Assessment of Soft Tissue Thickness Following Utilization of Buccal Pad of Fat Versus Platelet-rich Fibrin for Covering Zygomatic Implants: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The peri-implant soft tissue thickness
研究概览
简要总结
Would buccal pad of fat be comparable to platelet rich fibrin for Zygomatic implant coverage as a step for reconstruction of atrophic posterior maxilla, in terms of peri-implant soft tissue thickness and avoiding complicated postoperative sequalae?
详细描述
This study aims to assess whether the buccal fat pad might prevent mucosal dehiscence and avoid potential postoperative complications when buccal fat pad is used to cover the body part of the zygomatic implants compared to the platelet rich fibrin during the reconstruction of atrophic maxilla. The expected benefit from the current study is to select the most suitable coverage for Zygomatic implant placement with the least postoperative complications also providing an appropriate soft tissue profile during the immediate loading phase preparing it for the final restoration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severely atrophic edentulous upper arch (Cawood class IV, V, VI) that could not be restored by other type of treatment
- •Patients who had at least 8-12 mm vertical bone height in anterior maxilla to allow installation of 2 conventional implants.
- •Lacking posterior maxillary bone support due to significant sinus pneumatization
- •Good systemic health (ASA score I-II)
- •Highly motivated patients
排除标准
- •Patient not willing to give his/her informed consent.
- •Patients with systemic disease that did not permit the surgical procedure (including general anesthesia).
- •Patients with uncontrolled diabetes or under bisphosphonate therapy.
- •Heavy smoker. (> 20 cigarettes daily)
- •Patient with psychiatric problems, severe bruxism or other parafunctional habits.
- •Acute sinusitis.
- •Malignancy or pathology in Maxilla or Zygoma.
研究组 & 干预措施
Coverage with PRF for Zygomatic implant placed
PRF preparation and placement: Shortly before being positioned at the surgical site, the PRF was freshly prepared. Ten milliliters of blood were extracted from the antecubital vein and put into a test tube devoid of anticoagulant for the PRF preparation. The blood sample was centrifuged right away for 10-12 minutes at 3000 rpm. The PRF membrane was obtained by squeezing the fibrin clot between pieces of gauze after centrifugation
干预措施: Coverage with PRF for Zygomatic implant placed (Biological)
Coverage with buccal fat pad for Zygomatic implant placed
Broad muco-periosteal dissection of the anterior maxilla and its lateral sides can easily be used to make an incision of the periosteum in the area of the wisdom teeth during implant insertion. The buccal fat pad will be dissected into the oral cavity after being enlarged with scissors. The pad can be moved forward and lower to cover the implants by gently pulling it with an atraumatic clamp. Resorbable sutures are then used to secure it to the palatal mucosa, The flap will be repositioned over the BPF and sutured to the palatine mucosa. The posterior implant typically has the easiest time achieving implant coverage.
To prevent premature traction, the dissection must be done very carefully. The pad must be gradually released from its capsule in order to complete the task. It is not problematic if there are pieces of the fat pad along the crestal suture. After surgery, this will turn into the epidermis in a few days.
The buccal fat pad going to be repositioned over implant body
干预措施: Coverage with PRF for Zygomatic implant placed (Biological)
结局指标
主要结局
The peri-implant soft tissue thickness
时间窗: Clinical evaluation will be performed at the operation day, 72 hours, 1st week, 15 days, 1month, 4-month intervals will be the first assessment for the soft tissue thickness then at 6 months and 12 months interval.
The peri-implant soft tissue thickness using the average of three measurement points on the buccal side of the implant platform registered with a periodontal probe (HH12 periodontal probe, Deppeler SA)
次要结局
- Postoperative complications(Clinical evaluation will be performed at the operation day, 72 hours, 1st week, 15 days, 1month, 4-month intervals will be the first assessment for the soft tissue thickness and postoperative complications then at 6 months and 12 months interval.)
研究者
Caroline John George
principal investigator
Cairo University