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OpenTrials
Completed

NCT Number: NCT05125835

Periodontal Maintenance and the COVID-19 Pandemic

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.

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Key information

Conditions

Periodontal Diseases COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mouth Diseases Nidovirales Infections Periodontal Pocket Periodontitis Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases Virus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Fonthill, Ontario, L0S1E5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Probing Depth

    Time frame: Pre-sanative therapy

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

  2. Probing Depth

    Time frame: 8-12 weeks post-sanative therapy

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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Tooth loss

    Time frame: Pre-sanative therapy

    Will be measured as the number of teeth lost due to periodontal disease

  6. Tooth loss

    Time frame: 8-12 weeks post-sanative therapy

    Will be measured as the number of teeth lost due to periodontal disease

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Brock University

Other

Collaborators

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

Registry information

Official study title

Long-Term Periodontal Outcomes in Males and Females Following Sanative Therapy or Regular Hygiene Appointments and COVID-19

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2021
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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