Effect of Two Different Incision Techniques on Soft and Hard Tissue Outcomes in Immediate Implant Placement in Class II Extraction Sockets of the Esthetic Zone: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pink Esthetic Score (PES)
研究概览
简要总结
This randomized controlled clinical trial investigates the effect of two different surgical approaches-Vestibular Socket Therapy (VST) and Flap Elevation Technique-on soft and hard tissue outcomes during immediate implant placement in Class II extraction sockets of the anterior maxilla (esthetic zone). The study enrolled 26 systemically healthy adult patients contributing a total of 48 surgical sites. Each site was randomly assigned to one of the two treatment groups.
The VST group employed a minimally invasive vestibular incision to allow atraumatic extraction, implant placement, bone grafting, and membrane placement while preserving the labial soft tissue and periosteal blood supply. The Flap Elevation group followed a conventional intrasulcular flap approach. In both groups, implants were placed with 30 Ncm torque and augmented with MegaOss™ allograft and a resorbable collagen membrane (T-barrier™).
Clinical and radiographic evaluations were conducted at baseline, 6 months, and 12 months post-loading. Outcomes measured included Pink Esthetic Score (PES), peri-implant probing depth (PD), mucosal level changes, and crestal bone level changes.
详细描述
Tooth extraction in the anterior maxilla, particularly in the esthetic zone, often leads to substantial resorption of the alveolar ridge, predominantly affecting the thin buccal bone plate. Studies have shown that up to 50% of horizontal ridge width can be lost within 6 months of extraction, compromising both soft tissue contours and the feasibility of future implant placement (Araújo & Lindhe, 2005; Schropp, Wenzel, Kostopoulos, & Karring, 2003). This resorption has profound esthetic and functional implications, especially in patients with high smile lines or thin periodontal biotypes.
To address these challenges, immediate implant placement was introduced to reduce treatment time, preserve socket dimensions, and optimize soft tissue outcomes (Kan, Rungcharassaeng, Umezu, & Kois, 2003; Lang, Pun, Lau, Li, & Wong, 2012). While immediate implants help maintain the overall ridge profile, they do not fully prevent bone remodeling of the buccal plate, which often results in soft tissue recession and compromised esthetic outcomes (Botticelli, Berglundh, Buser, & Lindhe, 2003; Chen & Buser, 2014).
Flap design during implant surgery has been identified as a critical factor influencing peri-implant bone and soft tissue healing. The traditional flap elevation approach provides good visibility but disrupts the periosteal blood supply, increasing the risk of bone resorption and soft tissue shrinkage (Fickl et al., 2008; Jeong et al., 2007). By contrast, flapless surgery preserves the periosteal blood supply and minimizes soft tissue trauma, leading to superior bone preservation and reduced postoperative discomfort (Becker, Goldstein, Becker, & Sennerby, 2005; Oh, Shotwell, Billy, & Wang, 2006). However, flapless techniques carry limitations such as reduced access and increased risk of malpositioning the implant or causing thermal bone damage without adequate irrigation (Choudhary et al., 2023).
To overcome the limitations of both approaches, Vestibular Socket Therapy (VST) was developed as a minimally invasive technique that allows simultaneous atraumatic extraction, implant placement, and socket augmentation through a small vestibular access incision (A. Elaskary et al., 2023). VST preserves the integrity of the labial soft tissues and periosteal blood supply, improves labial bone support, and enables simultaneous use of bone grafts and membranes to enhance both hard and soft tissue outcomes (Ghallab et al., 2023). Clinical trials comparing VST to conventional incisal extraction or partial extraction therapy (PET) have demonstrated comparable or superior outcomes in terms of Pink Esthetic Score (PES), soft tissue volume preservation, and facial bone thickness (A. Elaskary et al., 2023; Hamed et al., 2023).
Bone grafting materials used in combination with immediate implants have also been extensively studied. While autogenous bone has been considered the gold standard, it is often limited by donor site morbidity. Alternatives such as deproteinized bovine bone mineral (DBBM), demineralized bone matrix (DBM), and collagen plugs have been successfully used to fill peri-implant defects and support labial bone regeneration (Araújo & Lindhe, 2005; Artzi, Tal, & Dayan, 2000; Jensen & Terheyden, 2009). Randomized controlled trials have shown that using a combination of autogenous bone chips with DBBM (e.g., MinerOss X) significantly increases facial bone thickness compared to collagen plug or DBM alone (Hamed et al., 2023).
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 (Outcomes Assessor)
盲法说明
The study employed single masking, where the clinical outcome assessors, radiographic evaluators, and statisticians were blinded to group assignments. The operating surgeon was not blinded due to the nature of the surgical procedures. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes.
入排标准
- 年龄范围
- 20 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 20 to 50 years.
- •Presence of one or more non-restorable or remaining roots in the maxillary anterior region (canine to canine).
- •Class II extraction sockets confirmed by CBCT.
- •Sufficient apical and palatal bone to ensure proper implant positioning and primary stability.
- •Good compliance with treatment visits and oral hygiene.
- •Medically healthy with no systemic diseases affecting wound healing or implant success.
排除标准
- •Systemic conditions that contraindicate implant or periodontal surgery (e.g., immunocompromised, uncontrolled systemic disease).
- •Smokers, diabetics, or pregnant/lactating women.
- •History of chemotherapy or radiotherapy in the head and/or neck region.
- •Patients on bisphosphonate therapy.
- •Presence of acute infection at the intended implant site.
研究组 & 干预措施
Vestibular Socket Therapy (VST) Group
Participants in this group underwent immediate implant placement using Vestibular Socket Therapy (VST). A minimally invasive vestibular incision was made, followed by atraumatic extraction, implant placement (BioHorizons, 30 Ncm), bone grafting with MegaOss™ allograft, and placement of a T-barrier™ collagen membrane. The membrane was stabilized with tacks, and the site was closed with 7/0 nylon sutures. Healing was supported by customized composite healing abutments, and final zirconia crowns were delivered at 3 months.
干预措施: Vestibular Socket Therapy (VST) Group (Procedure)
Flap Elevation Group
Participants in this group received immediate implant placement using a conventional mucoperiosteal flap elevation approach. After intrasulcular and vertical incisions, atraumatic extraction was followed by implant placement (BioHorizons, 30 Ncm), grafting with MegaOss™ allograft, and coverage with a T-barrier™ collagen membrane, stabilized with tacks. The site was closed with 7/0 nylon sutures, and healing was supported with customized composite healing abutments. Final zirconia crowns were placed at 3 months.
干预措施: Flap Elevation Group (Procedure)
结局指标
主要结局
Pink Esthetic Score (PES)
时间窗: 6 and 12 months after prosthetic crown delivery
The Pink Esthetic Score (PES) evaluates seven soft tissue parameters around implants: mesial papilla, distal papilla, soft tissue level, contour, alveolar process deficiency, tissue color, and texture. Each parameter is scored from 0 (poor) to 2 (ideal), with a total possible score of 14. Higher scores reflect better esthetic outcomes.
次要结局
- Peri-Implant Probing Depth (PD)(6 and 12 months after prosthetic crown delivery)
- Peri-Implant Mucosal Level Changes(6 and 12 months after prosthetic crown delivery)
- Crestal Bone Level Changes(6 and 12 months after prosthetic crown delivery)
研究者
Fatma ElSayed
assistant professor
Ain Shams University
