Ulta-High Frequency Ultrasound Assessment of Normal Versus Gingivitis Affected Gingival Tissues
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Echogenicity
研究概览
简要总结
Gingival inflammation triggered by the accumulation of bacterial is the primary risk factor for the development of periodontitis. Clinically, localized signs of inflammation limited to the gingiva, presence of significant bacterial plaque load, and stable attachment levels on the periodontium can be observed in course of gingivitis. The aim of the present study is to compare clinical aspects of gingival tissue in healthy patients versus patients with gingivitis to assess the ultrastructural variations present in course of inflammation.
Patients with gingivitis and healthy controls will be enrolled. All patients will undergo ultra-high frequency ultrasonographic scans (70 MHz) of gingival tissue on three areas per dental arch (anterior, middle right, middle left). Gingival thickness, echogenicity, and vascularization assessed through resisitive index will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •males or females of age > 18 years
- •presence of at least 20 teeth
- •full-mouth plaque score (FMPS) >50%
- •FMBS >30%
- •ability and willingness to give informed consent
排除标准
- •pregnancy or breastfeeding
- •pharmacological treatment with antinflammatory drugs, statins, or either local or systemic antibiotics (within the previous 30 days)
- •smoking habit
- •dental or periodontal condition requiring immediate treatment
- •refusal to be enrolled in the study
结局指标
主要结局
Echogenicity
时间窗: measured once at enrollemnt
Variations in echogenicity assessed through grey levels distribution between healthy patients versus gingivitis
次要结局
- Vascular parameters(measured once at enrollemnt)
- DMFT(measured once at enrollement)
- PPD(measured once at enrollement)
- FMBS(measured once at enrollement)
- FMPS(measured once at enrollement)
研究者
Rossana Izzetti
Principal Investigator, Researcher at the Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine of the University of Pisa
University of Pisa