Comparative evaluation of oral microbiome around zinc oxide nanoparticle coated mini implants a split mouth trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- To evaluate the microbiome around zinc oxide nanocoated orthodontic mini implants and to compare the above with an uncoated orthodontic mini implants
研究概览
简要总结
Orthodontic mini implants play an important role in orthodontic treatment as they render absolute skeletal anchorage especially in challenging cases that require high forces such as expansion,distalization,intrusion.Despite high success rate of orthodontic mini implants about a 30 percent of failure rate of mini implants are due to microbial infections and bone inflammation.Generally orthodontic mini implants are additional sites for microorganisms to bind and colonize due to accumulation of dental plaque.
Nanoparticle such as silver,copper,gold, or metal oxides such as titanium oxide , copper oxide, zinc oxide have been researched for antibacterial properties.Among these Zinc oxide has attained considerable attention owing to its anti microbial properties, low cost and stability.
certain studies have evaluated the anti bacterial efficacy of various nanoparticle coated orthodontic mini implants which are mostly in-vitro studies. There is paucity of in-vivo studies comparing the efficacy of nanoparticle coated orthodontic mini implant.therefore these study was designated to evaluate the changes in microbial colonization around zinc oxide nanoparticle orthodontic mini implants.
Patients requiring absolute anchorage and requiring bilateral mini implants will be recruiting for the study.
the following will be group categorization group 1) zinc oxide nanoparticle coated mini implants group 2) uncoated orthodontic mini implants
In each group peri mini implants crevicular fluid will be collected using paper points at the end of 6 months to evaluate microbial concentration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 14.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients undergoing Orthodontic treatment requiring absolute anchorage in the maxillary arch.
- •2.Patients with an oral hygiene index of less than or equal to 3 3.patients with no relavant medical history 4.patients with permanent dentition with full compliment of teeth.
排除标准
- •1.patients with poor oral hygiene 2.patients with extensive dental caries 3.patients with no history of illness or allergies 4.patients with periodontitis and bone loss.
- •5.patients undertaking medications such as antibiotics or anti-inflammatory drugs.
结局指标
主要结局
To evaluate the microbiome around zinc oxide nanocoated orthodontic mini implants and to compare the above with an uncoated orthodontic mini implants
时间窗: (T1) 6 months after mini implant placement
次要结局
- To evaluate the stability of zinc oxide nanoparticle coated mini implants with uncoated mini implants.((T1) 6 months after mini implant placement)
研究者
Jerome Thomas
Sri Ramachandra Institute of Higher Education and Research