Impact of Microneedling on the Gingival Tissue Surrounding Implant Supported Fixed Restoration.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Gingival thickness (GT)
研究概览
简要总结
This randomized clinical trial aims to evaluate the effect of microneedling with and without accelerated growth factor (AGF) injection on gingival tissue surrounding implant-supported fixed restorations. The peri-implant soft tissue phenotype is an important determinant of long-term implant stability and esthetic success. Patients with thin gingival biotype are more susceptible to mucosal recession, soft tissue transparency, and peri-implant complications. Enhancing gingival thickness and keratinized tissue width using minimally invasive methods can improve esthetic and biological outcomes.
Microneedling has recently been proposed as a simple and minimally invasive approach that stimulates local healing by inducing controlled micro-injury. It triggers angiogenesis and the release of intrinsic growth factors that promote soft tissue regeneration. Accelerated Growth Factor (AGF) is an autologous platelet concentrate obtained through a single-step centrifugation technique. It contains a high concentration of platelet-derived and vascular growth factors that enhance tissue repair and collagen synthesis. Combining microneedling with AGF may therefore produce synergistic effects, improving the soft tissue phenotype and peri-implant mucosal stability.
The study will include 20 participants aged 18-34 years with thin gingival biotype (0.8-1 mm) around maxillary anterior implants. Participants will be randomly assigned to one of two groups:
- AGF group: AGF injection alone.
- Microneedling + AGF group: Microneedling using sterile disposable lancets until pinpoint bleeding occurs, followed by AGF injection (0.2-0.3 mL per site).
Clinical parameters including gingival thickness (GT), keratinized tissue width (KTW), probing depth (PD), and bleeding index (BI) will be recorded at baseline, 3 months, and 6 months. All participants will receive standardized zirconia restorations following osseointegration. Statistical analysis will include intra- and inter-group comparisons, with significance set at p < 0.05.
The study is expected to clarify whether combining microneedling with AGF enhances peri-implant soft tissue thickness more effectively than AGF alone. If successful, this combined minimally invasive approach may offer a practical and biologically based technique to improve soft tissue health and esthetics around dental implants.
详细描述
The peri-implant mucosa plays a crucial role in the biological and esthetic stability of dental implants. A thin gingival biotype is often associated with soft tissue recession, marginal bone loss, and esthetic compromise. Conventional augmentation techniques such as connective tissue grafting are effective but involve additional morbidity, donor site discomfort, and variable esthetic results. This study investigates a minimally invasive approach combining microneedling and accelerated growth factor (AGF) injection to enhance the gingival tissue phenotype around implant-supported restorations.
Microneedling is based on creating controlled micro-perforations in the soft tissue surface using fine needles. These micro-injuries induce a natural wound healing cascade that includes platelet activation, release of endogenous growth factors, angiogenesis, and fibroblast stimulation. The process enhances collagen deposition and epithelial thickening, which may increase the overall gingival thickness and keratinized tissue width.
AGF is an autologous blood-derived product obtained by a standardized single-step centrifugation technique that separates platelet-rich fractions containing high levels of biologically active molecules such as PDGF, VEGF, and TGF-β. These factors promote tissue regeneration and accelerate wound healing. Injecting AGF into peri-implant mucosa provides a reservoir of growth factors that stimulate fibroblast activity, improve tissue vascularity, and enhance collagen formation.
The hypothesis of this trial is that combining microneedling with AGF will yield superior soft tissue enhancement compared to AGF alone.
Study Design
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-34 years
- •Thin gingival biotype ( 0.8- 1mm GT at maxillary anterior teeth)
- •Non-smokers
- •Plaque index (PI) score 0-1
- •No bleeding on probing
- •No malocclusion or crowding affecting implant site
排除标准
- •Active orthodontic treatment
- •Previous periodontal surgery at study sites
- •Systemic diseases affecting healing
- •Use of anticoagulants or drugs causing gingival enlargement
- •Mucogingival stress or bruxism
结局指标
主要结局
Gingival thickness (GT)
时间窗: Baseline, 3 months, and 6 months after intervention
Gingival thickness will be measured to assess the effect of accelerated growth factor injection with and without microneedling on peri-implant soft tissue phenotype. Measurements will be taken at the mid-facial point of the implant site using a transgingival file technique combined with digital evaluation via intraoral scanning to ensure accuracy and reproducibility.
次要结局
未报告次要终点
研究者
Mona Al-Ahmady El-Meligy
Lecturer of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology Faculty of Dentistry, Tanta University, Egypt
Tanta University