Clinical trial NCT05125835: Periodontal Maintenance and the COVID-19 Pandemic
Official title: Long-Term Periodontal Outcomes in Males and Females Following Sanative Therapy or Regular Hygiene Appointments and COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontal Diseases
Periodontal Pocket
Keywords: Periodontal therapy
Periodontal maintenance
Hygiene appointment
Sanative therapy
COVID-19
Lead sponsor: Brock University
Sponsor class: OTHER
Collaborators: name: Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
First posted: 2021-11-18
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who have undergone either sanative therapy plus at least one maintenance appointment or who attend regular hygiene appointments at this clinic.

Brief summary: Periodontal disease is a chronic condition affecting the teeth and surrounding support structures, characterized by tooth loss and alveolar bone loss. Sanative therapy (ST) is the gold standard non-surgical treatment for periodontal disease and involves mechanically removing the subgingival bacteria from the periodontal pockets. Regular periodontal maintenance appointments are needed to maintain periodontal health after ST. Moreover, the periodontal health of individuals not requiring ST is also dependent on regular hygiene appointments. Due to Ontario's March 2020 COVID-19-related clinic closure for approximately 3 months along with a reduced numbers of appointments available due to guidelines of professional bodies and public health beyond this period of time, many appointments were considerably delayed or cancelled. The effects of this disruption to periodontal health in male and female patients who have undergone ST and continue with maintenance appointments or who attend for regular hygiene appointments have not yet been investigated.

Detailed description: Sanative therapy (ST) is often the first line of treatment following a diagnosis of periodontal disease. By mechanically removing the inflammation-inducing bacteria below the gum line, a more controlled state of periodontal health can be achieved. Improvements in periodontal health achieved through ST can be maintained long-term with regular maintenance appointments that aid in preventing further progression of the disease. However, due to the government-mandated clinic closure in March 2020 of dental offices for all but emergency in-person care in Canada due to the COVID-19 pandemic, clinics were shut down for approximately 3 months with a reduced availability of appointments in the following year due to professional guidelines. Regular hygiene appointments (cleanings) were also considerably delayed or cancelled. This disruption in routine care, accompanied with the potential exacerbation of various risk factors for periodontal disease such as stress, diet, physical activity, and smoking or alcohol use brought on by the pandemic has not yet been investigated pertaining to the effect on clinical periodontal outcomes. The main objective of this study is to determine if delays in regularly scheduled maintenance or regular hygiene appointments caused by COVID-19 impacted clinical periodontal outcomes in male and female patients. Secondary objectives include retrospectively determining the long-term clinical outcomes of patients who underwent periodontal therapy or who have had regular hygiene appointments at the clinic; comparing the long-term periodontal outcomes of patients who undergo maintenance appointments and those who receive only regular hygiene appointments; and examining whether there exists a sex-specific response to either treatment. Periodontal outcomes of interest include probing depth, bleeding on probing, plaque index, and tooth loss.

Eligibility criteria: Inclusion Criteria:

* Have undergone sanative therapy or attend regular hygiene appointments at the clinic
* Age 19 years or older
* Willing and able to provide informed consent

Exclusion Criteria:

* Age \< 19 years
* Unable to provide informed consent

Primary outcomes:
measure: Probing Depth
timeFrame: Pre-sanative therapy
measure: Probing Depth
timeFrame: 8-12 weeks post-sanative therapy
measure: Probing Depth
timeFrame: At maintenance appointment (present day) and retrospectively from the clinical record from first maintenance appointment after the 8-12 weeks post-sanative therapy
measure: Probing Depth
timeFrame: At hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
measure: Bleeding on Probing
timeFrame: Pre-sanative therapy
measure: Bleeding on Probing
timeFrame: 8-12 weeks post-sanative therapy
measure: Bleeding on Probing
timeFrame: At maintenance appointment (present day) and retrospectively from the clinical record from first maintenance appointment after the 8-12 weeks post-sanative therapy
measure: Bleeding on Probing
timeFrame: At hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
Secondary outcomes:
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
measure: O'Leary Index of Plaque Control
timeFrame: At maintenance appointment (present day) and retrospectively from the clinical record from first maintenance appointment after the 8-12 weeks post-sanative therapy
measure: O'Leary Index of Plaque Control
timeFrame: At hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
measure: Tooth loss
timeFrame: Pre-sanative therapy
measure: Tooth loss
timeFrame: 8-12 weeks post-sanative therapy
measure: Tooth loss
timeFrame: At maintenance appointment (present day) and retrospectively from the clinical record from first maintenance appointment after the 8-12 weeks post-sanative therapy
measure: Tooth loss
timeFrame: At hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
Other outcomes:
Locations:
city: Fonthill
country: Canada
facility: Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
state: Ontario
Study officials:
affiliation: Brock University
name: Wendy E Ward, PhD
role: PRINCIPAL_INVESTIGATOR
References: