跳至主要内容
临床试验/NCT01901783
NCT01901783已完成不适用

Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Plus a Barrier Membrane With and Without Primary Closure

University of Louisville2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Crestal ridge width

研究概览

简要总结

This study is designed to compare the clinical and histologic results of ridge augmentation with and without primary closure over the barrier membrane. The hypothesis is that there will be no difference in crestal ridge width between the two groups.

详细描述

A maximum of 30 patients will be selected that meet the following criteria:

Inclusion Criteria

  1. At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
  2. Healthy person that is at least 18 years old.
  3. Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

  1. Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
  2. Previous head and neck radiation or chemotherapy within the previous 12 months.
  3. Patients with known allergy to any of the materials that will be used in the study.
  4. Smokers.
  5. Patients who need prophylactic antibiotics prior to dental procedures.
  6. Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
  7. Patients who are pregnant.

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

  • At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
  • Healthy person that is at least 18 years old.
  • Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

排除标准

  • Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
  • Previous head and neck radiation or chemotherapy within the previous 12 months.
  • Patients with known allergy to any of the materials that will be used in the study.
  • Patients who need prophylactic antibiotics prior to dental procedures.
  • Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
  • Patients who are pregnant.

结局指标

主要结局

Crestal ridge width

时间窗: 4 months

The ridge width at the crest will be compared between the two treatment groups.

次要结局

  • Percent vital bone(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Henry Greenwell

Professor

University of Louisville

研究点 (2)

Loading locations...

相似试验