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临床试验/NCT03295604
NCT03295604已完成不适用

A Novel Volumetric Analysis Using CAD/CAM Scanners in Gingival Recession

Hacer Sahin Aydinyurt0 个研究点目标入组 35 人开始时间: 2014年4月1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
发起方
入组人数
35
主要终点
GRH

研究概览

简要总结

Aim: In this ramdomised clinical trial (RCT), the aim was to compare clinical periodontal data of subepithelial connective tissue graft (SCTG) group and SCGT+enamel matrix derivatives (EMD) group in terms of gained gingiva volume (GGV) and gained gingiva surface area (GGSA) by scanners of computer-aided design/computer-aided manufacturing (CAD/CAM) devices.

Materials and Methods: A total of 35 Miller class I-II gingival recession defects were involved in this study (n=17 in SCTG group, n=18 in SCTG+EMD group). In addition to periodontal clinical parameters, three dimensional (3D) images were recorded using CAD/CAM system before the treatment, at the 1st month and at the 6th months after the treatment. The images were superimposed using softwares and GGV, GGSA were calculated.

详细描述

Study populations:

In this study, totally 35 gingival recession (GR) defects in 35 patients, who applied with complaints of poor aesthetic and/or root surface sensitivity. Following patients were admitted to the study: individuals should have no systemic disease, should be non-smokers of cigarette or tobacco products, not in a pregnancy, have not used any antibiotics or medications with an impact on the immune system within last 6 months, have GR classified as Miller class I or class II, have GR depth of ≥2mm , have no decay or restoration on the vital teeth which will be operated, have no operation history with regard to GRs for related tooth area. The materials and methods of this study were approved by the Non-Drug Clinical Researches Ethics Committee of Yüzüncü Yıl University (B.30.2.YYU.0.01.00.00/32).

Study Groups:

In SCTG group 17 of GRs defects and in SCTG+EMD group 18 GRs defects were treated. While GRs in SCTG group was treated by SCTG and CPF combination therapy, EMD (Emdogain, Straumann, Basel, Switzerland) was additionally used in GR treatments of SCTG+EMD group. Patients were randomized by complete randomization method (SPSS 15; SPSS Inc., Chicago, IL, USA) to assign them into groups.

Pre-surgical Procedure:

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
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • individuals should have no systemic disease
  • non-smokers of cigarette or tobacco products
  • not in a pregnancy,
  • have not used any antibiotics or medications with an impact on the immune system within last 6 months,
  • have GR classified as Miller class I or class II
  • have GR depth of ≥2mm ,
  • have no decay or restoration on the vital teeth which will be operated
  • have no operation history with regard to GRs for related tooth area.

排除标准

  • pregnancy
  • Miller class III and IV gingival recession
  • antibiotic use

研究组 & 干预措施

test group

Experimental

Miller class I-II gingival recession defects operated with sub epithelial connective tissue graft (SCTG) in addition with enamel matrix derivatives (EMD) (Emdogain ®, Switzerland ) in SCTG+EMD group.

干预措施: SCTG+EMD (Procedure)

control group

Experimental

Miller class I-II gingival recession defects operated with only sub epithelial connective tissue graft (SCTG). No drug or something else were used

干预措施: SCTG (Procedure)

结局指标

主要结局

GRH

时间窗: 6 months

gingival recession height: the distance between cementoenamel junction to gingival margin (mm)

GGSA

时间窗: 6 months

Gingival gain of surface area: measured by software on images (mm2

GGV

时间窗: 6 months

Gingival gain volume: measured by software on images (mm3)

GRW

时间窗: 6 months

gingival recession width: the distance between mesial and distal gingival margins (mm)

次要结局

未报告次要终点

研究者

发起方
Hacer Sahin Aydinyurt
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hacer Sahin Aydinyurt

assistant professor

Yuzuncu Yıl University

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