跳至主要内容
临床试验/NCT06673446
NCT06673446撤回不适用

Soft Tissue Stability in the Esthetic Zone: A Randomized Clinical Trial Comparing Vestibular Socket Therapy With Contour Augmentation for Compromised Adjacent Sockets

British University In Egypt1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
32
试验地点
1
主要终点
Soft Tissue Stability

研究概览

简要总结

While early implant placement with guided bone regeneration (GBR) offers advantages, the desire for reduced treatment time and fewer surgical steps continues to drive the exploration of alternative approaches. In this context, the recent introduction of vestibular socket therapy (VST) presents an intriguing option. VST utilizes a minimally invasive tunnel access technique through the vestibular area to perform socket augmentation for immediate implant placement in compromised extraction sockets .

详细描述

The concept of immediate implant placement has been around for a while. Professor Wilfried Schulte conducted the first study on this technique in 1978, Extensive studies conducted over the past 40 years have demonstrated that immediate implant placement is a safe and effective method for restoring teeth that are badly destructed.

While immediate implant placement has been shown as a viable option, new studies using advanced imaging techniques (cone beam CT scans) reveal limitations in the front upper jaw (anterior maxilla).

  • Thin Bone Walls: These scans show that a thick bone wall, ideal for implant stability, is uncommon in this area. Only about 5% of patients have a thick wall (>1mm) in the central incisor region.
  • Facial Bone Defects: Another recent study found that over half (52%) of implant sites in the central incisor area have a missing facial bone wall (defect).

These findings highlight the main concerns with immediate implants in the front upper jaw:

  • Bone Instability: Thin bone and missing facial bone can lead to an unstable implant, especially in the thin tissue layer at the front of the jaw (labial plate).
  • Soft Tissue instability: An unstable implant can cause the gum tissue to recede, compromising the cosmetic outcome in this highly visible area.

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)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (20 to 50)
  • patients with two adjacent hopeless maxillary teeth or remaining roots in the esthetic region missing coronal tooth structure, type II socket (deficient labial plate of bone and intact overlying soft tissues), adequate palatal bone, ≥ 3 mm apical bone to engage the immediately placed implants, thereby achieving optimum primary stability (a minimum of 30 Ncm insertion torque) following teeth extraction.
  • acceptable compliance and oral hygiene.

排除标准

  • medically compromised patients. (Systemic diseases).
  • general contraindication for implant placement. (Untreated periodontitis, severe bruxism , immunosuppression , uncontrolled diabetes , smokers , patients under radiation therapy, patients on bisphosphonate medications).

结局指标

主要结局

Soft Tissue Stability

时间窗: 6 months

it will be measured digitally using the intraoral scanner. A preoperative scanning, immediate postoperative, 3 months postoperative and 6 months postoperative scanning will be done. Tool to be used: 3shape trios 4 what will be assessed: * gingival recession * loss of interdental papillae height Data will be measured in millimeters

次要结局

  • Bone Regeneration(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验