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临床试验/NCT03588052
NCT03588052Unknown不适用

Evaluation of Esthetic Root Coverage Using Platelet-Rich Fibrin Versus Subepithelial Connective Tissue Graft With Vestibular Incision Subperiosteal Tunnel Access Technique in Patients With Multiple Gingival Recessions: A Randomized Controlled Clinical Trial

Cairo University0 个研究点目标入组 28 人开始时间: 2018年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
28
主要终点
Amount of root coverage

研究概览

简要总结

Patients with gingival recession, complain of excessive tooth length that affects their appearance during smiling or functioning. The main goal of plastic periodontal surgeries is to restore patient's esthetic demands with the regeneration of gingival and periodontal tissues.

Although SCTG is considered a gold standard, it has its own limitations like patient morbidity and graft availability. Consequently, PRF has been introduced in an attempt to overcome the drawbacks of SCTG and achieve optimum results in root coverage.

The minimally invasive VISTA technique allows better access with coronal positioning and stabilization of gingival margin to achieve complete root coverage. In addition to platelets-rich fibrin that gives a predictable and reproducible result in restoring the amount of keratinized tissue, root coverage and better esthetic outcome. The use Vestibular incision subperiosteal tunneling access (VISTA) with platelet-rich fibrin will be used to achieve complete root coverage.

详细描述

Gingival recession is defined as apical displacement of gingival margin beyond the cementoenamel junction leading to the exposure of root surface. There are various etiologic factors for gingival recession like trauma, infection and other anatomical factors.

Nowadays, periodontal plastic surgeries for treatment of gingival recession have become an important array due to increase in patient's esthetic demands and other conditions such as dentin hypersensitivity, root caries or abrasion, keratinized tissue augmentation and gingival margin discrepancy.

Subepithelial connective tissue grafts (SCTG) are considered the gold standard to obtain maximum root coverage due to its characteristics of quick keratinization and periodontal connective tissue adherence, in addition to its good blood supply to the graft and high degree of gingival color match and esthetics. However, the application of this technique is limited by the thickness of the donor tissue, anatomical factors, limited quantity compromising their use in multiple recession, tissue morbidity, and technique sensitive with postoperative pain, bleeding and swelling.

Accordingly, alternative membranes and new biomaterials have been introduced to overcome the limitations of SCTG.

Platelet rich fibrin (PRF) was introduced; a second generation platelet concentrate. PRF contains growth factors that play an essential role in soft and hard tissue regeneration; they promote fibroblastic proliferation, increase tissue vascularization, enhance soft tissue healing potential and accelerate bone regeneration. These growth factors include (PDGFs), epidermal growth factor (EGF), transforming growth factor beta (TGF-β), vascular endothelial growth factor (VEGF).

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
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Multiple adjacent maxillary or mandibular gingival recessions Miller class І or II
  • •Good oral hygiene with full mouth plaque score (FMPS) ≤ 20% (O'Leary et al. 1972)

排除标准

  • •Any systemic condition that may contraindicate periodontal surgery
  • •Individuals taking medications that interfere with periodontal tissue health or healing
  • •Previous periodontal plastic surgery in the selected sites for at least 6 months before the study
  • •Pregnancy or lactating women
  • •Former or current smokers
  • •Active periodontal disease
  • •Non-compliant patients.
  • •Any restorations found in the selected sites

研究组 & 干预措施

VISTA using PRF

Experimental

Vestibular incision subperiosteal tunnel access combined with Platelets-Rich Fibrin

An intravenous blood will be drawn from the patient in a glass-coated plastic tubes, centrifuged at 3000 rpm for 10-12 min. A Platelets rich fibrin membrane will then be obtained

干预措施: VISTA using PRF (Procedure)

VISTA using SCTG

Active Comparator

vestibular incision subperiosteal tunnel access combined with subepithelial connective tissue graft

Subepithelial connective tissue graft will be harvested from the palate, secured in the tunnel to cover the root dehiscence then sutured

干预措施: VISTA using SCTG (Procedure)

结局指标

主要结局

Amount of root coverage

时间窗: 6 months

complete root coverage after surgical correction measured in millimeters by using periodontal probe

次要结局

  • Root Coverage Esthetic score a numbering score(6 months)
  • Keratinized Tissue Width in millimeters(6 months)
  • Post-Operative Pain a numerical rating scale(14 days)
  • Post-Surgical Patient Satisfaction numerical rating scale(14 days)
  • Post-Operative Swelling verbal rating scale(7 days)
  • Probing depth in millimeters(6 months)
  • Clinical Attachment level gain in millimeters(6 months)
  • Gingival Thickness in millimeters(6 months)

研究者

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

Yasmin Medhat Sery

B.Sc. in Oral and Dental Medicine

Cairo University

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