Peri-implant Tissue Changes Using Dual Zone Concept with Connective Tissue Graft Versus Concentrated Growth Factor (A Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Volumetric analysis
研究概览
简要总结
Tooth extraction not only alters the bony architecture of the alveolar ridge, but it also has an impact on the surrounding soft tissues. Post-extraction recovery of both hard and soft tissues occurs uneventfully, resulting in horizontal and vertical tissue loss, affecting prosthetic rehabilitation with dental implants or tooth-supported prosthesis.
Aim of the study:
The aim of this study is to evaluate volumetric soft tissue alterations as well as clinical, radiographic, and esthetic outcomes in dual zone technique (DZ) using CTG (Connective Tissue Graft) versus CGF (Concentrated Growth Factor) Graft following maxillary IIP (Immediate Implant Placement) in the esthetic zone.
Materials and methods:
20 patients with hopeless teeth requiring extraction in maxillary esthetic zone and requiring replacement with dental implants, will be enrolled and recruited from the outpatient clinic, faculty of dentistry, Ain Shams University according to the inclusion criteria. They will be randomly allocated into two equal groups. Group I (n=17) immediate implant placement with dual zone technique using concentrated growth factor graft and group II (n=17) immediate implant placement with dual zone technique using connective tissue graft. Pink esthetic score (PES) was measured 6 months after the final crown placement. At the respective times radiographic CBCT measurements, volumetric analysis, and clinical measurements will be taken. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed. Data collected will be tabulated and statistically analyzed.
详细描述
Maintaining the natural esthetic appearance, particularly in the esthetic zone, together with the volume and contour of the soft tissue in harmony with the surrounding teeth soft tissue, is believed to be critical. However, postponing implant placement until hard and soft tissues have fully healed usually necessitates additional surgical intervention steps, such as guided bone regeneration or ridge splitting, or implant placement in undesirable positions with a low esthetic appearance to overcome alveolar ridge resorption.
In clinical practice, immediate implant placement (IIP) in the esthetic zone has been regarded as an ongoing concern. Immediate implant placement (IIP) aims to minimize the duration of therapy overall, cost-effectiveness, and patient aesthetic expectations. However, the physician needs to be aware of potential risks and undesirable effects associated with this surgery, such as early implant loss and dimensional alterations in soft and hard tissues. Clinical research continues to advance to improve predictability and minimize the occurrence of undesirable consequences following IIP due to evolving patients' esthetic demands and expectations.
Over the years, numerous surgical techniques have been proposed to preserve the soft and hard tissues in the esthetic zone. These techniques include proper 3D implant positioning, flapless approach, the addition of bone graft, the use of grafts containing growth factors such as concentrated growth factor (CGF) and platelet-rich fibrin (PRF) membranes, the application of connective tissue grafts (CTG), the socket shield technique, or the use of customized healing abutments. In order to offset the peri-implant tissue reduction, various treatments were also devised, including vestibular socket therapy, the dual-zone concept (DZ), and immediate dentoalveolar restoration.
From the above-mentioned approaches, Dual Zone technique was utilized in conjunction with CTG, and CGF graft were primarily advised for peri-implant soft tissue phenotypic preservation, stability, and health. The dual-zone (DZ) concept was developed to reduce the amount of buccal contour change at the extraction site while enhancing the thickness of the peri- implant soft tissues by filling the buccal gap with bone graft in two zones: the bone zone up to the crest of the socket bone and the soft tissue zone. To illustrate, graft particles are absorbed into tissues, increasing their thickness while also providing stability and maintaining soft tissue volume. As a result, the DZ concept aims to maintain the gingival contour while providing excellent soft tissue esthetics.
Connective tissue graft (CTG) and concentrated growth factor (CGF) graft are two commonly used materials for soft tissue augmentation in implant dentistry. CTG has a long history of success in improving soft tissue volume and quality around dental implants by forming a scaffold for cell migration and tissue regeneration. On the other hand, CGF, a newer autologous platelet concentrate rich in growth factors, has demonstrated promising results in stimulating tissue healing and regeneration, potentially outperforming standard graft materials.
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)
盲法说明
Patients will be blinded to the type of the intervention and the whole-time frame of the study will be 6 months.
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
- •Systemically (medically) free individuals were recruited for the present study according to the modified Burkett's health history questionnaire, ASA.
- •Males and females with age range 20 -
- •Patients having a history of hopeless tooth in esthetic zone (Anteriors/Premolars) indicated for extraction and immediate implant placement.
- •Patients who are cooperative and maintain proper oral hygiene.
- •Intact interproximal and palatal bone extending at least 6 mm apically, with sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque).
排除标准
- •Heavy smokers. 20
- •Patients who exhibit parafunctional occlusal habits 21
- •Pregnant ladies or lactating mothers.
结局指标
主要结局
Volumetric analysis
时间窗: Baseline and 6 months
3D viewer soft tissue; mm changes in the buccal soft tissue contour in comparison to the original ones, at 2,4 and 6 mm from the pre-operative gingival margin
次要结局
- Pink Esthetic Score(6 months after final crown placement)
- Radiographic CBCT measurements(Baseline and 6 months)
- Full-mouth plaque score(Baseline and 6 months)
- Full-mouth bleeding score(Baseline and 6 months)
- Visual Analog Scale(1, 3, and 7 days after the surgery.)
