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临床试验/NCT06426069
NCT06426069尚未招募不适用

Assessment of Masticatory Performance in Various Stages of Periodontitis

Postgraduate Institute of Dental Sciences Rohtak1 个研究点 分布在 1 个国家目标入组 555 人开始时间: 2024年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
555
试验地点
1
主要终点
Objective masticatory performance

研究概览

简要总结

The loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health.This clinical trial aims to assess the status of masticatory performance among patients with stage I, stage II, stage III and stage IV periodontitis, along with those with healthy periodontium.

详细描述

Periodontal disease manifestations include gingival bleeding, halitosis, tooth mobility and loss of teeth in advanced cases. The loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health. Loss of periodontium leads to reduced ability of tooth to withstand masticatory loads. Thus, biting abilities of subjects with healthy periodontium are significantly greater than those of chronic periodontitis patients. Even though the new periodontitis classification includes masticatory dysfunction in stage 4, but clinical periodontal parameters do start influencing objective masticatory efficiency in early stages. Since the masticatory function is an important point for the classification of periodontitis, standardized procedures with corresponding reference values are needed to consider these parameters in the assessment of periodontitis and to be able to make specific therapy recommendations.

This clinical trial aims to assess the changes in masticatory performance among periodontitis patients of all stages and healthy individuals using test methods easily applicable in daily practice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with age group 30-50 years diagnosed with generalized periodontitis
  • Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars.

排除标准

  • Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases)
  • Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis)
  • Grade C periodontitis (evaluated indirectly by radiographic bone loss/age criteria)
  • Smoking or substance abuse
  • Pregnant and lactating women

结局指标

主要结局

Objective masticatory performance

时间窗: Baseline

Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum, through optoelectronic analysis using a software.

次要结局

  • Subjective masticatory performance(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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