Periodontal Maintenance and the COVID-19 Pandemic

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05125835
• Other study ID #: 21-037
• Status: Enrolling by invitation
• Start date: November 21, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: April 2023
• Source: Brock University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: August 31, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Periodontal Diseases
• Periodontal Pocket

Locations

Country	Name	City	State
Canada	Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery	Fonthill	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Brock University	Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing Depth	This is a routine clinical measure of periodontal health (measured in mm)	Pre-sanative therapy
Primary	Probing Depth	This is a routine clinical measure of periodontal health (measured in mm)	8-12 weeks post-sanative therapy
Primary	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	At maintenance appointment (present day) and retrospectively from the clinical record from first maintenance appointment after the 8-12 weeks post-sanative therapy
Primary	Probing Depth	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
Primary	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
Primary	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
Primary	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 first maintenance appointment after the 8-12 weeks post-sanative therapy
Primary	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 hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
Secondary	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.	Pre-sanative therapy
Secondary	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.	8-12 weeks post-sanative therapy
Secondary	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.	At maintenance appointment (present day) and retrospectively from the clinical record from first maintenance appointment after the 8-12 weeks post-sanative therapy
Secondary	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.	At hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously
Secondary	Tooth loss	Will be measured as the number of teeth lost due to periodontal disease	Pre-sanative therapy
Secondary	Tooth loss	Will be measured as the number of teeth lost due to periodontal disease	8-12 weeks post-sanative therapy
Secondary	Tooth loss	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
Secondary	Tooth loss	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