跳至主要内容
临床试验/CTRI/2025/07/092061
CTRI/2025/07/092061尚未招募不适用

To comparatively evaluate the presence of microbial leakage at two types of implant abutment connections and adjacent sites of implant

SURENDERA DENTAL COLLEGE AND RESEARCH CENTRE1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
22
试验地点
1
主要终点
THERE WILL BE BACTERIAL COLONY GROWTH IN THE IMPLANT ABUTMENT CONNECTION AND THAT MIGHT LEAD TO FAILURE OF IMPLANT CAUSING PERI IMPLANTITIS

研究概览

简要总结

Dental implants offer a reliable solution for tooth replacement; however, microbial contamination at the implant-abutment interface (IAI) poses a significant risk to their long-term success. A microgap between the implant and abutment in two-part systems can allow the infiltration of fluids and bacteria, including enteric species like Escherichia coli, Klebsiella, and Enterobacter. These bacteria, typically found in the gastrointestinal tract, can colonize peri-implant sites due to poor hygiene or systemic conditions. Their strong biofilm-forming ability and virulence can trigger inflammation, leading to peri-implantitis and bone loss. Recent studies have investigated the characteristics of E. coli in oral infections, examining their virulence, antibiotic resistance, and phylogroups. Additionally, the design and precision of the implant-abutment connection greatly influence microbial leakage, yet comparative data remains limited. Antibiotic therapy, while beneficial, must be used judiciously due to resistance concerns. Maintaining strict oral hygiene remains essential in preventing bacterial colonization. Therefore, this study aims to evaluate bacterial leakage, specifically E. coli, at two different implant systems: once during abutment placement at 3 months and again at 6 months post-implant placement. Adjacent teeth will also be analyzed to better understand bacterial behavior and improve implant design and clinical protocols.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Partially edentulous patients who are cooperative and motivated for dental implant treatment Patients with adequate bone volume Good generalized periodontal health Patient is willing to follow the study protocol.

排除标准

  • Patients with any systemic diseases.
  • Patients having adverse habits tobacco use or smoking, alcohol etc.
  • Pregnant and lactating patients Patients having allergy to the materials to be used during operation.
  • Patients having severe bruxism or clenching.
  • Patient on Immunosuppressed or immunocompromised drugs.

结局指标

主要结局

THERE WILL BE BACTERIAL COLONY GROWTH IN THE IMPLANT ABUTMENT CONNECTION AND THAT MIGHT LEAD TO FAILURE OF IMPLANT CAUSING PERI IMPLANTITIS

时间窗: 9 MONTHS

次要结局

  • IF THERE WILL BE NO BACTERIAL COLONY GROWTH IN THE IMPLANT ABUTMENT CONNECTION THAT MIGHT LEAD TO NON FAILURE OF IMPLANTS
  • IF THERE IS NO BACTERIAL COLONY GROWTH IN THE IMPLANT ABUTMENT CONNECTION THEN THERE WILL BE NO FAILURE OF IMPLANTS(9 MONTHS)

研究者

发起方
SURENDERA DENTAL COLLEGE AND RESEARCH CENTRE
申办方类型
Other [Private Dental college ]
责任方
Principal Investigator
主要研究者

Sagnik Sardar

Surendera Dental College and Research Centre

研究点 (1)

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