following extraction of teeth and socket grafting.
This trial aims at obtaining information to determine which material would provide a superior clinical result, as well as reporting on patient related outcomes. The participants will be randomly assigned to two groups. The surgical procedure will be performed by one of five calibrated periodontal residents.
Patients will be followed for 2 weeks post-operatively by the same resident, to monitor the healing process and to assess for any complications.
Randomization will be achieved using a computerized randomization scheme and will be assigned to one of two groups and allocated by means of a sealed envelope opened on the day of surgery communicated to the surgeon during the surgery by a supervising faculty member. Participants will be block-randomized for each of the 5 operators for balance.
Anesthesia will be achieved and soft tissue measurements will be obtained using a periodontal probe. An atraumatic extraction technique will be performed to allow for minimal disturbance of the soft and hard tissue architecture.
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
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with molars or premolars indicated for extraction.
- •Patients that present with a post extraction class I and II socket (<30% bone loss on the buccal or lingual plate, measured from the most coronal aspect of intact bone to the most apical aspect of the defect divided by the measurement from the most apical aspect of the defect to the apex of the socket x 100).
- •Patients presenting with the need for single extractions.
- •Patients with general good health that does not have a condition contra-indicating routine dental treatment, extraction and implant placement.
- •Patients that are compliant with the research protocol and methods.
- •Patients that have read, understood and signed an informed consent form.
排除标准
- •Extraction and ridge preservation indicated for teeth other than premolars and molars.
- •Patients that present with a post extraction class III socket (>30% bone loss on the buccal or lingual plate, measured from the most coronal aspect of intact bone to the most apical aspect of the defect divided by the measurement from the most apical aspect of the defect to the apex of the socket x 100)
- •Patients deemed eligible for immediate implant placement following extraction and intra-operative assessment by the attending supervisor.
- •Patients that present with an oral-antral communication, post extraction.
- •Patients that presents with the need for multiple, side by side extractions.
- •Patients with coagulation disorders, on corticosteroids, uncontrolled diabetes mellitus, or any systemic disease where periodontal surgery is contraindicated and healing may be compromised.
- •Pregnant and nursing women.
- •Patients with any contact hypersensitivity to the related materials used in the study.
- •Heavy tobacco users, >10 cigarettes per day.
- •Patients unwilling to sign consent or follow the protocol of the study.
结局指标
主要结局
Overall Horizontal Change in Alveolar Ridge Width
时间窗: Difference reported on horizontal changes comparing CBCT analysis 11weeks after extraction and grafting compared to CBCT following extraction and grafting
Calculated mean of post operative CBCT measurements of horizontal alveolar bone width changes following extraction and alveolar ridge preservation.
次要结局
- Buccolingual Change in Width of Keratinized Soft Tissue(Soft tissue measurement at time of extraction and grafting and 12 weeks after extraction and grafting)
- Post-operative Pain and Swelling(Measured at 7 days following extraction and grafting)
研究者
Dr. Jonathan Bouwer
Periodontal Resident
University of Manitoba