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临床试验/NCT06041854
NCT06041854已完成不适用

Comparison Between Allograft and Enamel Matrix Derivative and Allograft in Treatment of Intrabony Defects

Mansoura University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年11月22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
20
试验地点
2
主要终点
Radiographic bone defect fill

研究概览

简要总结

Periodontal intrabony defects represent a major challenge for the clinician in periodontal therapy. If left untreated, these defects represent a risk factor for disease progression and additional attachment and bone loss.

All patients will receive full mouth scaling and root planing and be re-evaluated to assess patient cooperation and maintaining good oral hygiene. Subjects who showed persistent PPD ≥ 5 mm with radiographic evidence of periodontal intrabony defect presence will be included and will be randomly allocated to one of two treatment groups.One group will be treated by surgical treatment and the defects filled by freeze-dried bone allograft mixed with enamel matrix derivative. second group will be treated by surgical treatment and the defects filled by freeze-dried bone allograft .Clinical periodontal parameters (PI, GBI, PPD, CAL) will be re-evaluated at 3, 6 and 9 months after surgery. CBCT will be taken after 9 months of surgery and the defect measurements will be recorded

详细描述

primary goal of periodontal therapy is not arrest the tissue destruction caused periodontal disease only, but also to reconstruct the tissue lost caused by infectious process. Periodontal intrabony defects represent a major challenge for the clinician in periodontal therapy. If left untreated, these defects represent a risk factor for disease progression and additional attachment and bone loss. Surgical intervention is considered the treatment of choice for deep intrabony defects, which have not resolved following completion of cause-related periodontal therapy.

In general, periodontal studies showed that healing of periodontal defect after conventional periodontal therapy by collagenous tissue with epithelial cell migration within the gingival connective tissue and along the root surface. Therefore, a various of methods and techniques used to prevent epithelial ingrowth to the defect site and permit only a selective periodontal cells proliferation in attempt to regenerate periodontal tissues. Regenerative procedures including the use of certain types of bone replacement materials, barrier membranes, enamel matrix derivative (EMD), or various combinations thereof have been shown to facilitate periodontal regeneration characterized histologically by formation of root cementum, periodontal ligament, and alveolar bone and result superior in clinical, and radiographical patient reported outcomes compared to access flap surgery alone.

Various bone graft and bone substitutes materials can be helpful in the tissue restoration. This bone graft include autogenous bone graft, allografts, xenografts, and alloplastic materials. Autologous bone is considered the gold standard because of its biological activity due to vital cells and growth factors. Yet, the autologous bone from intra-oral donor sites is of restricted quantities and availability, and the bone tissue obtained from the iliac crest is described to show faster resorption. Moreover, the harvesting of autologous bone often requires a second surgical site associated with an additional bone defect, potential donor site morbidity limiting their application.

In recent years, the use of allogeneic human bone has been favored worldwide, and several histological and morphological studies have demonstrated that, there is no difference in the final stage of incorporation and new bone formation between allografts and autografts. Thus, the application of processed allogenic bone tissue is a reliable and predictable alternative.

Allogeneic bone graft refers to bony tissue that is harvested from one individual and transplanted to a genetically different individual of the same species, principally osteoconductive, although it may have some osteoinductive capability, depending on how it is processed.

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

入选标准

  • Age range between 30-50 years.
  • Patients with stage III periodontitis, will be diagnosed on the basis of probing pocket depth and clinical attachment loss.
  • Presence of at least one or more radiographically detectable intrabony defect with clinical periodontal pocket depth (PPD) ≥5 mm, clinical attachment loss ≥5 mm, and radiographic depth of the intrabony defect ≥3 mm.
  • No periodontal therapy within the last 6 months

排除标准

  • Smoker and alcoholic patient.
  • Patient with any signs, symptoms or history of systemic disease that might affect the periodontium and interfere with healing process.
  • Pregnant patients.
  • Patient who has traumatic occlusion.
  • Uncooperative patient

结局指标

主要结局

Radiographic bone defect fill

时间窗: at baseline and 9 months

Cone Beam Computed Tomography (CBCT) will be taken prior to periodontal surgery and after 9 months. The amount of reduction in the IBD measurements (defect resolution)

次要结局

  • Clinical attachment level(CAL will be measured at base line, 3, 6, 9 months postoperative)
  • Plaque Index(PI will be measured at base line, 3, 6, 9 months postoperative)
  • Probing pocket depth(PD will be measured at base line, 3, 6, 9 months postoperative)
  • Gingival Bleeding Index(GBI will be measured at base line, 3, 6, 9 months postoperative)

研究者

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

Rouida nouri

M.Sc. - Master Degree of Oral Medicine & Clinical Periodontology

Mansoura University

研究点 (2)

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