跳至主要内容
临床试验/NCT06591416
NCT06591416已完成不适用

Minimally Invasive Surgical Technique with and Without Granulation Tissue Preservation Using a Combination of Β Tri-Calcium Phosphate and Hyaluronic Acid Gel

Misr University for Science and Technology2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
Clinical attachment level

研究概览

简要总结

In the fast-growing era of contemporary periodontology, the understanding of biological concepts in wound healing together with the evolution of the flap design and biomaterials applied in periodontal regeneration allowed for improved minimally invasive surgical techniques. As minimally invasive approaches reduce the surgical trauma, maintain soft tissue support which allow stable primary closure of the wound. These advantages have led more researchers to apply the concept of minimally invasive surgical techniques (MISTs) in the treatment of infrabony lesions.

Granulation tissue is an immature connective tissue that appears naturally during chronic inflammation or wound healing. This tissue is not a cause of periodontitis.

So, no need to remove it during periodontal treatment. The aim of preservation of the defect-filling granulation tissue after detachment of its base is assumed to act as a soft tissue support, and to increase wound stability especially in the area of the interdental papilla and avoid post-operative marginal recession. One of the alloplastic bone grafts is βeta tri-calcium phosphate (β-TCP). β-TCP has been widely used in periodontal regeneration, where many studies used beta tri-calcium phosphate alone or in combination with other grafting materials in different surgical regenerative procedures have shown promising results for bone filling and new vital bone formation. Hyaluronic acid gel shows anti-inflammatory, antibacterial, and antioxidant properties in the treatment of periodontal diseases. In addition, due to its viscoelastic properties, it can be used as an adjunct to maintain space during periodontal tissue regeneration.

A concentration of 0.8% hyaluronic acid gel has been used effectively in the non-surgical and surgical management of periodontal diseases.

Aim of The Study The aim of the present study is to evaluate the effects of the minimally invasive surgical technique with and without granulation tissue preservation using a combination of beta tri calcium phosphate and hyaluronic acid gel.

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)

入排标准

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

入选标准

  • Patient age ranged from 30 to 50 years old for both genders.
  • Patients are medically free according to the American society of anesthesiologists (ASA) considered as ASA I.
  • The selected participants with a diagnosis stage III grade B periodontitis.
  • Defect morphology: Isolated interproximal infrabony defect of at least 5mm CAL which does not extend beyond the adjacent interproximal region.
  • Optimal compliance as assessed during the case related phase I therapy and evidenced by no missed treatment appointments and positive attitude toward oral hygiene.
  • Bleeding on probing <25%.

排除标准

  • Smoker and pregnant patients.
  • Multiple, interconnected vertical defects.
  • Generalized horizontal bone defects.
  • Teeth with incorrect endodontic treatment or restoration.
  • Stage I, II or IV periodontitis.
  • Patient who need complex prosthetic rehabilitation.

结局指标

主要结局

Clinical attachment level

时间窗: 6 months

measured from cemento-enamel junction to the base of the pocket by using william's graduated periodontal probe

次要结局

未报告次要终点

研究者

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

yomna Medhat Elsaka

Principle investigator

Misr University for Science and Technology

研究点 (2)

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