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临床试验/NCT06936605
NCT06936605尚未招募不适用

The Use of Integrin Binding Domain Loaded Hydrogel (RGD) With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defect (Randomized Clinical Trial Study)

Minia University0 个研究点目标入组 45 人开始时间: 2025年4月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
45
主要终点
CAL by millimeters

研究概览

简要总结

Periodontal regeneration is a complex process that involves coordinated activities and interactions of many cell types, extracellular matrix, cytokines, and specific growth factors to restore tissue integrity. The most important challenge facing periodontal regeneration is cellular insufficiency. Periodontal defects usually have a limited regenerative capacity due to their bounded surface area which is supposed to provide the wound area with a limited number of viable cells and a limited amount of biologic mediators. Cell recruitment and adhesion into the defect area are essential for cells to survive and secrete collagen.

Apoptosis is initiated when failure in adhesion in many different cell types occurs. Some periodontal treatment options failed in the reconstruction of the defect due to failure in wound stabilization and subsequent cell adhesion. Many treatment options have been developed to enhance defect stability and cellular recruitment including the use of GTM and different biologics. However, the treatment outcomes vary considerably depending on the level of the defect cellularity and the degree of cell recruitment into the defect area. For maximum outcomes, enhanced stability, vascularity, and biologics-sustained delivery were suggested. The minimally invasive surgical technique (MIST) suggested by Cortellini et al. offers a suitable level of tissue preservation that could help in defect stability and cellular adhesion. It was suggested to promote flap stability, maintain space, and maintain a greater amount of blood supply at the alveolar crest and papillary levels.

详细描述

Periodontitis is an inflammatory multifactorial disease initiated by pathogenic bacteria accumulated as a biofilm on the tooth surface leading to clinical attachment loss (CAL), pocket formation (PD), bleeding on probing (BOP), and bone loss which if neglected may lead to increased tooth mobility and final tooth loss. Pathological tooth mobility may arise from extensive alveolar bone loss, traumatic occlusion, acute periodontal inflammation, and apical tooth displacement. Treating tooth mobility can be a challenging process, particularly for patients with severe periodontitis, including those in stage III or IV, who often experience a range of these symptoms. ue to compromised periodontal support. Therefore, effective treatment not only relies on periodontal therapy but also on occlusal stability and tooth splinting

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)

盲法说明

patients do not know the type of treatment and outcomes assessor does not know type of group

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

  • • All patients included will have moderate to advanced periodontitis.
  • Patients included in this study will be free from any systemic diseases according to criteria of Modified Cornell Medical Index(10).
  • Patients who had not undergone any type of regenerative periodontal therapy six months prior to the initial examination.

排除标准

  • • Patients with systemic diseases, smokers, pregnant (female).
  • Patients received antibiotics or non-steroidal anti-inflammatory drugs six months before the beginning of the study.

研究组 & 干预措施

negative control group

Placebo Comparator

Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with minimally invasive non-surgical technique

干预措施: RGD Peptide (Drug)

control group

Placebo Comparator

Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with minimally invasive non-surgical technique with placebo hydrogel

干预措施: RGD Peptide (Drug)

study group

Active Comparator

Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with minimally invasive non-surgical technique with RGD hydrogel

干预措施: RGD Peptide (Drug)

结局指标

主要结局

CAL by millimeters

时间窗: baseline, 3months and 6 months

Measure clinical attachment loss pre and after-intervention

次要结局

未报告次要终点

研究者

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

shaimaa hamdy

lecturer in periodontology

Minia University

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