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临床试验/NCT07269990
NCT07269990进行中(未招募)1 期

Evaluation of Bone Behavior in Maxillary Post-extractive Sites Treated With Guided Bone Regeneration (G.B.R.) Techniques in Alveolar Socket Preservation (A.S.P.) Procedures With Different Autologous and Heterologous Biomaterials.

University of Foggia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年7月3日最近更新:
干预措施

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
30
试验地点
1
主要终点
Comparison of different biomaterials at 4 months to assess the percentage of residual biomaterial remaining in situ and the percentage of newly formed bone in the regenerated area.

研究概览

简要总结

The maxillary bone atrophies from traumatic, pathological events or related to physiological bone loss after tooth extraction, promoting a decrease in bone volume (vertical-horizontal) which has always been a crucial challenge for the clinician in order to obtain adequate rehabilitations prosthetics.

The results of bone loss induced aesthetic and functional difficulties in achieving surgical and prosthetic rehabilitation of the right dental implant.

Bone loss can be restored with autologous bone grafts and in large bone atrophy of the jaws require complex surgical techniques such as vascularized bone transplantation.

As an alternative to the reconstruction of the maxillary tissue, several surgical techniques have been promoted to prevent or minimize bone resorption through market biomaterials with or without the patient's autologous bone.

To reduce or counteract biological bone resorption, surgeons have promoted alveolar cavity preservation procedures (ASP) with autologous or heterologous graft materials.

Recently, several studies have been published to evaluate the use of demineralized dentin material derived from the extracted tooth to obtain new bone in the maxillary post-extraction site.

The aim of the study is to compare different types of biomaterials 4 months after application through the use of the alveolar socket preservation technique.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy patients.
  • Diagnosis of tooth extraction in the upper or lower jaw.
  • Preservation procedures necessary to preserve jawbone volume with Guided
  • Bone regeneration with autologous or heterologous biomaterials.

排除标准

  • Patients with high risk of receiving the intervention (pre-existing medical conditions/comorbidities/possible adverse events).
  • Patients with conditions that may interfere with the evaluation or confound the results. (e.g. they are already taking treatments)
  • Patients with refusal to participate, inability to provide data, or at high risk of loss to follow-up.
  • Patients with neoplastic pathologies.
  • Patients with Radio-Chemo therapies.

研究组 & 干预措施

compare different types of biomaterials 4 months after application through the use of ASP Group 1

Active Comparator

干预措施: compare different types of biomaterials 4 months after application through the use of ASP compare different types of biomaterials 4 months after application through the use of ASP Group 2 (Procedure)

compare different types of biomaterials 4 months after application through the use of ASP Group 2

Active Comparator

干预措施: Comparison of different types of biomaterials 4 months after application through the use of ASP (Procedure)

compare different types of biomaterials 4 months after application through the use of ASP Group 3

Active Comparator

干预措施: Comparison different types of biomaterials 4 months after application through the use of ASP (Biological)

compare different types of biomaterials 4 months after application through the use of ASP Group 4

Active Comparator

干预措施: The aim is to compare different types of biomaterials 4 months after application through the use of ASP (Procedure)

compare different types of biomaterials 4 months after application through the use of ASP Group 5

Active Comparator

干预措施: The aim is to compare different types of biomaterials 4 months after application through the use of ASP (Procedure)

结局指标

主要结局

Comparison of different biomaterials at 4 months to assess the percentage of residual biomaterial remaining in situ and the percentage of newly formed bone in the regenerated area.

时间窗: 4 months after surgery

次要结局

未报告次要终点

研究者

发起方
University of Foggia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Filiberto Mastrangelo

Clinical Professor, Principal Investigator

University of Foggia

研究点 (1)

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