Evaluation of the Effectiveness of ALB-PRF With Two Types of Bone Grafts With Putty Form in the Treatment of Peri-Implant Bony Defects Around Immediate Dental Implants in the Maxillary Aesthetic Zone.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- soft tissue healing. in relation to different membrane and putty form bone
研究概览
简要总结
The goals of this clinical trial study is to evaluate the additive effect, of using ALB-PRF membrane combined with two different types of bone grafts with putty form in treatment of peri-implant bony defects around immediate dental implant within the maxillary esthetic zone.
Researchers will compare the ALB- PRF membrane extracted from patient blood with synthetic collagen membrane in addition to the putty form bone graft The main questions it aims to answer are:
Is the ALB-PRF is considered suitable alternative to synthetic collagen membrane in GBR techniques? also, growth factors releasing form ALB-PRF can continue over 21 days.
Participants will:
receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen as membrane. Also, in other hand participant will receive immediate implant with beta-tricalcium phosphate + calcium sulphate as bone graft and collagen as membrane. and compered with participants receive the same bone and implant technique except for ALB-PRF membrane instead of collagen.
详细描述
I) Patient selection Participants will be selected from the outpatient clinic in the Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University. All patients will be informed regarding the study nature of the surgical procedures, time of treatment, benefits, the suspected risk or complications and follow-up schedule visits and requested to sign a written consent. This study will be performed after getting approval by the ethics committee of the Faculty of Dentistry at Mansoura University.(A02090230M)
Inclusion criteria:
- Patient between 20-40 years old.
- Unrestorable maxillary tooth/ teeth in the aesthetic zone.
- Adequate keratinized soft tissue.
- Favorable pattern of occlusion.
- Good oral hygiene.
- Patient ability to comply with the required recall visits.
- Patients with type II socket.
Exclusion Criteria:
- Local or systemic diseases that contraindicate implant placement or surgery.
- Smokers
- Patients with parafunctional habits.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Patient between 20-40 years old.
- •Unrestorable maxillary tooth/ teeth in the aesthetic zone.
- •Adequate keratinized soft tissue.
- •Favorable pattern of occlusion.
- •Good oral hygiene.
- •Patient ability to comply with the required recall visits.
- •Patients with type II socket.
排除标准
- •Local or systemic diseases that contraindicate implant placement or surgery.
- •Patients with parafunctional habits.
结局指标
主要结局
soft tissue healing. in relation to different membrane and putty form bone
时间窗: clinical parameters will be reassessed at plate will be measured at baseline, 6 months and 12 months postoperative.
Evaluate if the ALB-PRF membrane in combination with the two tested putty form bone graft materials play a role in acceleration of soft tissues healing. assessment of soft tissue healing which evaluated according to pink esthetic score (PES). The pink esthetic score evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14
Hard tissue healing .
时间窗: baseline, 6 months and 12 months postoperative
Hard tissue healing evaluation; Using cone beam CT (CBCT) scan, the changes in the marginal bone level and the thickness of buccal plate will be measured at baseline, 6 months and 12 months postoperative. CBCT will be evaluated and assessed by subtraction methods to notice the gained and loosed bone in millimeters.
次要结局
- Peri-implant pocket depth(baseline, 6 months and 12 months postoperative.)
- Implant stability evaluation(baseline, 6 months , and 12 months postoperative)
- Modified bleeding index(baseline, 6 months , and 12 months postoperative)
- growth factors concentration(one, two, four, and eight weeks postoperatively)
研究者
Hamzah Abdulatef Mansoor
B.D.S, M.S, Master Degree of Oral Medicine & Periodontology
Mansoura University