Predictors of Periodontal Outcomes Post-sanative Therapy

NCT04639661 | Terminated

• 1 other identifier: 20-070
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Periodontal Diseases; Periodontal Pocket

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Probing depth

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

  At maintenance appointment (present day)

• Probing depth

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

  Pre-sanative therapy

• Probing depth

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

  8-12 weeks post-sanative therapy

• 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

• 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

• 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 Outcomes (6)

• Tooth Loss

  At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards

• Tooth Loss

  Pre-sanative therapy

• Tooth Loss

  8-12 weeks post-sanative therapy

• O'Leary Index of Plaque Control

  At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards

• O'Leary Index of Plaque Control

  Pre-sanative therapy

Other Outcomes (7)

• Body Mass Index (BMI)

  Patients will complete this in an online questionnaire at present day (baseline).

• Godin Leisure Time Exercise Questionnaire

  Patients will complete this in an online questionnaire at present day (baseline).

• International Physical Activity Questionnaire (IPAQ)

  Patients will complete this online questionnaire at present day (baseline).

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brock University: lead
• Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery: collaborator

Study Sites (2)

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

Fonthill, Ontario, L0S1E5, Canada

Location

Brock University

St. Catharines, Ontario, L2S3A1, Canada

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontal Pocket; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis; Behavior

Study Officials

• Wendy E Ward, PhD

  Brock University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 20, 2020
• Study Start: November 25, 2020
• Primary Completion: October 20, 2021
• Study Completion: October 20, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

CA (2)