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临床试验/NCT07414264
NCT07414264已完成不适用

Ultrasonographic Analysis of the Effects of Fixed Lingual Retainer Placed After Orthodontic Treatment on Periodontal Parameters

Selcuk University1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2024年10月24日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
1
主要终点
Change in Gingival Thickness Measured by Ultrasonography

研究概览

简要总结

This prospective clinical study aims to evaluate the effects of fixed lingual retainers placed after orthodontic treatment on periodontal soft and hard tissue parameters using ultrasonographic imaging. A total of 53 participants (636 anterior teeth) who had completed fixed orthodontic therapy were examined at baseline, 3 months, and 6 months after retainer placement. Ultrasonographic assessments were performed to measure gingival thickness, marginal bone level, and gingival level. Periodontal clinical parameters, including plaque index, gingival index, probing depth, bleeding on probing, and clinical attachment loss, were also recorded. The study seeks to determine whether fixed retainers induce measurable alterations in periodontal structures and to explore potential correlations between gingival phenotype and ultrasonographic findings.

详细描述

Orthodontic retention is a critical phase following active treatment, aiming to maintain the corrected tooth positions and ensure long-term stability. Fixed lingual retainers are widely used due to their minimal patient compliance requirements and aesthetic advantages. However, the long-term presence of fixed retainers may influence periodontal health by altering plaque accumulation patterns and modifying soft and hard tissue dynamics. The literature remains inconclusive regarding whether these appliances cause clinically significant periodontal changes.

This prospective observational clinical study was conducted to evaluate the ultrasonographic and clinical periodontal changes that occur following the placement of fixed lingual retainers in orthodontically treated individuals. Fifty-three participants (aged 16-24 years) who had completed fixed orthodontic treatment were enrolled. All participants received fixed stainless-steel lingual retainers bonded to the anterior teeth (canine-to-canine) in both maxillary and mandibular arches. Participants were divided into four subgroups according to post-treatment incisor inclination changes determined by cephalometric analysis: Maxillary Retroclination, Maxillary Proclination, Mandibular Retroclination, and Mandibular Proclination groups.

Ultrasonographic imaging was performed using a high-frequency intraoral probe with a custom-designed silicone stabilizing cap to ensure consistent contact with the gingival tissue. Measurements were taken perpendicular to the tooth surface at three time points: immediately after retainer placement (T0), three months (T1), and six months (T2). The following ultrasonographic parameters were recorded:

Gingival thickness (GT)

Marginal bone level (MBL)

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
16 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Patients who have completed comprehensive orthodontic treatment with fixed appliances.
  • Patients with a fixed mandibular or maxillary lingual retainer in place for at least 6 months.
  • Age between 18 and 40 years.
  • Good general health with no systemic conditions affecting periodontal tissues.
  • Non-smokers or light smokers (<5 cigarettes/day).
  • Presence of all anterior teeth without significant restorations or prosthetic crowns.

排除标准

  • History of periodontal surgery or advanced periodontitis prior to orthodontic treatment.
  • Systemic diseases or medications affecting periodontal health (e.g., diabetes, immunosuppressive therapy).
  • Pregnancy or lactation.
  • Poor oral hygiene or non-compliance with oral hygiene instructions.
  • Teeth with caries, large restorations, or endodontic treatment in the area of interest.
  • Patients with removable retainers or interrupted use of fixed retainers.

研究组 & 干预措施

1. Maxillary Retroclination Group

Participants with completed fixed orthodontic treatment presenting retroclined maxillary anterior teeth. This group represents patients whose upper incisors show a lingual inclination relative to the Sella-Nasion (SN) plane. Periodontal and ultrasound (USG) parameters are evaluated at baseline, 3 months, and 6 months following retention.

2. Maxillary Proclination Group

Participants with completed fixed orthodontic treatment showing proclined maxillary anterior teeth. The upper incisors present a labial inclination relative to the SN plane. Periodontal and ultrasound (USG) parameters are compared across time intervals during retention.

3. Mandibular Retroclination Group

Participants with completed fixed orthodontic treatment and retroclined mandibular anterior teeth. The lower incisors exhibit lingual inclination relative to the mandibular plane. Periodontal and ultrasound (USG) parameters are longitudinally monitored during retention.

Mandibular Proclination Group

Participants with completed fixed orthodontic treatment presenting proclined mandibular anterior teeth. The lower incisors display labial inclination relative to the mandibular plane. Periodontal and ultrasound (USG) measurements are performed at baseline, 3-month, and 6-month follow-ups.

结局指标

主要结局

Change in Gingival Thickness Measured by Ultrasonography

时间窗: 6 months

Gingival thickness will be measured at baseline (T0), 3 months (T1), and 6 months (T2) after placement of fixed lingual retainers using high-frequency intraoral ultrasonography. Measurements will be performed at the mid-facial aspect of anterior teeth, perpendicular to the long axis of the tooth, through a customized silicone probe cap to ensure consistent contact and accuracy. The primary outcome is the mean change in gingival thickness (in millimeters) between baseline and 6-month evaluations, reflecting potential soft tissue alterations associated with fixed lingual retainers.

次要结局

未报告次要终点

研究者

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

metehan özdemir

Research Assistant

Selcuk University

研究点 (1)

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