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临床试验/NCT03064217
NCT03064217已完成不适用

The Use of Intraoral Imaging at Clinical Crown Lengthening Procedures

University of Maryland, Baltimore4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年5月25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
4
主要终点
Pocket Depth

研究概览

简要总结

Crown lengthening surgery is done when a tooth needs to be fixed with a crown. Sometimes, not enough of the tooth sticks out above the gum to support a crown. This can happen when a tooth breaks off at the gum line, or when a crown or filling falls out of a tooth and there is decay underneath. To place a crown, the dentist needs to expose more of the tooth. This is done by removing some gum tissue or bone.

After surgery, the area will heal in about three months. Then, making a crown can begin. This healing period often delays the delivery a final crown. This study is investing a way to make the final impression at the surgery to expedite the delivery of a final crown.

详细描述

The purpose of this prospective study is to evaluate clinical and radiographic outcomes of single unsplinted fixed restorations made with digital intraoral imaging in conjunction with clinical crown lengthening procedures (CLPs) compared ones fabricated by the conventional protocol.

Specific Aim 1: To evaluate the clinical outcomes between the experimental group (the digital impression taking at clinical crown lengthening procedures) and the control group (the conventional protocol) Hypothesis: There will be no differences in clinical parameters around the teeth between the two groups.

Approach: The investigators will conduct a prospective clinical study and will compare the changes in gingival recession, the width of keratinized gingiva, and pocket depths around the teeth between the two groups.

Specific Aim 2: To evaluate the radiographic outcome between the experimental group and the control group Hypothesis: There will be no difference in crestal bone level around teeth between the two groups.

Approach: The study will investigate the difference in crestal bone level around the teeth at baseline and 12 months between the two groups.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age >18 years
  • a single-unsplinted crown needed
  • the tooth must be in the area from the canine to the second molars
  • a clinical crown lengthening is required to fabricate a crown

排除标准

  • uncontrolled hypertension
  • diabetes mellitus
  • subjects with a history of a long-term use of corticosteroid (> 6 months)
  • subjects with a history of taking oral/IV bisphosphonates within the past 2 years

结局指标

主要结局

Pocket Depth

时间窗: 12 months

Changes in pocket depths (the distance from the gingival margin to pocket base) at 12 months from the baseline

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

Se-Lim Oh

Assistant Professor

University of Maryland, Baltimore

研究点 (4)

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