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临床试验/NCT04639661
NCT04639661终止不适用

Predictors of Periodontal Outcomes in Patients 5 to 10 Years Post-sanative Therapy

Brock University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年11月25日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
2
主要终点
Bleeding on probing

研究概览

简要总结

Periodontal disease is a chronic inflammatory disease of the tissues surrounding the teeth and is one of the leading causes of tooth loss. Sanative therapy (ST) is a non-surgical procedure that allows for removal of bacteria from the deep pockets that form around teeth and is the frontline treatment for periodontal disease. Post-ST, patients require ongoing maintenance appointments to maintain their oral health, though whether risk factors for periodontal disease remain a predictor of periodontal health post-ST has not been comprehensively investigated. Risk factors to be examined include physical activity, exercise, sedentary time, flavonoid intake, protein intake, BMI, sex, age, smoking status, and number of sites with periodontal probing depth (PPD) ≥ 4mm at baseline.

详细描述

Periodontal disease is a main cause of tooth loss. Patients with periodontal disease may receive sanative therapy (ST), a deep cleaning of the teeth that helps prevent the progression of periodontal disease. Post-ST, maintenance appointments are an important part of the strategy used to help these patients prevent the progression of periodontal disease and maintain their periodontal health. Given that numerous chronic diseases, obesity, low levels of physical activity, being a smoker, poor diet, and older age are all risk factors for periodontal disease, these factors may also be predictive of worse periodontal health 5 to 10 years post-ST. Many modifiable periodontal risk factors such a physical activity, exercise, and obesity have not been studied in relation to periodontal outcomes post-ST, and other factors such as diet, sex and age have not been comprehensively studied. The primary objective of this study is to determine, at 5 to 10 years post-ST, if physical activity, exercise, sedentary time, flavonoid intake, protein intake, BMI, sex, age, smoking status, and number of sites with periodontal probing depth (PPD) ≥ 4 mm at baseline are significant predictors of periodontal health. A secondary objective is to determine if lifetime estrogen exposure impacts periodontal health in women. Periodontal health will be measured using probing depth, tooth loss, bleeding on probing and plaque index. Established questionnaires will be used to assess dietary intake, physical activity and sedentary behaviour. Within the study the investigators will also assess if and how a patient's periodontal health has been impacted by clinic closures and rescheduling of maintenance appointments that were mandated by regulatory organizations as a result of the COVID-19 pandemic. The investigators will also ask questions about changes in diet, physical activity and oral hygiene during COVID-19.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have undergone sanative therapy (ST) in the past 5 to 10 years
  • Age > 19 years
  • Willingness and ability to provide informed consent. Participants must be able and willing to complete online questionnaires from home and give permission for access to their periodontal records from the time of their sanative therapy to present day

排除标准

  • Individuals with physical or mental limitations that inhibit them from conducting their own personal oral hygiene (oral hygiene is a key component in maintaining periodontal health)
  • Women who are currently pregnant or breastfeeding (hormonal changes during pregnancy are known to cause gingival inflammation)

结局指标

主要结局

Bleeding on probing

时间窗: 8-12 weeks post-sanative therapy

This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth

Probing depth

时间窗: 8-12 weeks post-sanative therapy

This is a routine clinical measure of periodontal health (measured in mm)

次要结局

  • Tooth Loss(8-12 weeks post-sanative therapy)
  • O'Leary Index of Plaque Control(8-12 weeks post-sanative therapy)

研究者

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

Wendy E. Ward, Ph.D.

Professor

Brock University

研究点 (2)

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