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临床试验/NCT05190614
NCT05190614已完成不适用

Radiographic Evaluation of a Star-shaped Incision Technique for Thick-gingiva and Thin-gingiva Patients Treated With Implant-supported Fixed Prosthesis: a Randomized Trial

Wen Luo1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Papilla height

研究概览

简要总结

To evaluate a star-shaped incision technique to thick-gingiva and thingingiva patients treated with implant-supported fixed prosthesis. The star-shaped incision would be an effective and simple method to reconstruct gingival papillae and avoid the gingival recession in thick-gingiva patients treated with implant-supported fixed prosthesis, and it is worthy of clinical extend.

详细描述

Objective

To evaluate a star-shaped incision technique to thick-gingiva and thin-gingiva patients treated with implant-supported fixed prosthesis. Methods and Materials: 24 patients received cross-shaped incision were assigned into thick-gingiva group (16 cases) and thin-gingiva group (8 cases). Follow-up examination was carried out 3 and 12 months after final restoration. Clinical and radiographic evaluation including gingival papilla height, modified plaque index, modified sulcus bleeding index, periodontal depth, and crestal marginal bone level were utilized.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
22 Years 至 58 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Papilla height

时间窗: Between June 2019 and June 2021

Presence/absence of papilla height was assessed visually according to the papilla index proposed by Jemt

Modified Plaque Index (mPI)

时间窗: Between June 2019 and June 2021

plaque accumulation around the marginal peri-implant tissue was assessed by the criteria of mPI

Modified Sulcus Bleeding Index (mBI)

时间窗: Between June 2019 and June 2021

the bleeding tendency of the marginal peri-implant tissue was evaluated using mBI

Probing Depth (PD, mm)

时间窗: Between June 2019 and June 2021

PD was assessed at the mid-buccal, mid-oral, mesial and distal aspects of the buccal surfaces of each implant with a standard periodontal probe, and final value was determined by the average of four aspects.

Gingival margin level (GML)

时间窗: Between June 2019 and June 2021

gingival margin level was assessed by calculating the vertical distance between the most apical point of gingival margin at the buccal aspect of the crown and line connecting the peak of the adjacent mesial and distal natural teeth (PMD)

The landmarks of first bone-implant contact (fBIC) and implant shoulder (IS)

时间窗: Between June 2019 and June 2021

fBIC-IS was defined as the vertical distance the first bone-implant contact to implant shoulder, and the distance was assessed at the mesial and distal aspect of implant, respectively. When the marginal crestal bone was located coronal to the IS, a positive (+) value was given, where a negative (-) value when located apically to the IS, the value was deemed as zero when IS and fBIC coincided. The crestal bone level at the time of impression taking was regarded as baseline. The known implant length was used for the calibration of dimensional distortion in the radiograph (the length of implant was 10 mm).

次要结局

未报告次要终点

研究者

发起方
Wen Luo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wen Luo

Associate Professor

West China Hospital

研究点 (1)

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