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临床试验/NCT00641316
NCT00641316已完成不适用

A Prospective Study of Bone Augmentation Techniques in Extraction Sockets and Implant Surface Textures

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2008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
入组人数
41
试验地点
1
主要终点
Bone-fill in Grafted Post-extraction Sockets Versus Bone-fill in Non-grafted Post-extraction Sockets

研究概览

简要总结

When a tooth is extracted the ridge of bone that held the tooth in place begins to heal and over time new bone grows to fill the empty space left by the missing tooth. Sometimes this process works very well and new bone grows to completely fill the socket, at other times new bone fails to fill in the space completely and patients are left with uneven bone-fill.

Grafted extraction sockets may fill with bone faster and more evenly than those without grafts, allowing the dentist to have greater control over the healing process and to repair the area with dental implants in a shorter period of time.

This study will help determine if grafting an extraction socket, with or without enriching the graft material, is an added benefit when compared to allowing the socket to heal naturally.

The study will also assess how well two different dental implant designs used to restore the area will function over time.

详细描述

Tooth extraction is often associated with resorption of the alveolar ridge height and width and with compromised soft tissue contours. A variety of methods have been proposed to overcome varied patterns of post-extraction healing.

An increasingly common practice combines skilled surgical technique with post-extraction site grafting utilizing both natural and synthetic bone-graft materials. These procedures are thought to retard resorption of the socket volume while lending some control over bone-fill - thereby preserving the integrity of the alveolar ridge for future reconstruction with dental implants.

Limited evidence-based data exist to support a variety of bone-graft materials including grafts enriched with autologous platelet-rich plasma(PRP)and grafts enriched with recombinant human platelet-derived growth factors(PDGF). Despite emerging clinical acceptance the most efficacious intervention remains undetermined.

In an effort to establish clinical evidence, this study will assess the efficacy of ridge preservation using three different bone grafting applications in post-extraction sockets compared to extraction alone.

The study will also asses longitudinal success of restoring the study sites with dental implants. Two innovative dental implant designs will be used in the study; an implant with a resorbable blast textured(RBT)surface and an implant with a laser thread-textured (LTT)surface.

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

入选标准

  • •Needed extraction of Maxillary and/or Mandibular Incisors and/or Pre-molar teeth

排除标准

  • •Inability to provide informed consent in English
  • •Pregnant women

研究组 & 干预措施

4 FDBA/TCP + PDGF

Experimental

干预措施: Atraumatic Teeth Extraction/Grafted Extraction Sockets (Procedure)

1

Experimental

Teeth extraction followed by natural healing

干预措施: AtraumaticTeeth Extraction (Procedure)

2- FDBA/TCP

Experimental

干预措施: Atraumatic Teeth Extraction/Grafted Extraction Sockets (Procedure)

3 FDBA/TCP+PRP

Experimental

干预措施: Atraumatic Teeth Extraction/Grafted Extraction Sockets (Procedure)

结局指标

主要结局

Bone-fill in Grafted Post-extraction Sockets Versus Bone-fill in Non-grafted Post-extraction Sockets

时间窗: 2 months

New bone formation in grafted extraction sockets to that of sites healed after 8 weeks of post-extraction.

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

Nicolaas C. Geurs, DDS, MS

Department Chair

University of Alabama at Birmingham

研究点 (1)

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