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临床试验/NCT05505084
NCT05505084已完成不适用

Comparison of Five Distinct Membranes for Preservation of the Alveolar Ridge Following Tooth Extraction: A Prospective, Randomized, Controlled Clinical Study

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2022年8月15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
47
试验地点
2
主要终点
Ridge dimension changes before and after the augmentation.

研究概览

简要总结

Bone resorption after a tooth extraction is a generally accepted knowledge and has been demonstrated by many animal and human studies. Especially during the first three months followed by the tooth extraction, the volume of bone may change significantly without any interference. Thus, doing a ridge preservation procedure following the extraction is a common standard of care method to maintain the socket volume if implant placement is considered as a treatment option in the future. A variety of materials and methods have been used for ridge preservation. However, it's still inconclusive to determine the best material to maintain the ridge dimension, especially for membrane placement that allows for space maintenance to protect the grafting material. Furthermore, there is no evidence to show any treatment rationale is superior to any other ridge preservation method.

In general, the membrane serves the function of the barrier and space protector. The periodontal surgeon use membranes to exclude the epithelium growth and to limit the collapse of the soft tissue into the healing alveolar socket. Regarding resorbable and non-resorbable membrane materials, both serve the function of protecting the graft material from the oral cavity. However, there are also many demonstrating that without membranes the extraction socket healed nicely without any interferences. The question to us is: Do we need the membrane to exclude the epithelium or any kind of surgical dressing material is sufficient enough to preserve the volume of the extracted ridge?

The object of this study is to compare five popular membranes on the market that present different characteristics of the membranes.

详细描述

The extraction and the grafting procedure involved in this study are standard of care. The investigators will extract the hopeless teeth and prepare the site for implant placement in 4 months.

The following products will be used during the study:

  • Collatape (Zimmer Dental)- approved by the FDA (class III)
  • Cytoplast (Osteogenics Biomedical)- cleared by the FDA
  • OssixPlus (Dantum Dental)- cleared by the FDA
  • Renovix-Plus (Salvin)- cleared by the FDA
  • BioXclude (SNOASIS)-certificate from the American Association of Tissue Banking
  • PuroⓇ, Zimmer Dental)- cleared by the FDA
  • RegenerOssⓇ, Zimmer Dental) - cleared by the FDA

During the appointment for the implant placement. A bone core from all subjects in each treatment group will be collected from the augmentation site instead of drilling away. The sample will be evaluated for the following:

  • % viable of bone
  • % of connective tissue
  • % of residual graft material

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Subjects must between the ages of 18 and
  • Subjects must require removal of at least one maxillary premolar
  • Subjects should benefit from an implant-supported crown.
  • Subjects must have voluntarily signed the informed consent form.
  • Subjects must be assessed as ASA I, ASA II by a member of the research team.

排除标准

  • Medical conditions requiring the use of steroids.
  • History of leukocyte dysfunction or deficiencies, bleeding deficiencies, renal failure, uncontrolled endocrine disorders, acquired immunodeficiency syndrome or hepatitis.
  • History of neoplastic disease requiring the use of chemotherapy or irradiation to head and neck.
  • Subjects who have diabetes mellitus.
  • Subjects who have undergone administration of any investigational drug or device within 30 days of enrollment in the study.
  • Alcohol or drug abuse.
  • Subjects who are heavy smokers (greater than 10 cigarettes per day or cigar equivalents) or chew tobacco.
  • Conditions or circumstances, in the opinion of the research team, which would prevent completion of study participation or interfere with analysis of study results, such as a history of non-compliance or unreliability.

结局指标

主要结局

Ridge dimension changes before and after the augmentation.

时间窗: from the date of the extraction 4 months

The change in alveolar ridge dimensions will be assessed using CBCT technology after extraction and 4 months after extraction.

Histological Evaluation

时间窗: 4 months post-augmentation

A bone core from all subjects in each treatment group will be taken from the augmentation site at the time of implant placement (4 months post-augmentation) and will be evaluated for the composition of the specimen.

次要结局

  • Implant site conditions(4 months post-augmentation)

研究者

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

Yucheng Chang

Director of Predoctoral Periodontics

University of Pennsylvania

研究点 (2)

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