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临床试验/NCT02436525
NCT02436525Unknown不适用

Faculty of Dental Medicine, Boys, Cairo Al-Azhar University

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2015年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
45
试验地点
1
主要终点
plaque accumulation

研究概览

简要总结

Microbial and periodontal changes associated with conventional versus self ligating brackets.

The aim of this study will be to compare microbial and periodontal changes associated with conventional versus self ligating brackets.

详细描述

Microbial and periodontal changes associated with conventional versus self ligating brackets.

Protocol submitted in partial fulfillment for the requirements of Master Degree in Orthodontics

Accumulation of biofilm on the tooth surfaces is associated with increased levels of oral streptococcus mutans and lactobacilli, which have been proved to be responsible for the onset of enamel demineralization and periodontal disease.

It has been shown that fixed appliance provides large number of retentive areas for plaque accumulation and impedes oral hygiene.

Three methods are currently used to connect the arch wire to the brackets, which are : ligation with stainless steel ligatures , using elastomeric ligatures, and the self-ligating brackets. , Each of these method has it's advantages and disadvantages, concerning the biofilm retention and the level of microorganisms. , Orthodontic treatment with conventional brackets my presents some periodontal changes caused by difficulty in oral hygiene maintenance, greater accumulation and qualitative alteration of plaque. Thus, in order to control oral hygiene and plaque level during fixed appliance therapy, manufacturers introduced self-ligating brackets (SLBs) which have been claimed to provide better oral hygiene and less plaque accumulation, because of fewer retentive sites for microbial colonization; without the need for stainless steel and elastomeric ligature. Clinically, the side effects of fixed orthodontic treatment, such as the qualitative bacterial shift, are manifested as plaque associated gingivitis, an increase in pocket probing depth (PPD), and bleeding on probing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •All patients should satisfy the following criteria:
  • •Age ranged between 14-18 years.
  • •All permanent teeth erupted (excluding third molars).
  • •Angle Class I with normal facial proportion.
  • •Moderate crowding (from 4 to 6 mm) or irregularity index greater than
  • •All cases require treatment with fixed appliance with non extraction approach.
  • •Good oral and general health.
  • •No previous or current periodontal diseases.
  • •No systemic disease or medication that may interfere with orthodontic teeth movement.
  • •No history of trauma, bruxism or parafunction.
  • •No previous orthodontic treatment.

排除标准

  • •Abnormal anteroposterior relationship or steep mandibular plane.
  • •Crowding more than 6 mm.
  • •Poor oral hygiene or periodontal affection.
  • •Uncooperative patients.
  • •Smoker patients.
  • •Pregnant females.

研究组 & 干预措施

Group I:

Active Comparator

will be treated using conventional stainless steel orthodontic brackets ligated with stainless steel ligature. Oromco - USA.

.

干预措施: conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA) (Device)

Group II

Experimental

: will be treated using passive self-ligating stainless steel orthodontic brackets Oromco - USA.

干预措施: passive self-ligating stainless steel orthodontic brackets (Oromco - USA) (Device)

Group III:

Experimental

will be treated by active self-ligating stainless steel orthodontic brackets Oromco - USA .

干预措施: active self-ligating stainless steel orthodontic brackets (Oromco - USA) (Device)

结局指标

主要结局

plaque accumulation

时间窗: every month for 6 months after bonding.

plaque accumulation will be assess using Silness and Loe index

Gingival bleeding

时间窗: every month for 6 months after bonding.

Gingival bleeding will be evaluated by the presence or absence of bleeding on probing

Pocket depth

时间窗: every month for six months

Pocket depth measured by a Williams periodontal probe at baseline before treatment and at monthly interval for 6 months after bonding.

Composite measure of Microbial parameters

时间窗: every month for 6 months after bonding.

Plaque sample will be taken at base line and at monthly interval for six months after bonding Plaque sample will be send to laboratory for isolation of streptococcus mutans and lactobacilli. The isolated strains will be cultured and counted

次要结局

未报告次要终点

研究者

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

Esam Al-hendi

Head of Dental department in Jepleh Hospital

Al-Azhar University

研究点 (1)

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