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临床试验/NCT04261634
NCT04261634已完成不适用

Comparison of Clinical Effects of Concentrated Growth Factor and Platelet-Rich Fibrin in the Treatment of Adjacent Multiple Gingival Recessions: A Split-Mouth Randomized Clinical Trial

Bulent Ecevit University0 个研究点目标入组 18 人开始时间: 2015年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
主要终点
Complete root coverage

研究概览

简要总结

This study hypothesized that CGFs' placement together with CAF may enhance the healing of soft tissues better than use of PRF together with CAF. Therefore, the aim of this study was to determine the clinical effects of CGF in combination with CAF compared to the clinical effect of PRF in combination with CAF in the treatment of adjacent multiple GRs.

详细描述

The gingival margin, which should be in the cemento-enamel junction (CEJ), migrates to the apical with the effect of many facilitating and triggering etiological factors. As a result of gingival recessions (GRs), the root surface (RS) is exposed, root hypersensitivity, root caries and cervical abrasion may occur, plaque control become difficult, resulting in a non-aesthetic appearance. Platelet concentrates (PCs) increase wound healing and repair by mediating the release of growth factors (GFs), such as platelet-derived GF, fibroblast GF, transforming GF-beta and insulin-like GF-I. These GFs were released from the local application of PCs which may enable better tissue regeneration and repair in dental and medical area.

Platelet-Rich Fibrin (PRF) has a more elastic and more sturdy membrane structure, which is rich in platelets and leucocytes.Concentrated growth factor (CGF) is an another generation of PCs. It is produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix as same as PRF. This study hypothesized that CGFs' placement together with (coronally advanced flap) CAF may enhance the healing of soft tissues better than use of PRF together with CAF. Therefore, the aim of this study was to determine the clinical effects of CGF in combination with CAF compared to the clinical effect of PRF in combination with CAF in the treatment of adjacent multiple GRs.

The patients of this randomized, split-mouth and controlled clinical trial study protocol were selected from individuals referred to the Department of Periodontology, at the Faculty of Dentistry, Bulent Ecevit University, for either dentin hypersensitivity or aesthetic complaints between May 2015 and June 2016.

The subjects were enrolled to this study based on the following inclusion criteria: (1) age > 18 years, (2) systemically and periodontally healthy, (3) non-smokers, (4) presence of ≥2 buccal adjacent Miller Class I or II GR with ≥2 mm GR depth (RD), probing depth (PD) <3 mm and gingival thickness (GT) ≥1 mm on both sides of the maxillary arch, (5) width of keratinized gingiva (KGW) ≥2 mm, (6) presence of identifiable cemento-enamel junction CEJ, (7) central, lateral canine and premolar teeth with GRs in the maxilla (8) full-mouth plaque control record (PCR) ≤20% (O'Leary et al. 1972) and gingival index (GI) scores = 0 (Loe, 1967) and presence of tooth vitality and absence of caries, restorations and furcation involvement in the treated area.

All the subjects received oral hygiene instructions and full-mouth scaling were performed 1 month before surgery. They were instructed to perform a non-traumatic brushing technique (Roll) using an ultra-soft toothbrush. In eighteen patients (mean age 39.67₊10.25 age; 8 females, 10 males), one side of the jaw received PRF+ CAF (37 defects), the opposite site received CGF + CAF (39 defects).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • systemically and periodontally healthy,
  • non-smokers
  • presence of ≥ 2 buccal adjacent Miller Class I and II gingival recession with ≥ 2 mm gingival recession depth , probing depth <3 mm and gingival thickness (GT) ≥ 1 mm on both sides of the maxillary arch
  • width of keratinized gingiva ≥ 2mm
  • presence of identifiable cemento-enamel junction
  • full-mouth plaque index (PI) < 20 % and gingival index (GI) scores <1,
  • presence of tooth vitality and absence of caries, restorations and furcation involvement in the treated area,

排除标准

  • patients who had systemic problems that wound contraindicate for periodontal surgery, - usage of medications known to interfere with healing and to cause gingival enlargement - recession defects associated with demineralization, deep abrasion,
  • previous surgery in the defects area within the past 1 year,
  • pregnant or lactating females
  • drug and alcohol abuse

结局指标

主要结局

Complete root coverage

时间窗: 6 months

Change from baseline in percentage of complete root coverage at 6th months.

次要结局

  • Recession depth(6 th months)
  • Probing depth(6 th months)
  • Percentage root coverage(6 months)
  • Keratinized gingiva width(6 months)

研究者

发起方
Bulent Ecevit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Seyma Bozkurt Doğan

Associate Professor

Ankara Yildirim Beyazıt University

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