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临床试验/NCT06358352
NCT06358352已完成不适用

Clinical and Radiographic Assessment of PRF Versus Lutein Placement Around Immediately Placed Dental Implants

Mansoura University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
bone formation

研究概览

简要总结

Thirty patients seeking for prosthetic replacement of non-restorable single rooted maxillary teeth by dental implant placement will be selected from the Out-Patient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.

Inclusion criteria: 1. Badly destructed maxillary single rooted teeth due to trauma or caries. 2. Age between 20 and 45 years. 3. Good oral hygiene. 4. Patients willing to complete the study follow up intervals. 5. Patients will be informed about the aim of the study and a written consent will be obtained. The patients have the right to withdraw from the study at any time.

Exclusion criteria: 1. periapical infection in the teeth to be replaced. 2. Alcohol or drug abuse. 3. Patients with systemic diseases that absolutely contraindicate implant placement 4. Pregnancy. 5. Patients with parafunctional habits (bruxism and clenching) 6. Uncooperative patients 7. Heavy smokers.

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Patients grouping: Patients will be randomly divided into three groups:

Group A: Immediate implant placement with leaving the gap distance empty

Group B: Immediate implant placement then placement of PRF around the implant in the gap distance

Group C: Immediate implant placement then placement of lutein around the implant in the gap distance

Clinical evaluation:

Patients will be evaluated clinically for:

1-Postoperative Pain: By using a 10-point Visual Analogue Scale (VAS) for assessment of pain by the patient on the 1st, 3rd, and 7th days after surgery.(10) (0-1=None, 2-4=Mild, 5-7=Moderate, 8-10=Severe) 2. Implant stability Will be assessed at the time of implant insertion and at a period of 3, 6 and 12 months intervals. Resonance frequency analysis (RFA) values expressed as implant stability quotient (ISQ) will be recorded by a transducer attached to the implant by a screw and a frequency response analyzer (Osstell Mentor Device) with the average of 2 measurements performed with the probe in 2 perpendicular directions.

  1. Sulcus Bleeding Index (SBI) An early sign of gingivitis is bleeding on probing and, in 1971, Muhlemann and Son described the Sulcus Bleeding Index (SBI). It will be assessed at 3, 6 and 12 months intervals.

  2. Peri-implant probing depth: Depth of the peri-implant sulcus will be made at 3, 6 and 12 months intervals with light force to avoid undue tissue damage and over-extension into the healthy tissue.

Radiographic evaluation:

conebeam CT will be done to evaluate the vertical and horizontal changes to the alveolar bone following immediate implant placement. It will be done immediately after implant placement , after 3 months and after 12 months

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Badly destructed maxillary single rooted teeth due to trauma or caries.
  • Age between 20 and 45 years.
  • Good oral hygiene.
  • Patients willing to complete the study follow up intervals.
  • Patients will be informed about the aim of the study and a written consent will be obtained. The patients have the right to withdraw from the study at any time.

排除标准

  • periapical infection in the teeth to be replaced.
  • Alcohol or drug abuse.
  • Patients with systemic diseases that absolutely contraindicate implant placement
  • Patients with parafunctional habits (bruxism and clenching)
  • Uncooperative patients
  • Heavy smokers.

结局指标

主要结局

bone formation

时间窗: 12 months

bone formation will be assessed by using conebeam CT

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fakhreldin Hassan Abdel-Rahman

assistant professor of oral and maxillofacial surgery

Mansoura University

研究点 (2)

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