Comparative Evaluation of Microneedling With Injectable PRF and Hyaluronic Acid for Papilla Reconstruction: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Papillary height
研究概览
简要总结
This randomized split-mouth clinical trial aims to compare the clinical effectiveness of microneedling combined with injectable platelet-rich fibrin (i-PRF) versus hyaluronic acid (HA) gel injection in the reconstruction of Class I interdental papilla loss. The study hypothesizes that MN + i-PRF will yield greater papillary regeneration, offering a minimally invasive, biologically active alternative to traditional surgical approaches for soft-tissue esthetic rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Plaque index <1
- •Gingival index <1
- •Class I papillary loss (Nordland and Tarnow classification)
- •Probing depth ≤4 mm at the test site
- •Inter-proximal bone crest distance ≤7 mm from the contact point.
排除标准
- •Pregnancy
- •Lactation
- •Uncontrolled systemic diseases (e.g., diabetes)
- •Anticoagulant therapy
- •Recent radiotherapy
- •Orthodontic treatment
- •Midline diastema
- •High frenum attachment
- •Class II/III papillary loss.
研究组 & 干预措施
HA
Hyaluronic Acid Filler
干预措施: Hyaluronic Acid (HA) (Other)
iPRF
干预措施: Injectable Platelet Rich Fibrin (Biological)
结局指标
主要结局
Papillary height
时间窗: Baseline, 6 weeks, and 12 weeks.
from the mucogingival junction to the papilla tip
Papillary width
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Amal Jamjoom, BDS, MS.
Assistant Professor
King Abdulaziz University