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临床试验/NCT07139392
NCT07139392尚未招募3 期

A Clinical Comparison of Connective Tissue Graft and Alb-PRF for Rebuilding Interdental Papilla

shaimaa hamdy0 个研究点目标入组 30 人开始时间: 2025年9月1日最近更新:
干预措施
相关药物

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
主要终点
Papilla Height Gain

研究概览

简要总结

The interdental papilla, a small wedge of gingival tissue positioned between adjacent teeth, plays a crucial role in both dental esthetics and oral function. Loss or deficiency of the papilla results in the formation of "black triangles," which not only compromise a patient's smile but also lead to challenges such as food impaction, phonetic difficulties, and increased risk of periodontal disease. The reconstruction of the interdental papilla is recognized as one of the most challenging procedures in periodontal therapy, particularly when aiming for enhanced esthetic outcomes and patient satisfaction

详细描述

Connective tissue grafts (CTG) have traditionally been regarded as the gold standard for papilla reconstruction due to their predictable augmentation of soft tissues and stable long-term results. However, CTG procedures are invasive, requiring tissue harvesting from a donor site (often the palate), and are associated with increased surgical morbidity and discomfort for patients.

Advances in regenerative medicine have introduced minimally invasive alternatives, such as injectable biologically active platelet-rich fibrin (Bio-PRF). Bio-PRF is an autologous platelet concentrate containing a high concentration of growth factors, fibrin matrix, and immunomodulatory cells. The injectable form is designed to be applied directly into tissue-deficient papillary sites, promoting enhanced angiogenesis, cell proliferation, and tissue regeneration with minimal trauma and improved patient comfort.

Recent clinical interest has focused on comparing these two approaches, CTG and injectable Bio-PRF, in their efficacy for papilla regeneration. While both techniques have demonstrated potential benefits, direct comparative studies are limited. Understanding the relative effectiveness, esthetic outcomes, surgical morbidity, and patient-centered results of these interventions is essential for evidence-based clinical decision making.

This clinical comparison seeks to evaluate and contrast the outcomes of connective tissue grafting and injectable Bio-PRF in the reconstruction of lost or compromised interdental papillae. The study aims to provide valuable insights into the optimal management of papillary defects, guiding periodontal practitioners toward treatments that maximize esthetic and functional results while minimizing patient morbidity.

We hypothesized that no significant difference between the treatment of interdental papilla with connective tissue graft or Bio-PRF.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-55 years
  • Nordland and Tarnow Class I/II papillary loss
  • Good oral hygiene (FMPS & FMBS <20%)
  • Systemically healthy

排除标准

  • Periodontal pockets >4 mm in the target site
  • History of systemic diseases or medications affecting healing
  • Pregnant or lactating women

研究组 & 干预措施

connective tissue graft

Placebo Comparator

Semi-lunar flap elevation, then connective tissue graft sutured under the flap for papilla reconstruction

干预措施: connective tissue graft (Biological)

albumin-PRF

Active Comparator

Albumin- PRF for papilla reconstruction

干预措施: Albumin (5% serum-protein solution containing immunoglobulins) (Biological)

结局指标

主要结局

Papilla Height Gain

时间窗: 6 months follow up

Papilla Height Gain (measured from contact point to papilla tip)

次要结局

未报告次要终点

研究者

发起方
shaimaa hamdy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

shaimaa hamdy

lecturer of oral medicine, oral diagnosis and periodontology

Minia University

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