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临床试验/NCT06221306
NCT06221306招募中不适用

Radiographic Evaluation of Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants in Conjunction With Bone Augmentation in Horizontally Deficient Posterior Mandibular Partially Edentulous Sites: A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年2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
招募中
入组人数
28
试验地点
1
主要终点
Amount of crestal bone changes

研究概览

简要总结

Dental implant treatment, in many cases, may be impeded by anatomical limitations, such as narrow atrophic ridges. In order to overcome that, additional surgical procedures, such as guided bone regeneration, are often required to augment the deficient hard tissue. However, additional surgical procedures often add morbidity to the patient in addition to prolonging the treatment time and raising the treatment cost.

Hence, simpler, less invasive treatment options are preferred by patients. The use of narrow diameter implants (NDI) offers the great advantage of eliminating the need for augmentation procedures.

详细描述

Various methods of additional surgical procedures have been introduced to overcome reduced bone volume situations, relevant to the site, size and nature of the defect such as: maxillary sinus floor lifting and augmentation, vertical and lateral ridge augmentation by means of autogenous or bone substitutes, particulate or blocks. Lateral bone augmentation performed simultaneously with implant placement has been a well-established treatment option for horizontal ridge deficiencies.

Such additional procedures are associated with longer surgical time, greater morbidity and greater risk to complications such as: pain, infection, nerve damage, bleeding, wound dehiscence or even graft or implant failure. In addition to, higher treatment cost and a longer healing time. Furthermore, an additional surgical procedure should be considered with caution in medically compromised patients. Moreover, surgical expertise of the operator is required for performing such procedures.

NDIs showed promising results with reported survival rates 95% - 100%. However, prosthetic complications such as: abutment fracture, loss of crown retention and screw loosening were reported.

The successful outcomes of NDI have supported widening the scope to include premolars and molars, particularly where averting an additional augmentation procedure is favoured.

However, areas of concern remain evident regarding; the impact of loading on a reduced surface for osseointegration, the increased probability of fracture, the probable prosthetic complications and the loading stresses affecting crestal bone resorption. In addition to oral health-related quality of life for the patients. Limited literature is found regarding the use of NDI to restore posterior mandibular edentulous sites.

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

  • Patients having mandibular edentulous posterior site requiring implant placement.
  • Available vertical bone height of ≥ 8 mm in the mandible and ridge width 5-6 mm in width.
  • Tooth extraction ≥3 months before surgical intervention.
  • Patients without systemic diseases interfering with implant therapy.
  • Patients aged ≥ 18 years old.
  • Good oral hygiene.

排除标准

  • Patients with systemic conditions known to affect bone metabolism and healing
  • Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits.

研究组 & 干预措施

Narrow diameter implant placement (NDI) (3.3)

Experimental

干预措施: Dental implant: NDI (Procedure)

Standard diameter implant (SDI) placement (4.1) with simultaneous bone augmentation.

Active Comparator

干预措施: Dental implant: SDI (Procedure)

结局指标

主要结局

Amount of crestal bone changes

时间窗: 1 year

Linear measurements (in mm) for the crestal bone level changes on periapical digital radiographs

次要结局

  • Prosthetic complications(1 year)

研究者

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

Suzy Nabil Naiem

Periodontist

Cairo University

研究点 (1)

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