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临床试验/NCT07080294
NCT07080294已完成不适用

Use of Injectable Extended Platelet-Rich Fibrin as a Local Adjunctive Therapy in the Treatment of Stage II Periodontitis Patients (Randomized Controlled Clinical Trial)

Mansoura University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年4月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
clinical attachment gain

研究概览

简要总结

The objective of the present study is to assess the clinical effectiveness of local delivery of injectable extended platelet-rich fibrin in subgingival application when used in conjunction with scaling and root planing (SRP) in the treatment of stage II periodontitis.

The primary outcome includes the clinical attachment gain after 6 months, whereas the secondary outcomes include the changes of probing pocket depth, bleeding on probing percentage, plaque and gingival indices and the concentration of matrix metalloproteinase-8 (MMP-8) in gingival crevicular fluid (GCF) after 3 and 6 months.

详细描述

Periodontitis is a chronic inflammatory dysbiotic disease resulting in damage of the periodontal tissue surrounding the teeth. At first, the teeth loosen, and eventually, there may be tooth loss. Periodontitis occurs due to an imbalance in the oral microbiota's natural balance and host resistance (i.e., dysbiosis). In adults, dysbiosis may be the cause of periodontitis, which can lead to inflammatory changes that affect the bone and connective tissue (1, 2).

The goals of today's treatment of periodontitis are to reduce infection, resolve inflammation and create a clinical condition, which is compatible with periodontal health (3). Periodontitis is typically treated initially in a non-surgical way. Non-surgical periodontal therapy consists of scaling and root planing (SRP) combined with oral hygiene instructions. Typically, this results in clinical attachment gain due to resolution of the inflammation. However, findings revealed that in some affected areas, the standard treatment proved to be insufficient and some residual pockets remain after therapy (4).

To reduce the indication of surgical invasive and technically demanding procedures, several adjuncts to SRP have been proposed such as the use of antibiotics or anti-inflammatory drugs. These adjunctive therapies improved treatment outcomes in terms of pocket depth reduction and CAL gain (5). However, their systemic administration requires the use of high dose of active drugs to reach efficient concentration at the treated site, the compliance of the patient to follow the selected administration regimen and could be associated with serious side effects. Consequently, several local treatments such as gels, fibers or chips loaded with different active molecules or drugs have been developed and evaluated in clinical settings (6).

The main advantages of such treatments are the delivery of active drugs at the precise site of the lesions, the reduced risk of side effects and the possibility of 3D stabilization of the blood clot (7). Local application of medications after scaling and root planing (SRP) has shown better results than SRP alone principally in reduction of pocket depth (8). Nonetheless, some materials which are applied locally were found to induce allergic -like reactions, lack the rheological characteristics and sustained release of the active ingredient under investigation (9).

To-date, platelet concentrates have been proven to promote and stimulate wound healing processes and to accelerate angiogenesis due to their concentrated growth factors content and anti-inflammatory molecules. Del Fabbro and his colleagues confirmed the use of growth factors for providing an additional stimulation to physiological healing processes (10).

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with stage II Periodontitis (pocket depth ≤ 5mm and CAL = 3-4 mm).
  • •Age range (30-50) years.
  • •Good compliance with the plaque control instructions following initial therapy.
  • •Availability for follow- up and maintenance program.

排除标准

  • •Periodontitis patients with stage I, III and IV.
  • •Systemic diseases which could influence the outcome of the therapy.
  • •Pregnant and lactating females.

研究组 & 干预措施

extended platelet rich fibrin injection in pocket

Experimental

Thorough periodontal mechanical debridement and injection of ePRF inside the assigned pockets will be performed for 15 patients of stage II periodontitis.

干预措施: extended platelet rich fibrin injection in pocket (Other)

albumin injection in pocket

Experimental

Scaling and root planing and injection of albumin gel alone inside the pockets will be performed for 15 patients of stage II periodontitis

干预措施: albumin injection in pocket (Other)

scaling and root planing

Experimental

Mechanical debridement alone will be performed for 15 patients with stage II periodontitis without injection of any material into the pockets.

干预措施: scaling and root planing (Other)

结局指标

主要结局

clinical attachment gain

时间窗: 6 months

Clinical Attachment Level (CAL) measured from the cementoenamel junction to the base of the gingival sulcus (RD+PD).

次要结局

  • Probing Depth (PD)(6 months)
  • Plaque index (PI).(6 months)
  • Gingival index(6 months)
  • Bleeding on probing (BOP)(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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