Hyaluronic Acid Versus I-PRF Combined With Microneedling for Peri Implant Soft Tissue Enhancement: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- Peri-implant gingival thickness
研究概览
简要总结
This study aims to compare the use of microneedling alone versus with hyaluronic acid or i-PRF in conjunction with microneedling in peri-implant mucosa in the esthetic zone to test the superior increase in gingival thickness.
详细描述
Despite the rising demand for esthetics and the prevailing use of dental implants in the recent era, the soft tissue remains a dilemma that affects patients' satisfaction and the implants' longevity in the oral environment, especially in the esthetic region of the maxilla. Various studies have been done to test the effectiveness of microneedling, hyaluronic acid, and i-PRF as alternative non-invasive or minimally invasive methods targeting tissue enhancement in the gingiva, and have proven that they have notable and desirable results. However, there is a lack in the literature regarding the use of these previously mentioned treatment options with regard to peri-implant soft tissue, and which of the delivered solutions offers superior results with reference to peri-implant mucosa in conjunction with microneedling.
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)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with delayed implants placed in the maxillary esthetic region in correct positioning and angulation
- •Patients with peri-implant gingival thickness ≤ 1 mm
- •Patients with healthy gingiva and who can maintain good oral hygiene around implants
排除标准
- •Marginal bone loss ≤ 2 mm
- •Patients with peri-implantitis or periodontitis
- •Patients with systemic conditions or diseases impairing healing or soft tissue metabolism
- •Pregnant or lactating females
- •Patients taking medications affecting the gingiva
研究组 & 干预措施
Microneedling
microneedling into the peri-implant soft tissue site
Microneedling with Hyaluronic Acid (HA)
Microneedling into the peri-implant soft tissue site in addition to the use of HA, repeated 3 times with 7 days gap in between.
干预措施: Hyaluronic Acid (HA) (Drug)
Microneedling with injectable platelet rich fibrin (I-PRF)
Microneedling into the peri-implant soft tissue site, in addition to the use of I-PRF, repeated 3 times with 7 days gap in between.
干预措施: Platelet rich fibrin (Biological)
结局指标
主要结局
Peri-implant gingival thickness
时间窗: 6 months
次要结局
未报告次要终点
研究者
Rahaf Medhat Zayn
Principal investigator
Ain Shams University