Predictors of Periodontal Outcomes Post-sanative Therapy

Overview

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.

Full Title of Study: “Predictors of Periodontal Outcomes in Patients 5 to 10 Years Post-sanative Therapy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 2021

Detailed Description

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.

Clinical Trial Outcome Measures

Primary Measures

  • Probing depth
    • Time Frame: At maintenance appointment (present day)
    • This is a routine clinical measure of periodontal health (measured in mm)
  • Probing depth
    • Time Frame: Pre-sanative therapy
    • This is a routine clinical measure of periodontal health (measured in mm)
  • Probing depth
    • Time Frame: 8-12 weeks post-sanative therapy
    • This is a routine clinical measure of periodontal health (measured in mm)
  • Bleeding on probing
    • Time Frame: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
    • This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth
  • Bleeding on probing
    • Time Frame: Pre-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
  • Bleeding on probing
    • Time Frame: 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

Secondary Measures

  • Tooth Loss
    • Time Frame: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
    • Will be measured as the number of teeth lost due to periodontal disease
  • Tooth Loss
    • Time Frame: Pre-sanative therapy
    • Will be measured as the number of teeth lost due to periodontal disease
  • Tooth Loss
    • Time Frame: 8-12 weeks post-sanative therapy
    • Will be measured as the number of teeth lost due to periodontal disease
  • O’Leary Index of Plaque Control
    • Time Frame: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
    • The patient’s plaque index= the number of plaque-containing surfaces divided by the total number of available surfaces. The minimum plaque index would be 0% which represents no tooth surfaces that contain plaque/ The maximum plaque index would be 100%, which represents all surfaces of the patient’s teeth containing plaque.
  • O’Leary Index of Plaque Control
    • Time Frame: Pre-sanative therapy
    • The patient’s plaque index= the number of plaque-containing surfaces divided by the total number of available surfaces. The minimum plaque index would be 0% which represents no tooth surfaces that contain plaque/ The maximum plaque index would be 100%, which represents all surfaces of the patient’s teeth containing plaque.
  • O’Leary Index of Plaque Control
    • Time Frame: 8-12 weeks post-sanative therapy
    • The patient’s plaque index= the number of plaque-containing surfaces divided by the total number of available surfaces. The minimum plaque index would be 0% which represents no tooth surfaces that contain plaque/ The maximum plaque index would be 100%, which represents all surfaces of the patient’s teeth containing plaque.

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:
  • 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)
  • Gender Eligibility: All

    Minimum Age: 19 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Brock University
    • Collaborator
      • Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
    • Provider of Information About this Clinical Study
      • Principal Investigator: Wendy E. Ward, Ph.D., Professor – Brock University
    • Overall Official(s)
      • Wendy E Ward, PhD, Principal Investigator, Brock University

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