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临床试验/NCT03417232
NCT03417232
已完成
不适用

Biologically Guided Flap Stability: the Role of Periosteum Retention on the Performance of the Coronally Advanced Flap. A Double Blind Randomized Clinical Trial

University of Siena0 个研究点目标入组 40 人2013年4月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Gingival Recession, Localized
发起方
University of Siena
入组人数
40
主要终点
CRC
状态
已完成
最后更新
8年前

概览

简要总结

Aim: to evaluate the possible benefit on wound healing and flap stability of periosteum inclusion, comparing a "split-full-split" thickness flap elevation versus a "split" thickness approach performed during CAF for the treatment of isolated-type gingival recessions in the upper jaw.

Material and Methods: forty patients were randomized, 20 were treated with "split-full-split" (test group) and 20 with a "split" approach (control group). Analyzed parameters at 1 year were: CRC, percentage of Recession Coverage (RC), Keratinized tissue (KT) gain, patient-related outcome measurements.

详细描述

Treatment of buccal gingival recession (GR) is the common clinical requirement from patients who are mainly concerned about aesthetics. Noteworthy are also requests linked to root sensitivity, difficulty in oral hygiene procedures, presence of root caries and non-carious cervical lesions. GR defects, when left untreated, do not improve spontaneously and may progress toward increased recession depth (RD) and clinical attachment loss which increase the patient's aesthetic concern and the clinical discomfort due to augmented dental hypersensitivity. Complete root coverage (CRC) can be considered the primary clinical outcome and selecting the surgical technique depends mainly on the local anatomical characteristics and on the patient's demands. In patients with a residual amount of keratinized tissue apical to the recession defect, the coronal advanced flap (CAF) may be recommended. This surgical technique results in optimal root coverage, good color blending of the treated area with respect to adjacent soft tissues and a complete recovery of the original (pre-surgical) soft tissue marginal morphology. Furthermore, post-operative morbidity is reduced to a single area of surgical intervention and the overall chair time is limited. When utilizing CAF technique, critical factors in CRC have been described in the literature. Flap positioning coronal to the CEJ and a tension-free flap design are among the most important ones. Moreover, flap thickness has been shown to influence the clinical outcomes of CAF procedure . Coronally advanced flap has been widely validated by the literature for the treatment of single recession defects and, currently, different flap designs and technical modifications are available to clinicians. De Sanctis and Zucchelli have recently introduced the "split-full-split" flap elevation modality. According to the authors, the modulation of flap thickness, produced by the inclusion of periosteum in the central area, increases flap thickness in the portion of the flap residing over the previously exposed avascular root surface. This, in turn, would give better stability to the flap. However, the partial-thickness flap approach is still commonly performed in the clinical practice and it is validated in the literature. To date, evidence is still lacking on the influence of including the periosteum in the flap when compared with a split thickness approach in obtaining a CRC. Thus, the aim of this double blind, controlled and randomized clinical trial was to evaluate the possible benefit on wound healing and flap stability of periosteum inclusion comparing a "split-full-split" flap elevation versus a "split" thickness approach when CAF is performed for the treatment of isolated-type gingival recessions in the upper jaw.

注册库
clinicaltrials.gov
开始日期
2013年4月1日
结束日期
2015年4月30日
最后更新
8年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Prof. Marco Ferrari

Full Professor

University of Siena

入排标准

入选标准

  • age \>18 years,
  • no systemic diseases or pregnancy,
  • smoking ≤10 cigarettes/day,
  • full-mouth plaque score and full-mouth bleeding score ≤20%,
  • presence of at least one Miller class I or II isolated recession defect (Miller, 1985) in the upper jaw and at least 2 mm of keratinized tissue apical to the recession,
  • recession depth (RD) equal to or greater than 2mm,
  • identifiable cemento-enamel junction (CEJ),
  • vital teeth, free from caries or prosthetic crown,

排除标准

  • systemic diseases or pregnancy,
  • history of periodontal surgery at experimental sites.

结局指标

主要结局

CRC

时间窗: 12 months

Percentages of recession with a Complete Root Coverage

次要结局

  • RC(12 months)
  • VAS discomfort(12 months)
  • VAS esthetic(12 months)
  • VAS satisfaction(12 months)
  • KTH(12 months)

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