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临床试验/NCT04769622
NCT04769622Unknown不适用

Influence of Environmental Factors on the Efficacy of Non-surgical Periodontal Treatment. A Pre-post Quasi-experimental Study

University of Siena1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2021年2月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
125
试验地点
1
主要终点
Treat-to-target after treatment (yes/no)

研究概览

简要总结

Periodontitis is a biofilm-mediated chronic inflammatory disease which causes the destruction of the supporting tissues of the tooth. Risk factors for periodontitis include familiarity for periodontal diseases, diabetes, cardiovascular diseases, metabolic syndrome, obesity and stress. Some studies demonstrated how these risk factors negatively influence the patients' response to non-surgical periodontal treatment. The success of non-surgical periodontal therapy is defined through the treat-to-target concept (i.e. a maximum of 4 sites with Probing Pocket Depth >5mm and presence of Bleeding on Probing); therefore, periodontal treatment is successful whenever this threshold is reached. Moreover, given the available data regarding the association between more severe forms of periodontitis and a lower frequency of physical activity, a worse sleep quality and more perceived stress, it is reasonable to hypothesize that these factors could influence the patients' response to non-surgical periodontal treatment. With regards to diet, despite many studies appraised the anti-inflammatory effect of the mediterranean diet, no study has ever related adherence to Mediterranean Diet to oral health status. The novelty that the present study would introduce is the evaluation of how environmental factors (i.e. diet, physical exercise, perceived stress) influence patients' response to non-surgical periodontal therapy.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18 and 70 years old;
  • presence of untreated periodontitis (Papapanou at al. 2018);
  • ability and willingness to give informed consent.

排除标准

  • pregnancy or lactation;
  • patients who underwent non-surgical periodontal therapy in the last 6 months;
  • patients taking immunosuppressive drugs;
  • inability or unwillingness to give informed consent.

结局指标

主要结局

Treat-to-target after treatment (yes/no)

时间窗: outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment)

Binary outcome defining the success of non-surgical periodontal treatment. The treat-to-target is reached whenever patients at reevaluation have a maximum of 4 sites with Probing Pocket Depth (PPD) \>5mm and presence of Bleeding on Probing (BoP)

次要结局

  • Influence of Sleep Quality on the success of non-surgical periodontal treatment (treat-to-target)(outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment))
  • Influence of Physical Activity on the success of non-surgical periodontal treatment (treat-to-target)(outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment))
  • Influence of Perceived Stress on the success of non-surgical periodontal treatment (treat-to-target)(outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment))
  • Influence of adherence to Mediterranean diet on the success of non-surgical periodontal treatment (treat-to-target)(outcome measured at reevaluation (3 months after the completion of non-surgical periodontal treatment))

研究者

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

Nicola Discepoli

Researcher

University of Siena

研究点 (1)

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