Effect of Albumin Gel-platelet-rich Fibrin (Alb-PRF) and Advanced Platelet-rich Fibrin (A-PRF) in Alveolar Ridge Preservation in Diabetes Patients - A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 主要终点
- Ridge horizontal width
研究概览
简要总结
This study aim to investigate the effect of albumin gel- and platelet- rich fibrin(Alb-PRF) combined with advanced platelet-rich fibrin (A-PRF) on alveolar ridge preservation by comparing alveolar ridge morphometric changes (hard and soft tissue), prospects and treatment complexity for placement of prosthetically guided dental implant, early oral wound healing outcomes evaluated by the Inflammatory Proliferative Remodeling Scale, and patient reported outcome measures, in Type I/II Diabetes Mellitus patient, versus spontaneous healing
详细描述
Diabetes is a well-established risk factor for oral diseases that often lead to extractions and tooth loss in the population, while diabetic patients also have increased susceptibility to wound infections.
Albumin gel-platelet-rich fibrin (Alb-PRF) and advanced platelet-rich fibrin (A-PRF) are third-generation of platelet concentrates derived from a donor's blood by following a simple centrifugation protocol, heat treatment of platelet-poor plasma, and mixing of liquid-PRF from the same preparation.
This study proposes a novel alveolar ridge preservation technique based on the application of A-PRF inside the extraction socket to sustain the release of growth factors during the early wound healing phase, together with periosteum inhibition by overlaying an Alb-PRF membrane with slow biodegradation and space maintenance properties over the bone to reduce post-extraction alveolar ridge resorption.
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)
盲法说明
Participlant will be masked Care provider and investigator could not be masked due to the intrinsic nature of the intervention, however the allocation will be concealed until the extraction of teeth is completed.
Outcome assessor will be masked
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
- 未提供
排除标准
- •i. Patients with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability.
- •ii. Pregnancy or intention to become pregnant at any point during the study duration.
- •iii. Smoker /alcoholic iv. Has platelet dysfunction/ thrombocytopenia/ blood dyscrasia v. On bisphosphonates or drugs that will significantly alter bone metabolism. vi. ASA III/IV.
结局指标
主要结局
Ridge horizontal width
时间窗: Up to 20 weeks
Ridge horizontal width changes (1mm, 3mm, 5mm apical to most coronal crest at buccal/oral) Method: CBCT
次要结局
- Cytokines and growth factors(Up to 56 days)
- Implant planning related outcome(Up to 20 weeks)
- Histological assessment(Up to 24 weeks)
- Keratinized tissue width changes(Up to 20 weeks)
- Patient-reported outcome measures(Up to 28 days)
- Ridge volume and profile(Up to 20 weeks)
- Ridge height(Up to 20 weeks)
- Inflammatory proliferative remodelling(Up to 28 days)
研究者
Dr. Melissa Fok
Clinical Assistant Professor
The University of Hong Kong