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临床试验/NCT02380872
NCT02380872已完成不适用

Cytokine (IL-1ß) and Matrix Metalloproteinase (MMP) Levels in Gingival Crevicular Fluid After Use of Platelet Rich Fibrin or Connective Tissue Graft in the Treatment of Localized Gingival Recessions

Ege University2 个研究点 分布在 2 个国家目标入组 24 人开始时间: 2012年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Change from Baseline in MMP-9 gingival crevicular fluid level at 10 days, 1, 3 and 6 months

研究概览

简要总结

The main objective of this study was to evaluate the matrix metalloproteinase (MMP)-8, and -9, tissue inhibitor of matrix metalloproteinase and interleukin-1beta levels in gingival crevicular fluid during the early and late stages of healing for gingival recession sites treated by coronally advanced flap plus platelet rich fibrin (PRF) compared to CAF plus connective tissue graft. As PRF consists of several growth factors, it may enhance the healing potential of soft tissues, the investigators hypothesized that using PRF in the treatment of gingival recessions might regulate inflammation and promote wound healing.

详细描述

The aim of this study was to evaluate the effect of PRF by assessing gingival crevicular fluid (GCF) levels of MMP-8, MMP-9, tissue inhibitor of matrix metalloproteinase (TIMP-1) and interleukin-1beta (IL-1β) during the early and late stages of healing following coronally advanced flap (CAF) plus PRF or CAF plus connective tissue graft (CTG) treatment.

Primary outcome variables were biochemical parameters, such as: GCF MMP-8, -9, TIMP-1 and IL-1β levels. The secondary outcome variables were change in gingival recession expressed as recession reduction in millimeters at follow-up visits.

Sample size has been estimated in 24 subjects per treatment groups. Random allocation of the treatment sites to test (CAF+ PRF) and control (CAF + SCTG) groups will be performed using a computerized selection of random numbers for allocation of the study groups.

Biochemical parameters: GCF samples were obtained from each recession defect in each subject immediately prior to treatment of recessions and at 10 days, 1 month, 3 months and 6 months after surgery.

Periodontal parameters including probing depth (PD), clinical attachment level (CAL), and gingival recession parameters including recession depth (RD), recession width (RW), and keratinized tissue width (KTW),were assessed by a calibrated examiner. At baseline and at 6 months, PD, RD, RW and KTW were evaluated by clinical assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
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

  • Similar bilateral Miller Class I or II localized gingival recessions at least ≥ 2 mm located on incisors, canines or premolars on both jaws
  • Identifiable cementoenamel junction
  • Age ≥ 18 years
  • Presence of tooth vitality and absence of restorations and superficial caries in the area to be treated
  • No periodontal surgical treatment in the previous 24 months on the involved sites
  • Sufficient palatal donor tissue for the indicated SCTG.

排除标准

  • Patients with a pregnancy or lactation period or self-reported history of antibiotic medication within three months
  • Molar, mobile or teeth with crown or filling were also excluded.

研究组 & 干预措施

Connective tissue graft

Active Comparator

Connective tissue graft Soft tissue harvested from palatum of the subjects.

干预措施: Connective tissue graft (Procedure)

结局指标

主要结局

Change from Baseline in MMP-9 gingival crevicular fluid level at 10 days, 1, 3 and 6 months

时间窗: Baseline, 10 days, 1, 3 and 6 months

Change from Baseline in MMP-8 gingival crevicular fluid level at 10 days, 1, 3 and 6 months

时间窗: Baseline, 10 days, 1, 3 and 6 months

Change from Baseline in IL-1beta gingival crevicular fluid level at 10 days, 1, 3 and 6 months

时间窗: Baseline, 10 days, 1, 3 and 6 months

Change from Baseline in TIMP-1 gingival crevicular fluid level at 10 days, 1, 3 and 6 months

时间窗: Baseline, 10 days, 1, 3 and 6 months

次要结局

  • Gingival recession depth(6 months)

研究者

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

Gülnihal Eren, Research Asisstant

Research Assistant

Ege University

研究点 (2)

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