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临床试验/NCT07736833
NCT07736833已完成不适用

Efficacy of Liquid Phase Concentrated Growth Factors as an Adjunct to EDTA in the Treatment of Recession Type 1 Defect With Free Gingival Graft

Tanta University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年2月21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
1
主要终点
Width of attached gingiva (AG)

研究概览

简要总结

The present study was designed to investigate the clinical efficacy of liquid-phase concentrated growth factors (LPCGF) as an adjunct to ethylenediaminetetraacetic acid (EDTA) for root surface biomodification prior to free gingival grafting for the management of Cairo type 1 gingival recession defects.

详细描述

Gingival recession is defined by the American Academy of Periodontology, as the exposure of the root surface caused by an apical displacement of the gingival margin relative to the cementoenamel junction. While it seldom leads to tooth loss, gingival recession can contribute to several clinical issues, including root caries, cervical abrasion, dentinal hypersensitivity, and aesthetic concerns .

The etiology of gingival recession is not yet fully understood. Nevertheless, a variety of predisposing factors have been identified, including mechanical trauma, plaque accumulation, periodontal phenotype, tooth malposition, high frenum attachment, and orthodontic treatment. Clinical evidence suggests that gingival recession commonly develops in the presence of multiple interacting risk factors rather than as a result of a single causative factor.

Several classification systems for gingival recessions have been proposed in the literature, with the aim of creating specific categories related to diagnosis, prognosis, and treatment plan. The main classifications were the following: Sullivan & Atkins (1968) ; Mlinek et al (1973) ; Miller (1985) ; Smith (1997) , Mahajan (2010) ; Cairo (2011) ; Kumar (2013) , Cortellini and Bissada (2018) 3and Chambrone and Avila-Ortiz (2021) .

Even though Miller's classification is still very popular, inherent drawbacks associated with the Miller's system have started to emerge, suggesting either a modification or replacement of the Miller's classification system with some of the more recent and updated classification systems.

Cairo et al., introduced a classification system of gingival recession using the level of interdental clinical attachment as an identification criterion. This system identified three recession types namely: recession type 1 (RT1) included defects without loss of interproximal attachment while recession type 2 (RT2) showed interproximal attachment loss .In recession type 3 (RT3), the interproximal attachment loss was more than the buccal site and may be associated with an interproximal intrabony defect .

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

入选标准

  • Adults aged 18 to 50 years old.
  • Patients with good systemic health with no contraindication for periodontal surgery.
  • No history of systemic or local medications within the previous six months that could affect periodontal tissue health or wound healing.
  • Recession depth ≥ 3 mm, measured from the cementoenamel junction (CEJ) to the gingival margin and/ or width of attached gingiva < 3 mm.
  • Presence of identifiable cementoenamel junction (CEJ).
  • Absence of interproximal attachment loss (i.e., intact interdental bone and soft tissue, confirmed radiographically).
  • Ability to maintain adequate oral hygiene, as demonstrated during recall visits.

排除标准

  • Restoration or caries in the site to be treated or non-vital tooth.
  • Previous mucogingival surgery at the defect.
  • Active infectious diseases (hepatitis, HIV, etc.).
  • Smokers and pregnant patients.
  • Teeth that are tilted rotated or have any non-alterable occlusal abnormalities.
  • Sites with tooth mobility.

结局指标

主要结局

Width of attached gingiva (AG)

时间窗: Baseline, 1 month, 3 months, and 6 months

calculated by subtracting probing pocket depth from the width of keratinized gingiva measured from the free gingival margin to the mucogingival junction, as determined by the roll technique

Gingival thickness (GT)

时间窗: baseline, 1 month, 3 months, and 6 months

次要结局

  • Clinical attachment level (CAL)(base line and 6 months postoperative)
  • Probing pocket depth (PPD)(baseline and 6 months postoperative)
  • Recession width (RW)(Baseline, 1 month, 3 months, and 6 months.)
  • Recession depth (RD)(baseline, 1 month, 3 months, and 6 months)
  • Percentage of root coverage (RC)(6 months postoperative)

研究者

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

Moataz Waheid Mohamed Elsaied

Teaching assistant

Tanta University

研究点 (1)

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