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临床试验/NCT06246097
NCT06246097已完成不适用

INVESTIGATION of EXPRESSION of C-TERMINAL CROSS-LINKING TELOPEPTIDE of TYPE I COLLAGEN(CTXI) LEVELS IN SALIVA WITH EARLY and DELAYED LOADING of DENTAL IMPLANTS

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年10月10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
40
试验地点
1
主要终点
c terminal telopeptide of type I collagen

研究概览

简要总结

Background:

Implants are commonly used as a treatment choice for partially dentate or in edentulous patients. Currently, no specific biomarker to assess the bone status around the dental implants of healthy patients has been reported to further evaluate bone deposition, resorption and stability. CTX (C-terminal telopeptide) is a known specific biomarker for bone resorption. CTX levels evaluation in serum and urine of patients with bisphosphonates treatment has already been reported. However, its levels in saliva of healthy patients with dental implants has not been investigated, so far.

Objectives:

The aim of this study is to evaluate salivary CTX levels in dental implants with early and delayed loading and to compare it with the values of mechanical stability test (Periotest).

Methods:

Patients coming to OPD of Oral Surgery department of Dow International Dental College (DIDC) and are willing for placement of implant in the posterior molar area of mandible will be enrolled in the study. Informed consent will be taken from each patient for participation in the study. Dental implants placement will be performed according to the standard protocols. All patients will be assessed for implant stability on the day of surgery, at 1 month, 2 month and 3 months by Periotest assessment. Also, saliva will be collected and stored from same patients. Later, ELISA will be performed for expressional analysis of CTX.

详细描述

40 Patients coming to OPD of Dow International Dental College for implant placement in posterior mandible (molar area) will be recruited in the study.

Dental implants available in the Outpatient Department (OPD) of Dow International Dental College (DIDC) will be placed in patients. Dental implants will be placed according to the standard protocols by Dr. Shaheen Ahmed.

Patients will be divided in two groups. Group A patients will be early loaded, and group B will be conventional loaded with prosthesis.

Each patient will be evaluated for implant stability after the surgery, at 1 month, 2 months and 3 months with the help of Periotest.

Saliva will be collected from patients in both the groups before placement of implant and on the same days as of Periotest evaluations after surgery. Saliva will be processed and immediately stored at -80oC. Later sandwich ELISA will be performed for expressional analysis of CTX.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Healthy subjects of age 18 and above.
  • Patients who have consented to be part of the study.
  • Patients in whom only posterior mandibular implants are to be placed.

排除标准

  • • Patients with known bone diseases such as osteoarthritis, osteoporosis etc.
  • Patient with uncontrolled diabetes and uncontrolled hypertension etc.
  • Patients who need maxillary implants.
  • Patients treated with oral cancer.
  • Patients who are given implants in fresh extraction sockets.
  • Patients in whom bone augmentation is needed.

结局指标

主要结局

c terminal telopeptide of type I collagen

时间窗: 3 monts

bone resorption biomarker

次要结局

未报告次要终点

研究者

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

Dania Hamid

Dr. Dania Hamid

Dow University of Health Sciences

研究点 (1)

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