Periodontal DiseasesNCT05125835
Periodontal Maintenance and the COVID-19 Pandemic
An observational study of Periodontal Diseases and Periodontal Pocket, run by Brock University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Periodontal Diseases, Periodontal Pocket
- How many people
- 428 participants
- Where
- 1 siteCanada
- Study dates
- 21 Nov 2021to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Have undergone sanative therapy or attend regular hygiene appointments at the clinic
- Age 19 years or older
- Willing and able to provide informed consent
Who cannot join
- Age < 19 years
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
Fonthill, Ontario, L0S1E5
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontal Diseases, Periodontal Pocket
- Keywords
- Periodontal therapy, Periodontal maintenance, Hygiene appointment, Sanative therapy, COVID-19
- Medical subject headings
- Periodontal Diseases, Periodontal Pocket, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth
This is a routine clinical measure of periodontal health (measured in mm)
Measured: Pre-sanative therapy
Probing Depth
This is a routine clinical measure of periodontal health (measured in mm)
Measured: 8-12 weeks post-sanative therapy
Probing Depth
This is a routine clinical measure of periodontal health (measured in mm) for patients who attend the clinic for maintenance appointments after sanative therapy
Measured: 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
This is a routine clinical measure of periodontal health (measured in mm) in patients who attend the clinic for regular hygiene appointments
Measured: 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
This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth.
Measured: 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.
Measured: 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.
Measured: 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
This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth.
Measured: At hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
Secondary outcomes (8)
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.
Measured: Pre-sanative therapy
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.
Measured: 8-12 weeks post-sanative therapy
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.
Measured: 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
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.
Measured: At hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
Tooth loss
Will be measured as the number of teeth lost due to periodontal disease
Measured: Pre-sanative therapy
Tooth loss
Will be measured as the number of teeth lost due to periodontal disease
Measured: 8-12 weeks post-sanative therapy
Tooth loss
Will be measured as the number of teeth lost due to periodontal disease
Measured: 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
Will be measured as the number of teeth lost due to periodontal disease
Measured: At hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start21 Nov 2021
- Primary completion30 Mar 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
- Responsible party
- Principal investigator, Wendy E. Ward, Ph.D., Brock University
- Investigators
- Wendy E Ward, PhD, Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125835
- Sponsor's protocol ID
- 21-037
- Status last verified
- Aug 2025
- First submitted
- 15 Nov 2021
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Periodontal Outcomes in Males and Females Following Sanative Therapy or Regular Hygiene Appointments and COVID-19
- ClinicalTrials.gov ID
- NCT05125835
- Acronym / sponsor ID
- 21-037
- Conditions
- Periodontal Diseases, Periodontal Pocket
- Keywords
- Periodontal therapy, Periodontal maintenance, Hygiene appointment, Sanative therapy, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Collaborators
- Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
- Study start
- 21 Nov 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Have undergone sanative therapy or attend regular hygiene appointments at the clinic
- Age 19 years or older
- Willing and able to provide informed consent
Key exclusion criteria (2 listed)
- Age < 19 years
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Probing Depth
Time frame: Pre-sanative therapy
This is a routine clinical measure of periodontal health (measured in mm)
Probing Depth
Time frame: 8-12 weeks post-sanative therapy
This is a routine clinical measure of periodontal health (measured in mm)
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
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
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.
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.
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.
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.
8 secondary outcomes
O'Leary Index of Plaque Control
Time frame: Pre-sanative therapy
O'Leary Index of Plaque Control
Time frame: 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
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
Tooth loss
Time frame: Pre-sanative therapy
Tooth loss
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy E Ward, PhD principal investigator
Brock University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Periodontal Pocket, run by Brock University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Depth (time frame: Pre-sanative therapy). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.