跳至主要内容
临床试验/NCT07684404
NCT07684404招募中不适用

Effect of Systemic Vitamin D on Dental Implant Osseointegration in Patients With Vitamin D Deficiency: A Randomized Controlled Clinical Study)

Future University in Egypt1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年11月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Treatment of Dental Implant Osseointegration

研究概览

简要总结

The primary goal for any oral implantologist is to obtain satisfactory healing and long-term treatment success. Osseointegration is the key to dental implant success8 and is required to achieve direct structural and functional connection between living bone and the surface of a load-bearing artificial implant, is critical for the long-term success of dental implants.

Successful dental implant therapy relies on achieving proper osseointegration, which ensures a stable structural and functional bond between the implant surface and surrounding bone. Although dental implants show a high overall success rate of around 95%.

详细描述

Implant success depends on several factors surgical and prosthetic factors (surgical technique and operator experience, timing and type of prosthetic loading and quality of pros-thetic rehabilitation), implant-related factors (material, design and surface), and patient-related factors (bone volume/quality at the recipient site and host response.

Despite the high success rate of dental implants, which is reported to be around 95%, failures due to lack of osseointegration remain a significant challenge Implant failures are classified according to the timing of the loss to Early Dental Implant Failure (EDIF) or late dental implant failure (LDIF). Early implant failure occurs due to improper implant placement and restoration, low bone volume or density, systemic conditions, or smoking.

Recent research has indicated that systemic health factors, particularly nutritional status, can significantly influence the process of osseointegration. Vitamin D is a major determinant of mineral homeostasis, promoting intestinal calcium and phosphorus absorption, which are required for optimal mineralization of bone.

Vitamin D also exerts direct actions on bone (probably by regulating the expression of several bone growth factors). It controls mineral metabolism and the bone homeostasis by increasing calcium availability, by regulating PTH secretion, and by direct effects on bone formation and resorption.

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
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 20-60 with diagnosed vitamin D deficiency (<20 ng/mL).
  • Edentulous area in the posterior mandible or maxilla.
  • No history of previous dental implant failure, metabolic bone diseases, or conditions affecting bone healing.
  • Both genders are included

排除标准

  • Severe systemic diseases that could interfere with healing.
  • Patients already on vitamin D or calcium supplements.
  • Smokers or patients with poor oral hygiene practices.
  • Pregnant females

结局指标

主要结局

Treatment of Dental Implant Osseointegration

时间窗: 3 Months

Evaluation of the Primary implant stability measured immediately after implant placement using the Ostell device, which assesses resonance frequency analysis (RFA) values expressed as Implant Stability Quotient (ISQ). This measurement reflects the initial mechanical stability of the implant within the bone at the time of surgery.

marginal bone loss after prosthesis placement

时间窗: six months after proshtesis placement

Marginal bone loss will be evaluated using cone beam computed tomography (CBCT) taken six months after prosthesis placement. The vertical distance between the implant shoulder and the first bone-to-implant contact will be measured on both mesial and distal aspects to assess the amount of peri-implant bone resorption over time.

次要结局

  • Implant Survival Rate(six months after prosthesis placement)

研究者

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

Rana Mohamed Emam Abuhaiba

Researcher of Oral and Dental Medicine

Future University in Egypt

研究点 (1)

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