Soft Tissue Stability in the Esthetic Zone: A Randomized Clinical Trial Comparing Vestibular Socket Therapy With Contour Augmentation for Compromised Adjacent Sockets
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
- 是
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).
研究组 & 干预措施
control group (contour augmentation
Teeth extraction : minimally invasive adjacent teeth extraction under anesthesia using periotome and forceps.
the empty sockets will be filled with a special collagen material (BioPlug) to aid healing for 4 to 8 weeks.
flap elevation : a full-thickness flap will be carefully raised using a crestal incision extended one tooth mesial and distal to the extraction location, then connected with two vertical incisions extended through the sulcus forming a trapezoid flap.
Implants Insertion: The two implant is then placed into the prepared sockets using surgical guide.
Bone Grafting: Any bone deficiencies are addressed by grafting. This involves placing a layer of (autogenous bone) directly on the two implants' surface, followed by a layer of a bone-grafting material (Demineralized Bone Matrix).
Membrane Placement: A double-layered collagen membrane is used to cover the grafted area.
Flap Closure: The previously lifted flap is repositioned and sutured back in place.
干预措施: vestibular socket therapy (Procedure)
study group (VST)
- Access and Socket Preparation:
- A small incision (1 cm) is made on (vestibular area) near the base of the extracted teeth, extending slightly towards neighboring teeth. This creates a pouch for accessing the socket and surrounding bone.
- Using special instruments from the VST kit.
- Immediate Implant Placement with Guide:
* A prefabricated surgical guide ensures precise positioning of the implants directly into the socket. 3. Bone Grafting and Membrane:
* A mixture of bone chips harvested from the surgical site (autogenous bone) and a bone-grafting material (deproteinized bovine bone mineral) is used to fill any gaps and support the implant, especially in the labial bone wall (labial plate). 4. Closure and Healing:
- The small incision is stitched closed with sutures.
- A temporary healing cap is placed on the implants to facilitate proper healing.
干预措施: vestibular socket therapy (Procedure)
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)