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临床试验/CTRI/2024/05/067110
CTRI/2024/05/067110尚未招募Unknown

Evaluation of antimicrobial action of healing abutment before and after coating with nanoparticles impregnated with essential oil in type 2 diabetic mellitus- a randomized control trial

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年7月20日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
Expected outcome of the study is that the new nanoparticle coated titanium healing abutment will provides antibacterial and antiadhesive properties against oral early colonizers responsible for biofilm formation. It will decrease the peri-implant mucositis and rate of implant failure.

研究概览

简要总结

Introduction: Dental implants have been validated as a reliable and valid method of replacing lost teeth in recent years, with a primary success rate of roughly 94.6% [1]. Implants are used in nearly every procedure; however, the following specialties fully encompass the use of permanent or temporary biomaterials in combination with metallic and non-metallic materials: ophthalmology, neurosurgery, vascular surgery, orthopaedics, and maxillofacial and cranial surgery.

AIM**:**To evaluate antimicrobial action of healing abutment before and after coating it with nanoparticles impregnated with essential oil.

 OBJECTIVES:

To evaluate growth of staphylococcus aureus, E-coli and Candida albicans on day 0, 1, 7 and 14 after placement of noncoated healing abutment in patients with type 2 diabetes mellitus.

To evaluate growth of staphylococcus aureus, E-coli and Candida albicans at the day on day 0, 1, 7 and 14 after placement of nanoparticles coated healing abutment in patients with type 2 diabetes mellitus.

Comparative evaluation of growth of staphylococcus aureus, E-coli and Candida albicans on day 0, 1, 7 and 14 after placement of noncoated and nanoparticles coated healing abutment in patients with type 2 diabetes mellitus.

Methodology: Total 36 patients with type 2 diabetes mellitus will be included in the study. Patients will be randomly distributed in both the groups i.e. group A and group B. group A will be patients with noncoated healing abutment (n=18) and group B will be patients with nanoparticles coated healing abutment (n=18). For experimental group titanium healing abutment will be precoated with nanoparticles. The healing abutment will be placed in the postgraduate clinic of Department of Prosthodontics and Crown & Bridge. saliva sample (swab collection) will be collected on the day 0, 1, 7 and 14 after placement of healing abutment. Saliva sample will be sent to lab for assessment of growth of staphylococcus aureus, E-coli and candida albicans.

The scope of this study is to develop the new and more effective nanoparticle coated healing abutment, that can decrease the number of bacteria and present more beneficial clinical treatments. It will be more beneficial in patients with diabetes mellitus and other systemic diseases, in which the chances of implant failure and microbial infection is more. It can also improve soft tissue integration, osteo-generation and decreases biofilm formation that leads to decrease in implant failure.

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
45.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients indicated for implant prosthesis 2.Patient with type 2 diabetes mellitus 3.Patients above 18 years of age 4.Patient with good periodontal condition.

排除标准

  • 1.Patient with any systemic disease other than diabetes mellitus 2.Patients on antimicrobial therapy 3.Patient with poor oral hygiene 4.Patient with poor periodontal condition.

结局指标

主要结局

Expected outcome of the study is that the new nanoparticle coated titanium healing abutment will provides antibacterial and antiadhesive properties against oral early colonizers responsible for biofilm formation. It will decrease the peri-implant mucositis and rate of implant failure.

时间窗: 0, 1st, 7th and 14th day

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Pooja Chitlange

Sharad Pawar Dental College

研究点 (1)

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