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临床试验/NCT06302322
NCT06302322已完成不适用

Influence of Mucosal Tissue Height on Implant Crestal Bone Stability: A Longitudinal 10-year Cohort Study

Harvard Medical School (HMS and HSDM)2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2021年1月7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
59
试验地点
2
主要终点
Crestal Bone Levels

研究概览

简要总结

Our study looks into how the thickness of the gum tissue affects the health of the bone around dental implants over ten years. We include 59 people and divide them into three groups based on their gum tissue thickness. Some have naturally thin gums, some have thin gums that were made thicker with a special procedure, and some already had thick gums. We try to find out if having thicker gums, whether naturally or through enhancement, can help keep the bone around dental implants healthy in the long run.

详细描述

The protocol of our study focuses on understanding the impact of gum tissue thickness on the stability of the bone surrounding dental implants over a period of ten years. We enroll 59 participants and categorize them based on their initial gum thickness. The study groups included participants with naturally thin gums, participants whose thin gums were surgically enhanced with an allogenic tissue matrix to increase thickness, and participants with naturally thick gums. We monitore the bone levels around the implants using X-rays at baseline and annually, assessing any changes in bone health and stability. Our objective is to determine if and how the thickness of gum tissue influences long-term bone preservation around dental implants, aiming to provide insights into better implant care and outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The inclusion criteria for the study were individuals aged 18 years or older, generally healthy with no medical contraindications for implant surgery, missing teeth in the lower jaw posterior area, at least 6 mm bone width, healthy soft tissue, at least 2 mm keratinized gingiva buccally and lingually, no bone augmentation procedures before or during implant placement, and a signed informed consent form. The

排除标准

  • included poor oral hygiene, history of uncontrolled periodontitis, smoking, diabetes, alcoholism, and medication influencing healing.

结局指标

主要结局

Crestal Bone Levels

时间窗: 10 year follow up

Assessment of changes in crestal bone level (CBL)

次要结局

  • PPD(10 year follow up)
  • BOP(10 year follow up)
  • PI(10 year follow up)

研究者

发起方
Harvard Medical School (HMS and HSDM)
申办方类型
Other
责任方
Principal Investigator
主要研究者

German O. Gallucci

Associate Professor and Chair Department of Restorative Dentistry and Biomaterials Sciences

Harvard Medical School (HMS and HSDM)

研究点 (2)

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