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临床试验/NCT05729919
NCT05729919已完成不适用

Healing Dynamics of Free Gingival Grafts; a Colorimetric and Volumetric Assessment

Universitat Internacional de Catalunya2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年2月16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
Volumetric changes of keratinized tissue (KT) around teeth after free gingival graft (FGG).

研究概览

简要总结

Gingival recession on vestibular surfaces of teeth is a frequent occurrence in patients with high standards of oral hygiene, affecting all types of teeth. During the last three decades, several surgical techniques have been proposed to treat single and multiple gingival recessions: pedicled flaps (laterally displaced (CDL) or coronally advanced (ACC) flaps), free gingival grafts (IGL), bilaminar techniques or procedures regenerative.

详细描述

One month before surgery, an interview and periodontal therapy (pre-surgical prophylaxis, oral hygiene instructions and brushing technique teaching) will be carried out.

A digital scan of the arch with the teeth to be treated will be made before the surgery, during the surgery (recipient bed and with sutures), at 6 weeks, 3 months, 6 months and 1 year.

On the day of surgery, the recipient bed will be prepared and a free gingival graft will be taken from the palate to cover the exposed root surface or gain keratinized gingiva.

In terms of aesthetics, morbidity and satisfaction will be evaluated through questions.

At 6 weeks, 3 months, 6 months and 1year, the color of the gum will be evaluated using a spectrophotometer.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female patients between 18 and 90 years old
  • Patients exhibiting deficient KT and indicated for FGG procedure (28)
  • Good systemic health with absence of active periodontal disease
  • Plaque and bleeding index <20%

排除标准

  • Uncontrolled systemic disease
  • Heavy smokers (> 10 cigarettes per day)
  • Restorations that cannot be removed for proper treatment
  • Pregnant or lactant women

结局指标

主要结局

Volumetric changes of keratinized tissue (KT) around teeth after free gingival graft (FGG).

时间窗: 6 weeks, 3 months, 6 months, 1 year

A digital scan of the arch will be performed with an optical 3D measurement system (3Shape Trios) creating STL files. The corresponding reference and follow-up examinations of each clinical case will be virtually overlaid and combined into a common coordinate system (Geomagic, 3D Systems) using the Control X tool. By using of the buccal surfaces of the affected teeth as reference points for the superposition of the different time points

Colorimetric changes of keratinized tissue (KT) around teeth after free gingival

时间窗: 6 weeks, 3 months, 6 months, 1 year

A spectrophotometer (Easy Shade, VITA) will be used for the evaluation of the gingiva color. Before each measurement, the camera will be calibrated. To objectively measure gingiva discoloration, spectrophotometric measurements of the buccal gingiva will be performed on the study and on the adjacent untreated control tooth. The spectrophotometer camera will be positioned perpendicular to the mid-buccal gum and two images will be captured at each site.The center of the area of interest will be located 1.5 mm apical to the mid-buccal gingival margin and 3 mm. The spectral analysis will generate the CIE-Lab (Commission Internationale d'Eclairage) color coordinates L: luminosity, a: chroma along the red-green axis and b: chroma along the yellow-blue axis. The total color difference DE between the gingiva will be calculated according to the formula DE = \[(Limpl Lcontr) 2 + (aimpl acontr) 2 + (bimpl bcontr) 2\] 1/2 (CIE 2004)

次要结局

  • Influence of the volume of an FGG on the contraction of the keratinized gingiva(6 weeks, 3 months, 6 months, 1 year)
  • Influence of the volume of an FGG on the color changes(6 weeks, 3 months, 6 months, 1 year)

研究者

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

Gonzalo Blasi

Principal Investigator Gonzalo Blasi

Universitat Internacional de Catalunya

研究点 (2)

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