Comparative Assessment of Antimicrobial Effect of Zinc Oxide (ZnO) Nanoparticle Coated Titanium Mini Implants: A Split Mouth Randomized Controlled Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Primary outcome is to evaluate the antimicorobial effectiveness of ZnO nanoparticle coated titanium mini implant
研究概览
简要总结
The Study is a Split Mouth Randomized Controlled Study. Zno Nanoparticle has been used in dentistry in various fields such as Endodontics, Prosthodontics because of its antimicrobial activity. Recently ZnO nanoparticls have been introduced in Orthodontics for coating on orthodontic mini implants. In vitro studies have shown the antimicrobial activity of ZnO Nanoparticle. This study intends to evaluate the clinical efficiency of ZnO nanoparticle coated mini implants against the oral pathogen contributing in mini implant failure. For this study, patients coming to department of orthodontics will be selected as per Convenient, Consecutive, Consenting sampling for their participation in the study. A sample size of 15 patients will be taken (n=15). Two groups will be taken in each patient: Group A (ZnO coated Mini Implant) and Group B ( Uncoated mini implant). SEM and EDS tests will be done prior to placing the mini implant in patients to check the surface characteristics of mini implant. Allocation of mini implants in patient’s mouth either on left or right side will be based on block randomization technique. Swab will be taken on both sides at implant and gingival interface before and after 1 month of insertion. The antimicrobial activity against oral pathogens- 1.Streptococcus mutans 2.Staphylococcus aureus 3. Enterobacter aeruginosa will be checked by counting the colony forming unit per ml for zinc oxide coated and uncoated mini implants sample at baseline (T0) and 4 weeks (T1) intervals . Results will be obtained in the form CFU/ml in tables
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient requiring mini implants placement in their course of orthodontic treatment
- •Site of mini implant placement Buccal placement in Maxillary arch between second premolar and first molar
- •Self drilling type of Titanium Mini implants coated with ZnO nanoparticles
- •Age 16 to 35 years
- •Size Brand Design matched Vector TAS ORMCO1.4×8 mm size.
排除标准
- •Any other medical coating other than ZnO
- •Patients with systemic disease
- •Patients taking any antibiotics upto 3 month prior to mini implant placement
- •Patients taking any antibiotics and corticosteroids during the course of study
- •Patients with habit of smoking and alcohol consumption
- •Pregnant females
- •Periodontally compromised patients
- •Mini implants other than Vector TAS, ORMCO and size 1.4×8 mm.
结局指标
主要结局
Primary outcome is to evaluate the antimicorobial effectiveness of ZnO nanoparticle coated titanium mini implant
时间窗: Outcome will be assessed before insertion baseline and after 4 weeks
次要结局
- retention of zinc oxide nanoparticle coating will be evaluated(after 4 weeks)
研究者
Dr Madhulika Singh
MGM Dental College and Hospital Kamothe Navi Mumbai