A Novel Volumetric Analysis Using CAD/CAM Scanners in Gingival Recession
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
- 否
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
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
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
Hacer Sahin Aydinyurt
assistant professor
Yuzuncu Yıl University
