Clinical and Radiographic Evaluation of Doxycycline and Doxycycline Loaded Nanoparticles With Gelatin Sponge on Immediate Implant Placement in Esthetic Zone: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Marginal (crestal) bone loss (MBL).
研究概览
简要总结
The goal of this clinical trial is to Evaluate the effect of Doxycycline nanoparticles along with gelatin sponge in immediate implant cases in esthetic zone. The main question it aims to answer is:
Does the application of doxycycline nanoparticles with gelatin sponge improve the clinical and radiographic outcomes of immediate implant cases in esthetic zone?
Researchers will compare eight patients undergoing immediate implant placement with the buccal gap filled with doxycycline loaded gelatin nanoparticles along with gelatin sponge (group A) with eight patients undergoing immediate implant placement with the buccal gap filled with doxycycline along with gelatin sponge (group B). to see if the doxycycline loaded nanoparticles will improve the clinical and radiographic outcomes of the immediate implant .
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The presence of non-restorable single-rooted maxillary centrals, canines or premolars.
- •Sufficient bone volume.
- •Good oral hygiene.
- •The remaining space between the socket and the fixture equals or more than 2mm at the coronal third of the socket.
- •Sufficient bone width (≥ 1 mm) in the buccal plate of the remaining bone to place an implant confirmed by cone beam computer tomography (CBCT).
排除标准
- •Insufficient bone volume.
- •Active infection.
- •Patients on chemotherapy or radiotherapy.
- •Patients who have systemic disorders {uncontrolled diabetes mellitus, autoimmune disease, ...etc},
- •Pregnant patients,
- •Patients with bone diseases
- •Presence of periapical pathology affecting the neighbouring teeth.
研究组 & 干预措施
immediate implant placement with doxycycline loaded gelatin nano particles and gelatin sponge
干预措施: Immediate Implant Placement (Procedure)
Immediate Implant Placement with Doxycyline and Gelatin Sponge
干预措施: Immediate Implant Placement (Procedure)
结局指标
主要结局
Marginal (crestal) bone loss (MBL).
时间窗: after surgery and 6 months after surgery
Radiographic examination of the patients will be done firstly pre-operative then just after the surgical procedures as a base point and at six months follow-up period post-operative by using CBCT (carestream 9600). On Demand3D program will be used for image reconstruction and analysis. For the calculation of marginal (crestal) bone loss (MBL), the implant will be used as a reference by adjusting the cross-sectional long axis in the center of the implant and bisecting it. A line will be drawn parallel to the implant, starting at the crest of the bony cortical plate of bone and ending at the apical level of the implant; height will be recorded in millimeters immediately and 6 months postoperative. The same process will be repeated from the palatal direction.
次要结局
- Pink Esthetic Score(before the surgery, 3 months and 6 months after the surgery)
- Peri-Implant Periodontal Probing depth (PPD):(3 months and 6 months after the surgery)
- Peri-implant vertical bone level.(after surgery and 6 months after surgery)
- Implant stability(at the time of surgery, 3 months and 6 months post surgery)
研究者
Ahmed Othman Fathy Othman El-Kersh
demonstrator of Department of Periodontology, Oral Diagnosis and Oral Radiology at Faculty of Dentistry, Kafrelsheikh university
Kafrelsheikh University