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临床试验/NCT07185711
NCT07185711已完成不适用

Tooth Stability Assessment in Cemento-Osseous Dysplasia Using Resonance Frequency Analysis and Bite Force Sensor

Eskisehir Osmangazi University2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2025年1月2日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
2
主要终点
Implant Stability Quotient (ISQ) values by Resonance Frequency Analysis (RFA)

研究概览

简要总结

This study aims to evaluate the periodontal attachment and ankylosis status of teeth associated with cemento-osseous dysplasia (COD). Using resonance frequency analysis (RFA) and a bite force sensor, the stability of COD-associated teeth was measured and compared with contralateral healthy teeth. These non-invasive and objective methods are expected to reveal the impact of COD lesions on the surrounding dentoalveolar structures.

详细描述

Cemento-osseous dysplasias represent the most common group of benign fibro-osseous lesions, frequently detected in the mandible and often asymptomatic. Although they generally do not require treatment, the remodeling of bone and cementum-like tissues around the tooth roots has clinical significance in terms of periodontal attachment and ankylosis. The present study aims to investigate the ankylosis status of teeth associated with COD lesions at different stages by using objective measurement tools.

In each patient, COD-associated teeth and contralateral healthy teeth were evaluated. Measurements were performed using resonance frequency analysis (RFA) with the Osstell™ device and additionally by a bite force sensor to assess functional stability. For RFA, SmartPeg magnetic attachments were fixed to the occlusal surface with composite resin, and three measurements were obtained in both mesio-distal and bucco-lingual directions. Mean ISQ values were then recorded. After measurements, SmartPeg was carefully removed without leaving residues, and patient comfort was evaluated using a six-point numeric rating scale.

The obtained RFA and bite force values will be statistically analyzed to compare COD-associated teeth with healthy controls. Furthermore, the study seeks to determine differences in ankylosis tendency across various COD stages and their potential impact on periodontal ligament integrity. This approach may provide valuable insights for understanding the clinical course of COD and for planning surgical interventions in symptomatic cases

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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 diagnosed with cemento-osseous dysplasia (COD) based on panoramic radiographs
  • Presence of at least one COD-associated tooth suitable for measurement
  • Availability of a contralateral healthy tooth to serve as a control
  • Teeth with healthy periodontal supporting tissues
  • Patients aged ≥18 years
  • Patients who have provided written informed consent

排除标准

  • Presence of systemic diseases that could affect bone or periodontal structures (e.g., uncontrolled diabetes, osteoporosis, metabolic bone diseases)
  • History of radiotherapy or chemotherapy in the head and neck region
  • Teeth with extensive caries, mobility, or periodontal disease
  • Patients with a history of orthodontic treatment or trauma in the relevant region

结局指标

主要结局

Implant Stability Quotient (ISQ) values by Resonance Frequency Analysis (RFA)

时间窗: At baseline (single measurement per tooth)

ISQ values obtained from COD-associated teeth and contralateral healthy teeth using the Osstell™ device. Measurements recorded in mesio-distal and bucco-lingual directions and averaged.

次要结局

  • Maximum Bite Force(At baseline (single measurement per tooth))

研究者

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

Ömür Dereci

Prof.

Eskisehir Osmangazi University

研究点 (2)

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