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临床试验/NCT04950829
NCT04950829已完成不适用

Evaluation of Leveling and Alignment Time and the Periodontal Status in Patients With Severe Upper Crowding Treated by Flapless Corticotomy-assisted Self-ligating Brackets in Comparison With Conventional or Self-Ligating Brackets Alone

Damascus University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2018年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
Duration of teeth alignment

研究概览

简要总结

Patients who have severe crowding on the upper jaw that requires two first premolars extraction will be enrolled in this trial. The different types of brackets, such as self-ligating brackets and conventional brackets, and the various acceleration methods, such as corticotomy, have different effects on the orthodontic treatment time and the periodontal tissues. So, this study will assess and compare the overall leveling and aligning time and the changes in periodontal indices between patients with severe crowding, treating with self-ligating brackets associated with flapless corticotomy versus conventional brackets alone versus self-ligating brackets alone.

There are three groups:

The first group (control group): the patients in this group will be treated using conventional brackets alone.

The second group (Experimental group): the patients in this group will be treated using self-ligating brackets alone.

The third group (Experimental group): the patients in this group will be treated using self-ligating brackets associated with flapless corticotomy.

详细描述

The prolonged duration of the treatment period can cause many problems such as caries and periodontal diseases. The oral environment is considered a suitable environment for many germs and microorganisms to grow. Any increase in the percentage of these germs predisposes to the occurrence of dental and periodontal problems.

Several studies have used various procedures and many types of brackets to accelerate dental movement in order to reduce treatment time.

Orthodontic treatment using different devices usually contributes to change the nature of the oral environment and its contents of microorganisms Many bracket systems have been used, such as the conventional brackets and self-ligating brackets. The use of self-ligating brackets has increased significantly in recent years. The absence of wired or elastic elements may cause less accumulation of plaque.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
17 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Sever crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires extraction of two upper premolars.
  • The Little's Index of Irregularity is more than 7 mm.
  • Good oral health (plaque Index is less or equal to 1).
  • Class I or class II (ANB ≤ 5) or class III (ANB ≥ 0).
  • Overbite is between 0-4 mm.
  • No skeletal constriction on the upper jaw.
  • No congenitally missing or extracted teeth (except for the third molars).

排除标准

  • Any systemic diseases affect teeth movement.
  • Any congenital syndromes or cleft lip and palate.
  • Bad oral health.
  • The patient is not committed to periodic follow-up times.

结局指标

主要结局

Duration of teeth alignment

时间窗: This will be measured immediately at the end of the alignment stage; this is expected to be within 180 to 200 days

The number of days required to finish the alignment stage of upper teeth will be calculated from the beginning of treatment till the end of the alignment stage (i.e. teeth alignment is achieved)

次要结局

  • The change in the plaque index.(T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months)
  • The change in papillary bleeding index.(T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months)
  • The change in the gingival index(T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months)
  • The change in the probing depth(T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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