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临床试验/NCT04185987
NCT04185987已完成不适用

Evaluation of the Contamination of Elastomeric Ligatures

University of Gaziantep1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年8月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Microbial colonisation change of S mutans

研究概览

简要总结

This crossover, in-vivo study was carried out with 10 patients who have been started to be treated at Orthodontics Department. 3 elastomeric ligatures were examined in terms of microbiological and surface roughness.

详细描述

The development of dental plaque has been associated with several environmental and individual factors including diet composition, oral hygiene, the quality of saliva, the composition of the oral microflora and immune factors. Orthodontic fixed appliances also impede the maintenance of oral hygiene. Plaque accumulation surrounding orthodontic appliances leads to enamel demineralization caused by organic acids produced by bacteria in the dental plaque.

In patients with fixed orthodontic treatment, common pathological changes are gingivitis, bleeding and gingival growth; thus, gingival index and plaque index parameters have been used as indicators of periodontal disease in many studies. Enamel demineralization which results in white spot formation is observed due to the increase in the number and volume of acid-producing bacteria, and the decrease in pH level because of the glucose metabolized by these cariogenic bacteria . The most commonly investigated bacteria among those mentioned above is Streptococcus Mutans. In the literature, it has been the subject of many studies, including those investigating the correlation between the S. mutans count and the amount of adhesive left between brackets and the enamel, adhesion of S. mutans to nickel titanium and copper-nickel brackets, the difference in S. mutans colonization between self-ligation system and normal brackets, and the effect of elastomeric rings and ligature wires on S. mutans colonization.

Non-conventional elastomeric ligatures were produced in order to reduce the friction of orthodontic sliding mechanics. Manufacturers claim that non-conventional elastomeric ligatures reduced ligation friction by 60% compared to conventional modules. It was reported in another study that brackets combined via non-conventional elastomeric ligatures resulted in a reduced friction force compared to conventional elastomeric ligatures in any wires from 14-inch NITI to 19.25 SS.

To our current knowledge, bacterial colonization on non-conventional elastomeric ligatures was investigated in one study only, using microbial culture technique. In light of this information, present study was aimed to compare S. mutans colonization among different commercial types of non-conventional ligatures and ligature wires. The surface structures of these ligature types also will be investigated by atomic force microscope (AFM) and the results of this investigation will be associated with the results of bacterial colonization amount.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •permanent teeth in the mouth
  • •patients with good oral hygiene
  • •patients did not use antimicrobial drugs such as antibiotics and mouthwashes 3 weeks before the study period and within the 18-week period covering the study period.

排除标准

  • 未提供

研究组 & 干预措施

Microbial colonisation

Experimental

microbial sample collection was done at the end of the time periods T1 (6 weeks after bonding ), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)

干预措施: Leone slide low friction elastomeric ligature (Other)

Microbial colonisation

Experimental

microbial sample collection was done at the end of the time periods T1 (6 weeks after bonding ), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)

干预措施: RMO tough - o energy elastomeric ligature (Other)

Microbial colonisation

Experimental

microbial sample collection was done at the end of the time periods T1 (6 weeks after bonding ), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)

干预措施: Dentsply sili tie elastomeric ligature (Other)

Microbial colonisation

Experimental

microbial sample collection was done at the end of the time periods T1 (6 weeks after bonding ), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)

干预措施: AO twisted ended ligature wire (Other)

Plaque index

Experimental

Plaque index was measured prior to bonding (T0), 6 weeks after bonding (T1),10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)

干预措施: Leone slide low friction elastomeric ligature (Other)

Plaque index

Experimental

Plaque index was measured prior to bonding (T0), 6 weeks after bonding (T1),10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)

干预措施: RMO tough - o energy elastomeric ligature (Other)

Plaque index

Experimental

Plaque index was measured prior to bonding (T0), 6 weeks after bonding (T1),10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)

干预措施: Dentsply sili tie elastomeric ligature (Other)

Plaque index

Experimental

Plaque index was measured prior to bonding (T0), 6 weeks after bonding (T1),10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)

干预措施: AO twisted ended ligature wire (Other)

Gingival index

Experimental

Gingival index was measured prior to bonding (T0), 6 weeks after bonding (T1), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)

干预措施: Leone slide low friction elastomeric ligature (Other)

Gingival index

Experimental

Gingival index was measured prior to bonding (T0), 6 weeks after bonding (T1), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)

干预措施: RMO tough - o energy elastomeric ligature (Other)

Gingival index

Experimental

Gingival index was measured prior to bonding (T0), 6 weeks after bonding (T1), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)

干预措施: Dentsply sili tie elastomeric ligature (Other)

Gingival index

Experimental

Gingival index was measured prior to bonding (T0), 6 weeks after bonding (T1), 10 weeks after bonding (T2), 14 weeks after bonding (T3), 18 weeks after bonding (T4)

干预措施: AO twisted ended ligature wire (Other)

surface roughness

Experimental

surface roughness was measured before usage and after 4-weeks usage

干预措施: Leone slide low friction elastomeric ligature (Other)

surface roughness

Experimental

surface roughness was measured before usage and after 4-weeks usage

干预措施: RMO tough - o energy elastomeric ligature (Other)

surface roughness

Experimental

surface roughness was measured before usage and after 4-weeks usage

干预措施: Dentsply sili tie elastomeric ligature (Other)

surface roughness

Experimental

surface roughness was measured before usage and after 4-weeks usage

干预措施: AO twisted ended ligature wire (Other)

结局指标

主要结局

Microbial colonisation change of S mutans

时间窗: up to 18 weeks

Measurement of microbial colonisation change of the interventions with real time PCR

surface roughness identification with atomic force microscope

时间窗: up to 4 weeks

measurement of surface roughness identification of the interventions by atomic force microscope

次要结局

  • Plaque index(through study completion, 18 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aysegul Gulec

Principal investigator

University of Gaziantep

研究点 (1)

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