跳至主要内容
临床试验/NCT07706400
NCT07706400尚未招募不适用

Treatment of Mandibular Overjet in Children With Maxillary Retrognathism

Malmö University3 个研究点 分布在 2 个国家目标入组 180 人开始时间: 2026年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
180
试验地点
3
主要终点
Change in sagittal maxillary skeletal position

研究概览

简要总结

The project involves a 10-year prospective longitudinal cohort multicentre study where orthodontic treatment and treatment effect is followed in children with Cl III due to maxillary retrognathia who undergo standardized orthodontic interceptive treatment. Standard clinical procedures are followed as usual at each clinic where standard diagnostic and follow up materials are taken before treatment, after treatment and follow ups after 5 and 10 years. The project will not introduce or test new treatment modalities, additional procedures or behavioural regulation in relation to normal clinical practice or new medical devices. The standard diagnostic and follow up materials in each clinic include examination of the dentition, occlusion, craniofacial morphology, and orofacial function. The analyses are based on the following standardized registration methods which are carried out on all the patients. Information from the patient record is included.

The patient related outcome measurements will be assessed by five different questionnaires. No biological material is collected for the project.

详细描述

The aims of this project on treatment of young patients with Cl III due to maxillary retrognathia are to: 1) compare timing and treatment approaches for orthodontic treatment between national clinics and between two Scandinavian countries, Sweden and Denmark; 2) compare the treatment effect immediately after treatment between various orthodontic treatment approaches; 3) compare the treatment effect and side effects as well as patient perspectives in the short and long term after treatment between different orthodontic treatment approaches; 4) analyse the significance of timing, treatment approaches, and craniofacial morphology for short- and long-term predictions, treatment effects and side effects in the orthodontic treatment.

The project is based upon a comparison of well-established treatment approaches for Cl III due to maxillary retrognathia. It will not introduce or test new treatment modalities, additional procedures or behavioural regulation in relation to normal clinical practice or the use of medical devices.

Relevance of the project The project may contribute to identifying which treatment approaches and timing are most effective for orthodontic treatment of Cl III due to maxillary retrognathia. The results are therefore important for the choice of treatment approach and prognosis for the individual patient, and socio-economically important as treatment of Cl III in a better way may be tailored the individual patient whereby treatment effect may be optimised.

Method The project involves a 10-year prospective longitudinal cohort multicentre study where orthodontic treatment and treatment effect is followed in children with Cl III due to maxillary retrognathia who undergo standardized orthodontic interceptive treatment. Standard clinical procedures are followed as usual at each clinic where standard diagnostic and follow up materials are taken before treatment, after treatment and follow ups after 5 and 10 years. The project will not introduce or test new treatment modalities, additional procedures or behavioural regulation in relation to normal clinical practice or new medical devices. The standard diagnostic and follow up materials in each clinic include examination of the dentition, occlusion, craniofacial morphology, and orofacial function. The analyses are based on the following standardized registration methods which are carried out on all the patients. Information from the patient record is included.

General registrations:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Mandibular overjet due to maxillary retrognathia (Overjet </= 0 mm)
  • Age 9-12 years
  • Informed consent from parents/guardians

排除标准

  • Mandibular overjet mainly due to mandibular prognathism
  • Known general and/or craniofacial syndromes/diseases
  • Adenoid vegetations, hypertrophic tonsils and significantly reduced air passage through nose (mouth breathing), which must be primarily treated
  • Functional disorders in muscles and jaw joints, which must be primarily treated

结局指标

主要结局

Change in sagittal maxillary skeletal position

时间窗: Baseline (mixed dentition) to young adulthood, up to 10 years.

Sagittal maxillary skeletal position will be assessed using standardized lateral cephalometric radiographs. Cephalometric measurements reflecting anterior (mesial) displacement of the maxilla will be obtained at baseline during the mixed dentition stage and at follow-up in young adulthood. Changes in maxillary position will be compared among participants receiving different interceptive orthodontic treatments and untreated controls.

次要结局

  • Oral health-related quality of life and Self-esteem(Baseline through young adulthood (up to 10 years) with start July 31 2026 to July 2028 until the end of the study.)

研究者

发起方
Malmö University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mikael Sonesson

Associate Professor

Malmö University

研究点 (3)

Loading locations...

相似试验