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临床试验/NCT05360511
NCT05360511已完成早期 1 期

Erythropoietin Gel as an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects. A Randomized Controlled Clinical Study

Ain Shams University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年7月1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
已完成
入组人数
26
试验地点
1
主要终点
Evaluation of Plaque index (PI):

研究概览

简要总结

The aim of the study is to evaluate the use of erythropoietin gel as an adjunct to xenograft in the surgical management of intrabony periodontal defects.

详细描述

In the periodontal disease there is an interaction of the biofilm with the immune response of the host which results in an imbalance between bacterial virulence and the host defense causing changes in bone and connective tissue homeostasis .

Armitage's 1999 classified periodontitis to either chronic or aggressive . In 2017, the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP) classified the periodontal disease using a new staging and grading system. Staging is determining the severity of the disease and the complexity of treatment of the disease, while grading gives additional data about the biological consideration of the disease, such as analyzing the history for the rate of progression and predicting the risk for further progression.

Periodontitis is classified to four stages ranging from Stage I: Initial periodontitis the clinical attachment level (CAL=1-2mm), Stage II: Moderate periodontitis (CAL= 3-4 mm), Stage III: Severe periodontitis and increased potential for tooth loss (<4), and (CAL ≥5mm), Stage IV: Severe periodontitis with increased risk for tooth loss (≥5) and (CAL≥5mm). Grading is determined by the risk factors like smoking, diabetes, and outcomes of scaling and root debridement. Grade A: Low rate of progression (no CAL loss over 5 years), Grade B: Moderate rate of progression (CAL loss<2mm over 5years), and Grade C: High rate of progression (CAL loss ≥2 mm over 5 years) .

The periodontal tissue break down happens because of both the direct effect of the microbial invasion and the indirect effect of the host immune response, this happens when the bacterial invasion results in bacterial products that cross the junctional epithelium which stimulates the host immune response resulting in tissue breakdown .

Pattern of bone destruction in periodontitis can be horizontal or vertical .Horizontal bone loss appears as an even bone destruction leading to a uniform decrease in the bone height in relation to the teeth. Vertical bone loss results in formation of a triangular area of missing bone, known as triangulation. Vertical bone loss could result in angular defects and intrabony pocket formation which become very challenging in treatment.

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 (Participant)

入排标准

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

入选标准

  • Both genders within age range of 20-50 years.
  • Patients diagnosed with periodontitis (Stage III).
  • Test site criteria: probing pocket depth ≥6mm and CAL ≥3mm. All these criteria will be determined after phase I conventional periodontal therapy.
  • Patients with three-wall intrabony defect.
  • Systemically free patients as evidenced by Burket's oral health history questionnaire .
  • Ability to attend the treatment sessions and comply with its procedures, the recall visits and oral hygiene protocol.

排除标准

  • Pregnant or lactating females.
  • Patients under any medication that affect periodontal healing.
  • Vulnerable individuals

研究组 & 干预措施

Group A (Test group)

Experimental

Group A (Test group): Twelve patients will be subjected to open flap debridement and application of particulate xenograft + erythropoietin gel.

干预措施: particulate xenograft + erythropoietin gel. (Drug)

Group B (Control group)

Active Comparator

Group B (Control group): Twelve patients will be subjected to open flap debridement and application of particulate xenograft.

干预措施: particulate xenograft (Combination Product)

结局指标

主要结局

Evaluation of Plaque index (PI):

时间窗: 6 months after the surgery.

it will be described by a number on a scale from 0 to 5 as follows: 0 = No plaque.1 = Separate flecks of plaque present at the cervical margin.2 = A thin, continuous band of plaque.3 = A band of plaque wider than 1 mm.4 = Plaque affecting at least 1/3, but not 2/3 of the side of the crown.5 = Plaque affecting 2/3 or more of the side of the crown.

Evaluation of the Sulcus bleeding index (SBI):

时间窗: 6 months after the surgery.

it will be described by a number on a scale from 0 to 5 as follows: 0: No inflammation; no bleeding on probing. 1. = Bleeding on gentle probing; tissue appears normal. 2. = Bleeding on probing and change in color due to inflammation. 3. = Bleeding on probing, change in color and slight edema. 4. = Bleeding on probing, color change, and obvious edema. 5. = Bleeding on probing and spontaneous bleeding, also color change and obvious edema.

Evaluation of the probing depth :

时间窗: 6 months after the surgery.

it will be measured from the gingival margin to the depth of the periodontal pocket using a periodontal probe in millimeters.

Evaluation of the clinical attachment level :

时间窗: 6 months after the surgery.

it will be measured from the cemento-enamel junction to the depth the periodontal pocket by periodontal probe in millimeters.

Evaluation of healing.

时间窗: two weeks after the surgery.

it will be evaluated by the Early Healing Index (EHI) on a scale from 1 to 5 as follows: 1. = complete flap closure - no fibrin line in the interproximal area. 2. = complete flap closure - fine fibrin line in the interproximal area 3= complete flap closure - fibrin clot in the interproximal area. 4 = incomplete flap closure - partial necrosis of the interproximal tissue. 5 = incomplete flap closure - complete necrosis of the interproximaltissue.

次要结局

  • Radiographic assessment .(6 months after the surgery.)

研究者

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

Roaa Mostafa Esmaiil

Principal Investigator

Ain Shams University

研究点 (1)

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