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临床试验/NCT06625528
NCT06625528进行中(未招募)早期 1 期

The Efficacy of Lyophilized Platelet-Rich Fibrin in Treatment of Periodontal Intra-Bony Defects (A Comparative Clinical, Radiographic and Biochemical Study)

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年11月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
进行中(未招募)
入组人数
36
试验地点
1
主要终点
radiographic parameters

研究概览

简要总结

The present study will be performed to evaluate the efficacy of lyophilized platelet-rich fibrin alone and combined with nanocrystalline hydroxyapatite in treatment of periodontal intra-bony defects through:

  1. Primary outcomes:
  • The clinical parameters including: Probing pocket depth (PPD) reduction and clinical attachment level (CAL) gain.
  • The radiographic parameters including: Marginal bone level (MBL), bone-defect fill.
  1. Secondary outcome: The level of BMP-2 in Gingival crevicular fluid (GCF).

详细描述

Periodontitis is a multi-factorial inflammatory process affecting the periodontal tissues. Among the characteristic signs of periodontal disease is loss of alveolar bone support. The risk of further alveolar bone loss and the probability of tooth loss increases with the presence of intra-bony defects.

Periodontal intra-bony defects (IBDs) are osseous defects with specific morphology, the bottom of these defects is located more apically than the alveolar crest and they are surrounded by bony walls on 1-, 2-, or 3- sides, with the tooth root forming the additional wall. The prevalence of these defects is significantly lower than supra-crestal periodontal defects.

Among the main goals of periodontal therapy is to regenerate the lost periodontal tissues after arresting the progress of the disease. Surgical management of periodontally affected sites includes conventional and regenerative procedures. The conventional modality of surgical debridement allows for reliable access to root surfaces leading only to healing by repair. While the regenerative treatment options allow for the regeneration of destroyed periodontal ligament and bone. Guided tissue regeneration (GTR), placement of bone grafting materials, the addition of biologic mediators and a combination of such techniques are the different forms of periodontal regenerative techniques.

Bone grafts (BGs) and substitutes are classified into autogenic, allogenic, xenogenic and synthetic bone grafts. Synthetic nanocrystalline hydroxyapatite (NCHA) has been extensively applied as bone graft replacement material and characterized by its osteoconductive properties and improved osseointegrative features. The size of the particle was found to be around 18 nm, allowing for quicker vital bone substitution. It has been proved that NCHA can enhance the adhesion of the bone formative cells (osteoblasts) more than micromaterials. Furthermore, the nano-sized particles provide special properties to NCHA such as ahydrated surface layer, a large surface/volume ratio, this layer is actively involved in the homeostasis process, ionic exchange and other techniques involved in the osteogenesis regulation. NCHA is osteoconductive but has inferior osteoinductive properties; therefore, one of the efforts to increase the ability of this material is to combine it with other bioactive materials such as platelet-rich fibrin (PRF).

Platelet-rich fibrin is a second-generation platelet concentrate that has been widely used in the treatment of bone deficiency and its main action is derived from its high content of platelets that release many growth factors (GFs) and cytokines. However, freshly prepared PRF must be used immediately in order to retain the bioactivity of growth factors. In addition, the bio-degradation rate of PRF is fast and irregular, along with the rapid release of growth factors, and then enzymatically hydrolyzed.

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
Single (Outcomes Assessor)

盲法说明

The statistician and the evaluator were blinded, but the operator was not because of the nature of the study

入排标准

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

入选标准

  • All periodontitis patients to be included in this study should be diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm.
  • 2- or 3-wall intra-bony interproximal defect with depth ≥3 mm, a width of ≥3 mm at its most coronal part and 45-55-degree angulation will be selected in order to reduce defect variability.
  • All patients will be free from any systemic diseases according to the American Dental Academy general guidelines for referring dental patients to specialists and other care settings

排除标准

  • Any patients with any systemic condition that contraindicate any surgical intervention.
  • Pregnant or lactating females, smokers, or alcoholic patients.
  • Patients with intra-bony defects received drugs that affect bone turnover such as (chemotherapy and radiotherapy).
  • History of periodontal therapy and antibiotic administration in the last 6 months.
  • Patients taking any medicine which may affect the function of platelet (i.e., aspirin) in the previous 3 months.
  • Miller grade II or greater mobility, furcation involvement as well as one-wall defects and interdental craters.
  • Patients with unacceptable oral hygiene after the re-evaluation of phase I therapy.

研究组 & 干预措施

open flap debridement

Placebo Comparator

Immediately before surgery, patients rinsed with 0.12% chlorhexidine digluconate and povidone iodine solution was used to perform extra-oral antisepsis. The surgical site was anaesthetized. A mucoperiosteal flap was elevated and reflected followed by thorough debridement of all inflammatory granulation tissue from IBD until a sound, healthy bone surface was obtained. Root surface debridement was also performed. Copious irrigation with normal saline solution. The flap was repositioned and sutured.

干预措施: open flap debridement (Biological)

lyophilized platelet rich fibrin

Active Comparator

Immediately before surgery, patients rinsed with 0.12% chlorhexidine digluconate and povidone iodine solution was used to perform extra-oral antisepsis. The surgical site was anaesthetized. A mucoperiosteal flap was elevated and reflected followed by thorough debridement of all inflammatory granulation tissue from IBD until a sound, healthy bone surface was obtained. Root surface debridement was also performed. Copious irrigation with normal saline solution. The lyophilized-PRF granules was hydrated with a few drops of normal saline then, it was applied and packed to fill defect. The flap was repositioned and sutured.

干预措施: open flap debridement (Biological)

lyo-PRF and nanocrystalline hydroxyapatite bone graft

Active Comparator

Immediately before surgery, patients rinsed with 0.12% chlorhexidine digluconate and povidone iodine solution was used to perform extra-oral antisepsis. The surgical site was anaesthetized. A mucoperiosteal flap was elevated and reflected followed by thorough debridement of all inflammatory granulation tissue from IBD until a sound, healthy bone surface was obtained. Root surface debridement was also performed. Copious irrigation with normal saline solution. A mixture of Ly-PRF and n-HA (1:1by weight) was hydrated with a few drops of normal saline then, it was applied and packed to fill the defect. The flap was repositioned and sutured.

干预措施: open flap debridement (Biological)

结局指标

主要结局

radiographic parameters

时间窗: baseline, 3, 6, and 9 months after treatment

The radiographic parameters including: Bone-defect fill in mm.

clinical parameters

时间窗: baseline, 3, 6, and 9 months after treatment.

The clinical parameters including: Clinical attachment level (CAL) gain in mm.

次要结局

  • biochemical evaluation(baseline, 1, 4 and 12 weeks after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa El-Dein Mohamed Maamoun Salatein

assistant lecturer

Al-Azhar University

研究点 (1)

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