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临床试验/NCT07445555
NCT07445555招募中不适用

Gingival Recessions in Orthodontically Treated and Untreated Adult Patients: a Prospective Study

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Occlusion

研究概览

简要总结

To identify the predisposing parameters for gingival recessions in adult patients seeking orthodontic treatment. The ultimate aim is to provide a clinical guideline to estimate the risk of developing post-orthodontic gingival recessions.

详细描述

The etiology of gingival recessions is yet to be fully understood and is very likely multifactorial, with the involved parameters not necessarily acting simultaneously or in equal extent. The most common etiologic factor would be dental plaque accumulation followed by traumatic tooth brushing, areas with thin, minimal or no keratinized tissue, smoking, malocclusion, dental trauma and high frenal attachment. The labial aspect of the mandibular incisors and maxillary molars is the most often affected by gingival recessions. These contributing factors identified in literature could be grouped in six main categories: age-related, population-related, site-related, mechanical factors, periodontal condition and iatrogenic factors, like orthodontic treatment.

Although quantifying the influence of each factor is very difficult, the association between gingival recessions and orthodontic treatment as an iatrogenic factor has been repeatedly suggested. Given the increasing amount of adult patients seeking orthodontic treatment, the aim of this study is to identify the predisposing parameters for gingival recessions in adult patients, seeking orthodontic treatment. The ultimate aim is to provide a clinical guideline to estimate the risk of developing post-orthodontic gingival recessions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients with or without previous history of orthodontic treatment with and without gingival recessions
  • ≥ 18 years old
  • American Society of Anesthesiologists Classification I or II

排除标准

  • Patients with history of periodontal disease
  • taking the following medication: anticoagulants, phenytoin, cyclosporine, nifedipine or calcium channel blockers
  • Patients with prior history of radio or chemotherapy
  • Pregnant or breastfeeding patients
  • Patients with agenesis of one or more lower incisors
  • Exclusion Criteria:
  • Patients with history of periodontal disease Patients taking the following medication: anticoagulants, phenytoin, cyclosporine, nifedipine or calcium channel blockers Patients with prior history of radio or chemotherapy Pregnant or breastfeeding patients Patients with agenesis of one or more lower incisors

研究组 & 干预措施

Orthodontically untreated patient - without recession

Orthodontically untreated patient - without recession

Orthodontically treated patient - with recession

Orthodontically treated patient - with recession

干预措施: Registration of parameters (Other)

Orthodontically treated patient - without recession

Orthodontically treated patient - without recession

Orthodontically untreated patient - with recession

Orthodontically untreated patient - with recession

干预措施: Registration of parameters (Other)

结局指标

主要结局

Occlusion

时间窗: 6 months

Assessed as: N.A, 1 DO, 3/4 DO, 1/2 DO,1/4 DO, NO, 1/4 MO, 1/2 MO, 3/4 MO, 1 MO

Occlusal contact points

时间窗: 6 months

Measured in mm ( 0.0 to 3.0)

Full Mouth Plaque Score (FMPS)

时间窗: 6 months

In % of total sites (0 to 100)

Gingival parameters

时间窗: 6 months

Presence of Recessions (Location and extension): in mm (0 to 9)

Periodontal phenotype:

时间窗: 6 months

measured from 0.01 to 9.00 (Biometric Ultrasound Scanner)

Full Mouth Bleeding scores (FMBS)

时间窗: 6 months

In % of total sites (0 to 100)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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