跳至主要内容
临床试验/NCT03635931
NCT03635931已完成不适用

Efficiency of Concentrated Growth Factor in the Surgical Treatment of Multiple Adjacent Papillary Losses: a Controlled, Examiner-blinded Clinical Study

Gazi University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年7月30日最近更新:
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
40
试验地点
2
主要终点
change in the percentage of papillary fill(PF)

研究概览

简要总结

The aim of this study was to evaluate the efficacy of concentrated growth factor (CGF) in applied in the regenerative treatment of multiple adjacent papillary black triangles (MAPBT) occured as a result of soft tissue loss. Interdental papillary regeneration was evaluated with the change in the area of interproximal spaces calculated on each of the intraorally scanned images obtained with digital impressions of the interproximal space with irregular borders.This controlled, examiner-blinded, clinical study included of 40 patients with 120 open embrasures which resulted from papillary loss in adjacent teeth in the anterior maxillary esthetic zone resulting in black triangles (BTs). Then patients were randomly assigned to receive surgical regenerative periodontal treatment(test) or periodontal care(control)The test group was formed of 20 patients with 60 adjacent papillary defects . A control group was formed of 20 patients with 60 adjacent papillary defects.. A total of 480 images obtained with the digital impressions . Evaluations of the test group were made preoperatively and at 3, 6 and 12 months postoperatively. For the control group, oral hygiene instruction was provided. Control group is evaluated by the same procedure with test group but the surgical part is not performed. Lost interdental papillary area (PA)were calculated. In the test group, the percentage of papillary filling, the presence of keratinized gingiva, the thickness of papillary gingiva, blood thrombocyte count and mean platelet volume values(MPV) were recorded.

详细描述

The treatment of open gingival embrasures, which are also known as black triangles (BT) or black holes, and cause esthetic, functional and phonetic problems in the anterior region, has become an area of interest in current periodontal treatment.Surgical, non-surgical and prosthetic methods are applied in the treatment of BT, which can be seen in more than half of adults. This study aimed to evaluate the efficacy of concentrated growth factor (CGF) in regenerating interdental papillary of multiple adjacent papillary black triangles (MAPBT) occured as a result of soft tissue loss. Interdental papillary regeneration was evaluated with the change in the area of interproximal spaces calculated on each of the intraorally scanned images obtained with digital impressions of the interproximal space with irregular borders.

This controlled, examiner-blinded, randomized clinical study included 160 teeth of 40 patients with 120 open embrasures which resulted from papillary loss in adjacent teeth in the anterior maxillary esthetic zone resulting in black triangles (BTs). The test group was formed of 20 patients with 60 adjacent papillary defects undergoing minimally invasive surgery for papillary regeneration with CGF. A control group was formed of 20 patients with 60 adjacent papillary defects who were not included surgical treatment. A total of 480 images obtained with the digital impressions method of each interdental papillary region in each patient were uploaded to a special software. Evaluations of the test group were made preoperatively and at 3, 6 and 12 months postoperatively. For the control group, oral hygiene instruction was provided. Control group is evaluated by the same procedure with test group but the surgical part is not performed. Lost interdental papillary area (PA)were calculated between the two central teeth, between the lateral and central teeth, and between the lateral and canine teeth prior to the treatment and at pro-treatment periods of 3, 6 and 12 months in both of the groups. In the test group, the percentage of papillary filling, the presence of keratinized gingiva, the thickness of papillary gingiva, blood thrombocyte count and MPV values were recorded.

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
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of interdental papillary losses in the maxillary anterior teeth, between the adjacent central teeth, the central and lateral teeth and the lateral and canine teeth
  • The presence of a contact point in the maxillary anterior teeth
  • optimal facial keratinized gingiva/ keratinized gingiva must be more than 2mm

排除标准

  • pregnancy or
  • breast-feeding,
  • palatal and gingival recession,
  • attachment loss,
  • high labial frenulum.

研究组 & 干预措施

Concentrated Growth Factor

Active Comparator

plaque control, scaling and root planing if required, surgical application of CGF

干预措施: Concentrated Growth Factor (Procedure)

Control Group

No Intervention

plaque control, scaling and root planing if required

结局指标

主要结局

change in the percentage of papillary fill(PF)

时间窗: Change from 3 months percentage of papillary fill at 6 months

The percentage of PF was also calculated as (\[ Lost Papillary area(PA) preoperation - PA postoperation\] / PA preoperation) x 100%.

次要结局

未报告次要终点

研究者

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

Zeynep Turgut Çankaya

Principal Investigator

Gazi University

研究点 (2)

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