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Predictors of Periodontal Outcomes Post-sanative Therapy

NCT ID: NCT04639661

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-25

Study Completion Date

2021-10-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Periodontal Diseases Periodontal Pocket

Keywords

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Periodontal therapy Flavonoids Tea Dietary intake Supplements Physical activity Exercise Sedentary time Estrogen Lifetime estrogen exposure Periodontal maintenance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery

OTHER

Sponsor Role collaborator

Brock University

OTHER

Sponsor Role lead

Responsible Party

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Wendy E. Ward, Ph.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wendy E Ward, PhD

Role: PRINCIPAL_INVESTIGATOR

Brock University

Locations

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Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery

Fonthill, Ontario, Canada

Site Status

Brock University

St. Catharines, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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20-070

Identifier Type: -

Identifier Source: org_study_id