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临床试验/NCT05270941
NCT05270941已完成不适用

Platelet Rich Fibrin Prepared With Titanium Connective Tissue Graft in Treatment of Gingival Recessions

Necmettin Erbakan University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年1月12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
2
主要终点
Complete root coverage [ Time Frame: 6 months

研究概览

简要总结

The aim of this study was to treat the areas with Miller Class I bilateral multiple gingival recession in the maxillary teeth using the Titanium Platelet-Rich Fibrin (T-PRF), an autogenous biomaterial applied in combination with a Modified Coronally Positioned Flap (MCPF) prepared using microsurgical techniques, and the gold standard Subepithelial Connective Tissue Graft (SCTG), to evaluate the efficacy of the treatments and to compare the clinical results 6 months after the treatment.

详细描述

AİM:

The aim of this study was to treat the areas with Miller Class I bilateral multiple gingival recession in the maxillary teeth using the Titanium Platelet-Rich Fibrin (T-PRF), an autogenous biomaterial applied in combination with a Modified Coronally Positioned Flap (MCPF) prepared using microsurgical techniques, and the gold standard Subepithelial Connective Tissue Graft (SCTG), to evaluate the efficacy of the treatments and to compare the clinical results 6 months after the treatment.

MATERIALS AND METHODS A total of 20 patients (118 defects), consisting of 13 females and 7 males, with maxillary bilateral Miller Class I gingival recession who were aged between 18 and 65, applied to Necmettin Erbakan University, Faculty of Dentistry, Department of Periodontology and had aesthetic anxiety and sensitivity problems due to multiple gingival recessions were included in our study. As a randomized controlled clinical trial, in the patients' bilateral recession sites, while gingival recessions of one group were treated with T-PRF, the gingival recessions of the other group were treated with SCTG using a simple randomization method. The study protocol was in accordance with the Declaration of Helsinki of 1975, as revised in 2002 and was submitted to and approved by the ethical committee of Necmettin Erbakan University and the Ministry of Health General Directorate of Health Services (protocol number:2019/238). All patients included in the study were given detailed information about the clinical trial, and their written informed consent was obtained. The study was performed between January 2019 and November 2020 in Necmettin Erbakan University Department of Periodontology.

The individuals were divided into 2 groups in accordance with the study protocol:

Group1: SCTG group (n=60) Group2: T-PRF group (n=58) The criteria for inclusion in the study were determined as systemically and periodontally healthy volunteers between the ages of 18-65, the absence of parafunctional habits, non-smoking, the presence of Miller Class I gingival recession defect in teeth located in the bilateral maxillary region, the absence of any hard tissue defects in the relevant region and the absence of a restorative, endodontic procedure or periodontal surgical intervention, a full-mouth plaque score (FMPS) of ≤ 25%, having a marginal gingival thickness of at least 1 mm in the area with gingival recession, the absence of a shallow hard palate dome, having a soft tissue thickness of at least 3 mm, the absence of torus in the area where the graft was taken, the absence of any systemic disease, not using antibiotics for any reason in the last 6 months, the presence of at least 20 teeth in the mouth, not being pregnant and breastfeeding, and patients who applied to the periodontology clinic with various periodontal problems and were indicated for connective tissue graft operation due to gingival recession. The individuals who were outside the exclusion criteria and did not agree to participate in the study were excluded from the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The criteria for inclusion in the study were determined as systemically and periodontally healthy volunteers between the ages of 18-65,
  • the absence of parafunctional habits, non-smoking
  • the presence of Miller Class I gingival recession defect in teeth located in the bilateral maxillary region
  • the absence of any hard tissue defects in the relevant region and the absence of a restorative, endodontic procedure or periodontal surgical intervention
  • a full-mouth plaque score (FMPS) of ≤ 25%
  • having a marginal gingival thickness of at least 1 mm in the area with gingival recession
  • the absence of a shallow hard palate dome
  • having a soft tissue thickness of at least 3 mm
  • the absence of torus in the area where the graft was taken
  • the absence of any systemic disease
  • not using antibiotics for any reason in the last 6 months
  • the presence of at least 20 teeth in the mouth
  • not being pregnant and breastfeeding, and patients who applied to the periodontology clinic with various periodontal problems and were indicated for connective tissue graft operation due to gingival recession

排除标准

  • The individuals who were outside the exclusion criteria and did not agree to participate in the study were excluded from the study.

结局指标

主要结局

Complete root coverage [ Time Frame: 6 months

时间窗: 6 MONTHS

Change from baseline in gingival recession was be assessed at 1, and 6 months.

Gingival recession depth [ Time Frame: 6 months ]

时间窗: 6 months.

Change from baseline in gingival recession was be assessed at 6 months

次要结局

  • Keratinized tissue width [ Time Frame: 6 months ](6 months.)
  • Pain scores [ Time Frame: first week after operations ](first week)

研究者

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

Dilek Özkan Şen

dr. öğr. üyesi

Necmettin Erbakan University

研究点 (2)

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