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临床试验/NCT03763617
NCT03763617Unknown不适用

Periosteal Inhibition Technique for Ridge Preservation A Prospective Study

Clinique Dentaire et d'implantologie Dr.Vinh Nguyen0 个研究点目标入组 40 人开始时间: 2018年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
主要终点
Ridge widths

研究概览

简要总结

The efficacy of the Periosteal Inhibition technique for socket preservation is studies against a control group in which the extraction sockets are allowed to heal without a socket preservation procedure.

详细描述

Socket preservation procedures have been shown to significantly reduce the loss of ridge dimension of an extraction socket. These procedures involve filling the empty socket with a bone graft material, which, serves as scaffold to limit horizontal and vertical ridge alterations. In order to contain the graft material, an occlusive barrier such as an autogenous soft tissue graft, resorbable or non-resorbable membrane, is often required. As yet, no one socket preservation technique has been proven superior to another, and none have proven totally effective in preserving ridge morphology. A net reduction of 1.5 mm in ridge width and 0.5 mm in ridge height is often observed after socket preservation procedures, which may necessitate additional hard or soft tissue augmentation to fully restore the ridge dimension.

In an animal histologic study in 2005, Araujo and Lindhe demonstrated that trauma and loss of periodontal ligament triggered an osteoclastic activity causing loss of bundle bone and modeling of the cortical bone plate. Osteoclasts are multi-nucleated cells that are responsible for bone resorption and are found on the outer layer of bone, beneath the periosteum. Osteoclasts are thought to be derived from pluripotent hematopoietic stem cells. When stimulated, these mononuclear precursors, the smallest of which is 9.5 microns in diameter, proliferate and attach to the bone surface to be resorbed, and only then fuse to form large mature multinucleated osteoclasts.

High-density polytetrafluoroethylene (d-ptfe) membranes have been used in socket preservation procedures as an occlusive barrier to contain the bone graft material.Polytetrafluoroethylene, a stable polymer and highly biocompatible, has a membrane porosity of less than 0.3 microns. It is impervious to bacteria and thus is recommended for a socket preservation technique, where a membrane is intentionally exposed.

In the present study, a high-density polytetrafluoroethylene (d-ptfe) membrane is placed between the periosteum and the buccal bone plate of an extraction socket where it will stay for a duration of 4 months, the time needed for the completion of bone forming within the socket. The goal of the non-resorbable d-ptfe membrane is to prevent the migration of precursor cells to the bone surface and thus their fusion to form osteoclast. The authors hypothesize that the passage of the precursor cells from the periosteum to the bone surface is inhibited by the small-diameter pores in the non-resorbable d-ptfe membrane. Osteolytic activity on the outer surface of the socket is thereby prevented as the precursor cells cannot form osteoclasts. The author coins the term "Periosteal Inhibition technique" for this socket preservation procedure.The study will compare dimension changes between extraction socket treated using the Periosteal Inhibition technique and those allowed to heal without a socket preservation procedure.

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
Double (Participant, Investigator)

入排标准

年龄范围
22 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 22 years of age
  • Systemically healthy
  • An extraction of one non-salvageable molar or premolar tooth is indicated. Adjacent teeth must be present to support the measuring template.
  • Demonstrated ability to maintain goodoral hygiene
  • Willingness and ability to commit to follow-up
  • Able to understand study procedure and provide signed informed consent.

排除标准

  • Extensive damaged buccal or lingual bone plate
  • Extreme alveolar ridge atrophy
  • Extensive vertical bone loss
  • Active infection at the extraction site
  • Uncontrolled periodontal disease.
  • Recent febrile illness (within 6 months) that precludes or delays participation
  • Severe renal or liver diseases
  • History of radiotherapy of the head and neck region
  • Chemotherapy for treatment of malignant tumors at the time of the study.
  • Immuno-compromised patients
  • Patients on IV bisphosphonates or on long term oral bisphosphonates for more than 3 years.
  • Use of disallowed concomitant medications.
  • Pregnancy or intending to conceive during the course of the Study.

研究组 & 干预措施

Test group

Active Comparator

A d-ptfe membrane will be placed between the buccal bone and periosteum of an extraction socket during a 4 months healing time before it is surgically removed.

干预措施: d-ptfe membrane (Device)

Control group

No Intervention

The extraction socket will be left to heal naturally without a socket preservation intervention.

结局指标

主要结局

Ridge widths

时间窗: 0 hour and 4 months

Bucco-lingual ridge dimensions at the midline is measured at 3mm and 5mm apical to the gingival margin, at the time of extraction intra-op and 4 months post-extraction, using a acrylic template for repeatable measurements.

Change in Ridge heights

时间窗: 0 hour and 4 months

Change in Ridge bone heights at messiah and distal interproximal, mid-buccal and mid-lingual aspects.

Change in Ridge widths on the buccal and lingual aspects

时间窗: 0 hour and 4 months

Buccal and lingual ridge dimension change at the midline is measured at 3mm and 5mm apical to the gingival margin, at the time of extraction and 4 months post-extraction, using a acrylic template for repeatable measurements.

次要结局

  • Bone plate thickness(0 hour)
  • Keratinized mucosa(0 hour and 4 months)

研究者

发起方
Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vinh Giap Nguyen, DDS

Principal investigator

Clinique Dentaire et d'implantologie Dr.Vinh Nguyen

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