跳至主要内容
临床试验/CTRI/2025/07/091422
CTRI/2025/07/091422尚未招募Phase 3 4

Comparative evaluation of Injectable Platelet Rich Fibrin, Autologous Fibrin Glue and Hyaluronic Acid Gel for papilla reconstruction; A randomised clinical trial

Anjali Devi Patel1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月2日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To evaluate and compare the effectiveness and outcome of injectable platelet rich fibrin versus autologous fibrin glue versus hyaluronic acid gel in the treatment of maxillary and mandibular interdental papillary deficiencies both clinically and photographically.

研究概览

简要总结

This thesis presents a randomized clinical trial evaluating the effectiveness of injectable platelet-rich fibrin (i-PRF), autologous fibrin glue (AFG), and hyaluronic acid gel in reconstructing interdental papilla—the gum tissue between teeth. The study aims to compare these three biomaterials in terms of tissue regeneration, healing time, aesthetic outcomes, and patient comfort. Subjects with papilla loss received one of the treatments, and their progress was tracked over time. Results suggest that while all three approaches contributed to papilla reconstruction, i-PRF and AFG offered faster healing, and HA gel provided a minimally invasive option with promising cosmetic results.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients aged between 18 to 55 years 2.Presence of interdental papillary loss in the maxillary anterior region 3.Good general health with no systemic conditions affecting periodontal healing 4.Willingness to participate and provide written informed consent 5.Presence of plaque index and gingival index scores within acceptable range.

排除标准

  • Open contacts between the affected teeth.
  • Missing anterior teeth.
  • Pregnant or breastfeeding females
  • Patients with systemic diseases.
  • Patients with poor oral hygiene
  • Patients who take any medications known to cause gingival enlargement, gingival fillers previously done, teeth with caries, proximal restorations, fixed or orthodontic appliances.
  • Patients who had a periodontal surgeries six months prior to selection.
  • Severe periodontal bone loss.

结局指标

主要结局

To evaluate and compare the effectiveness and outcome of injectable platelet rich fibrin versus autologous fibrin glue versus hyaluronic acid gel in the treatment of maxillary and mandibular interdental papillary deficiencies both clinically and photographically.

时间窗: To evaluate and compare the effectiveness and outcome of injectable platelet rich fibrin versus autologous fibrin glue versus hyaluronic acid gel in the treatment of maxillary and mandibular interdental papillary deficiencies both clinically and photographically at the base line ,1 week, 1 month,3 month, 6.month

次要结局

  • • To evaluate the effectiveness and clinical outcome of the injectable -platelet rich fibrin injection in treatment of maxillary and mandibular interdental papillary deficiency.(• To evaluate the effectiveness and clinical outcome of the autologous fibrin glue injection in treatment of maxillary and mandibular interdental papillary deficiency.)

研究者

发起方
Anjali Devi Patel
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Anjali Devi Patel

Faculty of Dental Sciences,IMS,BHU,Varanasi

研究点 (1)

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