Clinical Efficacy of Injectable Platelet-Rich Fibrin (i-PRF) Versus Hemolaser Therapy for Interdental Papilla Reconstruction in Comparison to Non-Surgical Periodontal Therapy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 4. Papillary deficient area
研究概览
简要总结
This randomized controlled trial aims to evaluate and compare the effectiveness of Injectable Platelet-Rich Fibrin (i-PRF) and Hemolaser Therapy in the reconstruction of the interdental papilla, with a non-surgical control group for baseline comparison. The study will be conducted over 6 months to 1 year at the Department of Periodontology, MCODS, Mangalore.
Study Groups include
- Control Group – Receives oral hygiene instructions, supportive periodontal care, and professional cleaning as needed, without regenerative or laser intervention.
- Test Group 1: i-PRF – Autologous i-PRF will be prepared by centrifuging 10 ml of blood at 700 rpm for 3 minutes. The obtained fibrin will be injected into papillary-deficient sites using a specific angulated technique under anesthesia, followed by gentle massage of the papilla.
- Test Group 2: Hemolaser Therapy – A modified PBMT protocol using a 635 nm diode laser is applied to four points around the papilla. Blood is induced into the papillary space by curettage and then irradiated again. The procedure is repeated on Day 5 and Day 10.
Outcomes Measured
Clinical parameters: papilla fill, tissue volume, and esthetic outcomes
Patient-reported esthetic satisfaction
Stability of regenerated papilla at 1, 3, and 6 months
Analysis: Photographic evaluation using Image J software with standardized imaging techniques and calibration against a periodontal probe will be used for quantitative assessment.
This study explores the regenerative potential and patient-centered outcomes of i-PRF and Hemolaser Therapy for minimally invasive interdental papilla reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age group between 18-60 years.
- •2.Patients with Papilla Presence Index 2 (PPI 2) and Papilla Presence Index 3 (PPI 3) interdental papillary loss score with radiographic evidence of no bone loss (Cardaropoli et al,2004) 3.Patients with a plaque index and gingival index score between zero and one.
- •4.Patients having Periodontal probing depth less than 3mm 5.Vertical distance from the interdental contact point to the crest of the interdental bone less than 5mm measured from intra oral periapical radiograph.
排除标准
- •1.Patients with known systemic disease or blood dyscrasias or on any medication known to interfere with the outcomes of periodontal therapy.
- •2.Smokers, pregnant women, and nursing mothers.
- •3.Patients having open contact.
- •4.Patients having PPI 4 score.
- •(Cardaropoli et al,2004) 5.Previously treated for periodontal reasons before 6 months.
结局指标
主要结局
4. Papillary deficient area
时间窗: 1 month | 3 months | 6 months
1. Papilla presence index
时间窗: 1 month | 3 months | 6 months
2. Papillary width
时间窗: 1 month | 3 months | 6 months
3. Papillary height
时间窗: 1 month | 3 months | 6 months
次要结局
- VAS Esthetic Score(1 month)
研究者
Dr. Madhumitha M
Manipal College of Dental College