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临床试验/CTRI/2025/03/082315
CTRI/2025/03/082315尚未招募2/3 期

To comparative evaluation of the effect of local application of somatropin growth hormone on osseointegration and bone density around dental implant clinical and radiographic study

Dr Sonal Kumbare1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年3月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
Primary outcome of the Study-

研究概览

简要总结

This study will assess the effect of locally applied somatropin growth hormone on osseointegration and bone density around dental implants. The study will be done in an edentulous patient with healthy bony ridges in both the maxillary and mandibular arches. Somatropin growth hormone will be applied locally in the osteotomy site before implant placement. Results will be assessed by CBCT evaluation. Results are expected to show enhanced implant stability, faster healing, and increased bone density in the experimental group compared to controls. Somatropin demonstrated potential as a valuable adjunct in improving dental implant outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA (American Society of Anesthesiologists) 1 patient indicates that the patient is a "normal healthy patient" with no systemic disease, a non-smoking individual, and without any significant health issues that would increase the risk of anesthesia or surgical procedures
  • Patient with completely or partially edentulous arches.
  • Patients with adequate bone volume for placement of dental implant.
  • All women with natural menopause and no previous fractures.
  • Patients of the age group between 18 to 60 years of age Patients willing to participate in the study by giving a written consent form ASA (American Society of Anesthesiologists) 1 patient indicates that the patient is a "normal healthy patient" with no systemic disease, a non-smoking individual, and without any significant health issues that would increase the risk of anesthesia or surgical procedures.Patient with completely or partially edentulous arches.
  • Patients of the age group between 18 to 60 years of age Patients willing to participate in the study by giving a written consent form.

排除标准

  • General contraindication to dental implant treatment (uncontrolled diabetes, severe cardiovascular diseases, osteoporosis, and infectious diseases).
  • Patients with a habit of smoking and alcohol consumption.
  • Patients with inadequate bone volume for implant placement.

结局指标

主要结局

Primary outcome of the Study-

时间窗: time interval between 3 months 6 months and then 6 months

The primary expected outcome of the study is improved osseointegration and

时间窗: time interval between 3 months 6 months and then 6 months

bone density in dental implants in patients treated with Human-recombinant Somatropin growth hormone (4 iu).

时间窗: time interval between 3 months 6 months and then 6 months

次要结局

  • The secondary expected outcome of the study is enhanced bone implant contact due to the application of Humanrecombinant Somatropin growth(hormone 4iu)

研究者

发起方
Dr Sonal Kumbare
申办方类型
Other [Government dental college Raipur 492001 India]
责任方
Principal Investigator
主要研究者

Sonal Kumbare

Government Dental Cillege Raipur

研究点 (1)

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