Clinical trial NCT04639661: Predictors of Periodontal Outcomes Post-sanative Therapy
Official title: Predictors of Periodontal Outcomes in Patients 5 to 10 Years Post-sanative Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Periodontal Diseases
Periodontal Pocket
Keywords: Periodontal therapy
Flavonoids
Tea
Dietary intake
Supplements
Physical activity
Exercise
Sedentary time
Estrogen
Lifetime estrogen exposure
Periodontal maintenance
Lead sponsor: Brock University
Sponsor class: OTHER
Collaborators: name: Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
First posted: 2020-11-20
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who underwent sanative therapy to manage periodontal disease at this clinic 5 to 10 years before present-day appointment. Only patients who have maintained regular maintenance appointments after receiving sanative therapy will be eligible.

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Probing depth
timeFrame: At maintenance appointment (present day)
measure: Probing depth
timeFrame: Pre-sanative therapy
measure: Probing depth
timeFrame: 8-12 weeks post-sanative therapy
measure: Bleeding on probing
timeFrame: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
measure: Bleeding on probing
timeFrame: Pre-sanative therapy
measure: Bleeding on probing
timeFrame: 8-12 weeks post-sanative therapy
Secondary outcomes:
measure: Tooth Loss
timeFrame: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
measure: Tooth Loss
timeFrame: Pre-sanative therapy
measure: Tooth Loss
timeFrame: 8-12 weeks post-sanative therapy
measure: O'Leary Index of Plaque Control
timeFrame: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
measure: O'Leary Index of Plaque Control
timeFrame: Pre-sanative therapy
measure: O'Leary Index of Plaque Control
timeFrame: 8-12 weeks post-sanative therapy
Other outcomes:
measure: Body Mass Index (BMI)
timeFrame: Patients will complete this in an online questionnaire at present day (baseline).
measure: Godin Leisure Time Exercise Questionnaire
timeFrame: Patients will complete this in an online questionnaire at present day (baseline).
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Patients will complete this online questionnaire at present day (baseline).
measure: Flavonoid and protein intake
timeFrame: Patients will report their dietary intake at present day (baseline) for the past 24 hours. This will be done three times for three separate dates.
measure: Lifetime estrogen exposure (LEE)
timeFrame: Patients will complete this online questionnaire at present day (baseline).
measure: Dietary supplement and tea intake
timeFrame: Patients will complete this questionnaire online prior to their maintenance appointment
measure: COVID-19 Interview questions
timeFrame: Patients will complete these interview questions during their one-on-one virtual meeting with a member of the research team at present day (baseline).
Locations:
city: Fonthill
country: Canada
facility: Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
state: Ontario
city: St. Catharines
country: Canada
facility: Brock University
state: Ontario
Study officials:
affiliation: Brock University
name: Wendy E Ward, PhD
role: PRINCIPAL_INVESTIGATOR
References: