Periodontal Diseases Clinical Trial
Official title:
Predictors of Periodontal Outcomes in Patients 5 to 10 Years Post-sanative Therapy
NCT number | NCT04639661 |
Other study ID # | 20-070 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | November 25, 2020 |
Est. completion date | October 20, 2021 |
Verified date | November 2021 |
Source | Brock University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 12 |
Est. completion date | October 20, 2021 |
Est. primary completion date | October 20, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Canada | Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery | Fonthill | Ontario |
Canada | Brock University | St. Catharines | Ontario |
Lead Sponsor | Collaborator |
---|---|
Brock University | Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Body Mass Index (BMI) | Patients will self-report their height and weight in an online questionnaire. This information will be used to calculate BMI which is a known risk factor of periodontal disease. | Patients will complete this in an online questionnaire at present day (baseline). | |
Other | Godin Leisure Time Exercise Questionnaire | This questionnaire measures, at one time point, self-reported exercise habits for the past 7 days. This questionnaire includes 4 items and has been combined with the International Physical Activity Questionnaire.
Name of score: Weekly leisure activity score; Minimum score: 0 units and Maximum score: 24 units or more and defined as "active". A higher score indicates a better outcome. |
Patients will complete this in an online questionnaire at present day (baseline). | |
Other | International Physical Activity Questionnaire (IPAQ) | This questionnaire measures, at one time point, self-reported physical activity and sedentary behavior habits. It contains 27 items and has been combined with the Godin Leisure Time Exercise Questionnaire and modified version of the indices of estrogen exposure questionnaire in an online format. They will self-report their physical activity and sedentary behavior for the past 7 days.
Name of score: Weekly physical activity score; Minimum score: 1 and defined as "low physical activity" and Maximumscore: 3 and defined as "high physical activity". A higher score indicates a better outcome. |
Patients will complete this online questionnaire at present day (baseline). | |
Other | Flavonoid and protein intake | Flavonoid and protein intake will be measured with the automated self-administered dietary intake (ASA-24) questionnaire. This is an online food recall that patients will complete three times, reporting on their dietary intake from the last 24 hours. | 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. | |
Other | Lifetime estrogen exposure (LEE) | The indices of estrogen exposure questionnaire will be used to determine LEE using the estimated lifetime estrogen exposure (ELEE) model. The ELEE reflects the reproductive span, comprising a woman's time between age at menarche and age at menopause (or age at recruitment minus age at menarche for pre-menopausal women) minus 1 year for each pregnancy and duration of breastfeeding, calculated at the time at recruitment. | Patients will complete this online questionnaire at present day (baseline). | |
Other | Dietary supplement and tea intake | Intakes of specific dietary supplements and tea will be measured using a dietary supplement and tea intake questionnaire. | Patients will complete this questionnaire online prior to their maintenance appointment | |
Other | COVID-19 Interview questions | Patients will be asked interview questions about changes to their dietary intake, physical activity and oral hygiene habits resulting from the COVID-19 pandemic | Patients will complete these interview questions during their one-on-one virtual meeting with a member of the research team at present day (baseline). | |
Primary | Probing depth | This is a routine clinical measure of periodontal health (measured in mm) | At maintenance appointment (present day) | |
Primary | Probing depth | This is a routine clinical measure of periodontal health (measured in mm) | Pre-sanative therapy | |
Primary | Probing depth | This is a routine clinical measure of periodontal health (measured in mm) | 8-12 weeks post-sanative therapy | |
Primary | Bleeding on probing | This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth | At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards | |
Primary | Bleeding on probing | This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth | Pre-sanative therapy | |
Primary | Bleeding on probing | This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth | 8-12 weeks post-sanative therapy | |
Secondary | Tooth Loss | Will be measured as the number of teeth lost due to periodontal disease | At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards | |
Secondary | Tooth Loss | Will be measured as the number of teeth lost due to periodontal disease | Pre-sanative therapy | |
Secondary | Tooth Loss | Will be measured as the number of teeth lost due to periodontal disease | 8-12 weeks post-sanative therapy | |
Secondary | O'Leary Index of Plaque Control | 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. | At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards | |
Secondary | O'Leary Index of Plaque Control | 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. | Pre-sanative therapy | |
Secondary | O'Leary Index of Plaque Control | 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. | 8-12 weeks post-sanative therapy |
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