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临床试验/NCT07185087
NCT07185087进行中(未招募)不适用

Evaluation of Treatment Progress and the Compliance of Patients Treated With DAMON Braces Versus Patients Treated With MBT Braces During Early Stage of Treatment: A Randomized Clinical Trial

University of Baghdad1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
34
试验地点
1
主要终点
Degree of orthodontic treatment improvement assessed using ABO Discrepancy Index

研究概览

简要总结

Comparison between two bracket prescription systems, MBT and DAMON Ultima brackets and evaluate whether the changes incorporated in DAMON Ultima brackets can drive earlier improvement on teeth position, clinically visual progression of treatment, during initial stage of treatment. Another aim of this study is the effect of chosen bracket system on patient compliance.

详细描述

A single-operator, single-center randomized controlled trial (RCT) with a 1:1 allocation ratio will be conducted for patients seeking orthodontic treatment with fixed appliances. The study will take place at the Postgraduate Orthodontic Clinic, College of Dentistry, University of Baghdad, Baghdad, Iraq. Patients who meet the eligibility criteria will be randomly assigned to one of two bracket-type groups. To eliminate inter-operator variability, all patients will be treated by a single operator.

A standardized protocol will be followed. Each patient will undergo extraoral and intraoral photography, intraoral scanning with Medit i700 (Medit Corp., Seoul, South Korea), and radiographic evaluation (CBCT and lateral cephalogram). On bonding day, gingival index and plaque index will be assessed. All teeth will then be isolated and cleaned with a mixture of water and pumice using a rubber-polishing cup on a low-speed handpiece. The teeth will be rinsed and dried with an oil-free air syringe, and etched using the conventional acid-etching technique (37% orthophosphoric acid applied for 30 seconds). The surfaces will be thoroughly rinsed with water for 10 seconds to ensure complete removal of the etchant, in accordance with the manufacturer's instructions. The enamel will then be gently dried with air until a frosty-white appearance is observed.

A uniform coat of universal bonding primer (Ortho Solo, Ormco Corp., Glendora, California, USA) will be applied to the etched surfaces using a nylon bond brush. Each tooth will receive a gentle air blow for 2 seconds with the air stream directed perpendicular to the enamel surface. After etching and priming, a thin layer of adhesive (Green Glow, Ormco Corp., Glendora, California, USA) will be applied to the mesh base of each bracket, which will be positioned on the buccal surface of the tooth using a bracket holder. The bracket height will be determined according to the manufacturer's instructions. Any excess adhesive will be carefully removed from around the base of the bracket with a dental probe prior to curing, without disturbing the seated bracket. The adhesive will then be light-cured for 20 seconds.

In the intervention group, Damon Ultima brackets (Ormco Corp., Glendora, California, USA) will be bonded from the second molar to the second molar in each arch. In the comparison group, MBT Mini Diamond brackets (Ormco Corp., Glendora, California, USA) will be bonded from the second molar to the second molar in each arch. Damon Ultima archwires (Ormco Corp., Glendora, California, USA) will be used for both groups in the following sequence: 0.014-inch CuNiTi, 0.018-inch CuNiTi, and 0.014 × 0.0275-inch CuNiTi.

All patients will receive an oral hygiene kit, a brochure on dietary recommendations, and a printed questionnaire to assess pain during treatment (developed for the study). Patients will be reviewed every 8 weeks, during which gingival index, plaque index, photographs, intraoral scans, and questionnaires will be collected. Patients will also be instructed to contact the operator immediately and attend as soon as possible in the event of bracket bond failure. The treatment will be followed up for 6 months.

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
16 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Both gender
  • •Age range between 16-40years of age.
  • •ANB angle not <1° and not >5°.
  • •Mild to moderate crowding, spacing and rotation.
  • •Requiring non-extraction treatment.
  • •The patient agreed to be part of this study.

排除标准

  • •A history of previous orthodontic treatment with fixed appliance.
  • •Permanent teeth extraction except third molar.
  • •Congenital anomaly.
  • •Cleft lip and palate patients.
  • •Patients with ectopic canine or other teeth.
  • •Patients with severe crowding (<6mm).

研究组 & 干预措施

Damon

Experimental

Damon Ultima Self-ligating Brackets

干预措施: passive self-ligating, Damon Ultima brackets (Device)

MBT

Active Comparator

MBT Mini Diamond Conventional brackets

干预措施: Conventional ligation, MBT brackets (Device)

结局指标

主要结局

Degree of orthodontic treatment improvement assessed using ABO Discrepancy Index

时间窗: 6 months

Description: Evaluation of improvement in tooth rotation/alignment, overjet, overbite, occlusal relationship, interproximal contact, and cephalometric parameters. Time Frame: At multiple time intervals during the alignment stage (up to 6 months). Method: American Board of Orthodontics Discrepancy Index scoring system. Unit of Measure: DI points

Reduction in Malocclusion Assessed by Peer Assessment Rating (PAR) Index

时间窗: 6 months

Description: Measurement of the rate of dental alignment during treatment. Time Frame: At multiple time intervals during the alignment stage (up to 6 months). Method: Standardized PAR scoring applied to digital dental casts. Unit of Measure: PAR score

Improvement in Malocclusion Severity Assessed by Index of Orthodontic Treatment Need (IOTN-DHC)

时间窗: 6 months

Description: Comparison of treatment need improvement before treatment and after completion of the alignment stage. Time Frame: Baseline and after alignment stage (approximately 6 months). Method: IOTN-DHC assessment. Unit of Measure: IOTN grade.

次要结局

  • Changes in Oral Hygiene and Gingival Health During Treatment(6 months)
  • Incidence of Bracket Bonding Failures During Treatment(6 months)
  • Patient Pain Perception During Orthodontic Treatment(6 months)
  • Patient-Reported Smile Attractiveness and Confidence(6 months)

研究者

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

Jehan Fadhil IBrahim

Principal Investigator, Orthodontics Department, University of Baghdad

University of Baghdad

研究点 (1)

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