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临床试验/CTRI/2025/07/090745
CTRI/2025/07/090745尚未招募不适用

Comparative evaluation of systemic use of liposomal curcumin versus autologous exosomes in healing of fresh extraction socket- A randomize controlled study

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Soft tissue healing assessed using Landry, Turnbull & Howley Healing Index at Day 7, Week 4, and Week 8

研究概览

简要总结

)Title of the Study/Project : compararative evaluation of systemic use of liposomal curcumin versus autologous exosomes in healing of fresh extraction socket - Randomised controlled study .

ii)Aims and methods of the research. To evaluate and compare the effectiveness of systemic liposomal curcumin and autologous exosomes in enhancing soft and hard tissue healing of fresh extraction socket in healthy individuals.

iii)Expected duration of the subject participation : 7 days after the post extraction.

iv)The benefits to be expected from the research to the subject or to others : relief from postoperative healing and inflammation following surgical extraction .

v)Any risk to the subject associated with the study : no

vi)Maintenance of confidentiality of records : yes

vii)Provision of free treatment for research related injury : yes

viii)Compensation of subjects for disability or death resulting from such injury: yes

ix)Freedom of individual to participate and to withdraw from research at any time without penalty or loss of benefits to which the subject would otherwise be Entitled : yes

x)Amount of blood sample in quantity, in Tea Spoon Full, to be taken should be mentioned : around 5 ml of blood.

ix)Freedom of individual to participate and to withdraw from research at any time without penalty or loss of benefits to which the subject would otherwise be Entitled : yes

x)Amount of blood sample in quantity, in Tea Spoon Full, to be taken should be mentioned :

around 5 ml (for CBC )

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 to 50 years Medically healthy Indicated for non infected, single tooth extraction Non smokers or light smokers less than five cigarettes per day Willing to provide written informed consent and comply with follow up schedule.

排除标准

  • 未提供

结局指标

主要结局

Soft tissue healing assessed using Landry, Turnbull & Howley Healing Index at Day 7, Week 4, and Week 8

时间窗: Duration of study- 3 months

次要结局

  • Postoperative pain using Visual Analog Scale (VAS) Radiographic bone healing assessed via IOPA or CBCT at 4 & 8 weeks(Week4 ,week8)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr. Nitin bhagat

Manav rachna international institute of research and science

研究点 (1)

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