跳至主要内容
临床试验/NCT05908929
NCT05908929已完成不适用

Comparative Evaluation of Clinical Parameters in Early-Stage III Grade A Periodontitis Patients After Insertion of Platelet Rich Fibrin as Step 2 Phase I Therapy in Periodontal Pockets: A Randomized Clinical Trial

Federico II University4 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2022年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
4
主要终点
pocket depth

研究概览

简要总结

Periodontal regenerative therapy has focused on various non-surgical and surgical treatment methods. Platelet-rich fibrin (PRF) has shown to possess multiple uses, including properties that promote healing of both soft and hard tissues. In the present study, we hypothesized that the addition of PRF into periodontal pockets, as an adjunct to conventional scaling and root planing (SRP), would enhance the outcomes of non-surgical periodontal therapy. This split-mouth randomized controlled clinical trial included 26 periodontal pocket sites in 13 patients with periodontitis. The pockets were randomly assigned as either test or control sites. In the test group, PRF was placed as an adjunct to SRP, while the control group received SRP alone. Probing pocket depths (PPD), clinical attachment levels (CAL), gingival recession (GR), plaque index (PI), and gingivitis index (GI) were measured at baseline and at six weeks. The wound healing index was measured during the six-week follow-up period.

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
None

入排标准

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

入选标准

  • either gender,
  • aged 18 years or older,
  • patients without a medical history of systemic diseases,
  • patient with chronic periodontitis
  • patient with 5 or 6 mm of probing depth

排除标准

  • patients with medical history of systemic disease or bleeding disorders
  • presence of other gingival diseases (such as leukoplakia, lichen planus, pemphigoid disorders, pemphigus vulgaris, herpetic lesions, Necrotizing Ulcerative Periodontitis (NUP)
  • pregnancy
  • history of any drug usage affecting the periodontium for the past six months (such as systemic antibiotic therapy)
  • previous periodontal treatment in the last six months
  • teeth with untreated caries
  • endodontic lesions and grade II or more mobility
  • subjects with acute exacerbation of periodontitis
  • patients with systemic
  • disease or condition that could affect tissue healing (e.g., autoimmune disease)
  • severe furcation involvement (grade II and III)
  • abutment for prosthetic rehabilitation
  • active orthodontic therapy

结局指标

主要结局

pocket depth

时间窗: 6 weeks

Probing pocket depths (PPD), clinical attachment levels (CAL), gingival recession (GR), plaque index (PI), and gingivitis index (GI) were measured

次要结局

未报告次要终点

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Niccoló Giuseppe Armogida

Doctor in Dental Sciences, Principal Investigator

Federico II University

研究点 (4)

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