- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05125835
Periodontal Maintenance and the COVID-19 Pandemic
August 8, 2025 updated by: Wendy E. Ward, Ph.D., Brock University
Long-Term Periodontal Outcomes in Males and Females Following Sanative Therapy or Regular Hygiene Appointments and COVID-19
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
428
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
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Fonthill, Ontario, Canada, L0S1E5
- Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Probing Depth
Time Frame: Pre-sanative therapy
|
This is a routine clinical measure of periodontal health (measured in mm)
|
Pre-sanative therapy
|
|
Probing Depth
Time Frame: 8-12 weeks post-sanative therapy
|
This is a routine clinical measure of periodontal health (measured in mm)
|
8-12 weeks post-sanative therapy
|
|
Probing Depth
Time Frame: At maintenance appointment (present day) and retrospectively from the clinical record from first maintenance appointment after the 8-12 weeks post-sanative therapy
|
This is a routine clinical measure of periodontal health (measured in mm) for patients who attend the clinic for maintenance appointments after sanative therapy
|
At maintenance appointment (present day) and retrospectively from the clinical record from first maintenance appointment after the 8-12 weeks post-sanative therapy
|
|
Probing Depth
Time Frame: At hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
|
This is a routine clinical measure of periodontal health (measured in mm) in patients who attend the clinic for regular hygiene appointments
|
At hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
|
|
Bleeding on Probing
Time Frame: Pre-sanative therapy
|
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
Time Frame: 8-12 weeks post-sanative therapy
|
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
|
|
Bleeding on Probing
Time Frame: At maintenance appointment (present day) and retrospectively from the clinical record from first maintenance appointment after the 8-12 weeks post-sanative therapy
|
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 first maintenance appointment after the 8-12 weeks post-sanative therapy
|
|
Bleeding on Probing
Time Frame: At hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
|
This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth.
|
At hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
O'Leary Index of Plaque Control
Time Frame: Pre-sanative therapy
|
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
|
|
O'Leary Index of Plaque Control
Time Frame: 8-12 weeks post-sanative therapy
|
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
|
|
O'Leary Index of Plaque Control
Time Frame: At maintenance appointment (present day) and retrospectively from the clinical record from first maintenance appointment after the 8-12 weeks post-sanative therapy
|
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 first maintenance appointment after the 8-12 weeks post-sanative therapy
|
|
O'Leary Index of Plaque Control
Time Frame: At hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
|
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 hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
|
|
Tooth loss
Time Frame: Pre-sanative therapy
|
Will be measured as the number of teeth lost due to periodontal disease
|
Pre-sanative therapy
|
|
Tooth loss
Time Frame: 8-12 weeks post-sanative therapy
|
Will be measured as the number of teeth lost due to periodontal disease
|
8-12 weeks post-sanative therapy
|
|
Tooth loss
Time Frame: At maintenance appointment (present day) and retrospectively from the clinical record from first maintenance appointment after the 8-12 weeks post-sanative therapy
|
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 first maintenance appointment after the 8-12 weeks post-sanative therapy
|
|
Tooth loss
Time Frame: At hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
|
Will be measured as the number of teeth lost due to periodontal disease
|
At hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wendy E Ward, PhD, Brock University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2021
Primary Completion (Actual)
March 30, 2023
Study Completion (Actual)
August 31, 2023
Study Registration Dates
First Submitted
November 15, 2021
First Submitted That Met QC Criteria
November 16, 2021
First Posted (Actual)
November 18, 2021
Study Record Updates
Last Update Posted (Actual)
August 13, 2025
Last Update Submitted That Met QC Criteria
August 8, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mouth Diseases
- Stomatognathic Diseases
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Periodontitis
- COVID-19
- Periodontal Diseases
- Periodontal Pocket
Other Study ID Numbers
- 21-037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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