NCT05125835

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
428

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

November 21, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

November 15, 2021

Last Update Submit

August 8, 2025

Conditions

Keywords

Periodontal therapyPeriodontal maintenanceHygiene appointmentSanative therapyCOVID-19

Outcome Measures

Primary Outcomes (8)

  • Probing Depth

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

    Pre-sanative therapy

  • Probing Depth

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

    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

    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

    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.

    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.

    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.

    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.

    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

    Pre-sanative therapy

  • O'Leary Index of Plaque Control

    8-12 weeks post-sanative therapy

  • O'Leary Index of Plaque Control

    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

    At hygiene appointment (present day) and retrospectively from the clinical record from first hygiene appointment at clinic, up to 17 years previously

  • Tooth loss

    Pre-sanative therapy

  • +3 more secondary outcomes

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Fonthill, Ontario, L0S1E5, Canada

Location

MeSH Terms

Conditions

Periodontal DiseasesPeriodontal PocketCOVID-19

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesPeriodontitisPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Wendy E Ward, PhD

    Brock University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Canada Research Chair

Study Record Dates

First Submitted

November 15, 2021

First Posted

November 18, 2021

Study Start

November 21, 2021

Primary Completion

March 30, 2023

Study Completion

August 31, 2023

Last Updated

August 13, 2025

Record last verified: 2025-08

Locations