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临床试验/NCT07318623
NCT07318623尚未招募不适用

Comparative Evaluation of Treatment Outcomes Between Damon Ultima and Pitts 21 Pro Bracket Systems; A Randomized Clinical Trial

University of Baghdad1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年5月31日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
To compare the total treatment time between Damon Ultima and Pitts 21 Pro bracket systems.

研究概览

简要总结

Title Comparative Evaluation of Treatment Outcomes between Damon Ultima and Pitts 21 Pro Bracket Systems; A Randomized Clinical Trial Abstract Background: The primary advantages of self-ligation brackets include faster archwire removal and ligation, reduced or eliminated need for chairside assistance, secure archwire engagement, and lower bracket-archwire friction, which collectively contribute to a substantial reduction in resistance to sliding and are theorized to enhance the efficiency of initial tooth alignment. This randomized controlled trial (RCT) will be conducted to assess differences in treatment outcomes with these two different self-ligation bracket systems.

Subjects/Materials and Methods: This randomized clinical trial included 40 participants with full permanent dentition (excluding third molars) exhibiting Angle Class I malocclusion with moderate crowding. Patients who were scheduled to undergo orthodontic treatment were allocated into two groups: Damon Ultima and Pitts 21 Pro. The total treatment duration will be measured in months from the bonding day to the completion of treatment, in addition to the number of visits.

Pre-treatment, post-alignment, and post-treatment records were obtained, including intraoral scans (IOS) for assessing alignment efficiency and arch parameters. Periapical radiographs of the upper and lower incisors were taken before and after treatment to measure the amount of root resorption. Treatment outcomes were evaluated using the American Board of Orthodontics (ABO) grading system. Additionally, pain perception and patient treatment perception were assessed.

详细描述

Comparative Evaluation of Treatment Outcomes between Damon Ultima and Pitts 21 Pro Bracket Systems:

A Randomized Clinical Trial

A Protocol Submitted to the Council of the College of Dentistry, University of Baghdad in Partial Fulfillment of Requirements for the Degree of Doctor of Philosophy in Orthodontics By Hussain Jabar Kadhem B.D.S., M.Sc. (Orthodontics)

Supervised by:

Professor Dr. Mohammed Nahidh B.D.S, M.Sc., Ph.D. (Orthodontics)

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of full permanent dentition except the third molars.
  • Class I with moderate crowding requiring fixed appliance therapy and don't need extraction.
  • Good dental hygiene and periodontal health.
  • Good general health; no systemic conditions affecting bone metabolism or pain perception.
  • Normal crown size and shape.
  • No prior orthodontic treatment.
  • Patient has a normal level of vitamin D3 in testing (Vit D3 serum level should be >30).

排除标准

  • Severe skeletal discrepancies requiring orthognathic surgery, craniofacial anomalies). Patients with active periodontal disease or medically compromised patients.

研究组 & 干预措施

Damon ultima bracket group

Active Comparator

Treatment outcome of Damon ultima bracket

干预措施: Treatment outcome of Damon ultima (Device)

Pitt21 pro bracket group

Active Comparator

Treatment outcome of Pitt21 pro bracket

干预措施: Treatment outcome of pitt21 pro (Device)

结局指标

主要结局

To compare the total treatment time between Damon Ultima and Pitts 21 Pro bracket systems.

时间窗: 24 month

To compare the total treatment time between Damon Ultima and Pitts 21 Pro bracket systems from the day of bracket bonding to the day of debonding.

次要结局

  • Alignment efficiency(up to 6 month)
  • 2. Comparison of pain perception(through study completion, an average of 2 year)
  • the amount of orthodontically induced inflammatory root resorption (OIIRR)(through study completion, an average of 2 year)
  • Evaluating the dental arch dimensions(through study completion, an average of 2 year)
  • bracket debonding events(through study completion, an average of 2 year)
  • 6. Evaluating the quality of finished case.(through study completion, an average of 2 year)

研究者

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

Hussain Jabar Kadhem

Assistant teacher

University of Baghdad

研究点 (1)

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