Periodontal DiseasesNCT04639661
Predictors of Periodontal Outcomes Post-sanative Therapy
An observational study of Periodontal Diseases and Periodontal Pocket, run by Brock University at 2 sites in Canada.
Trial summary
Periodontal disease is a chronic inflammatory disease of the tissues surrounding the teeth and is one of the leading causes of tooth loss. Sanative therapy (ST) is a non-surgical procedure that allows for removal of bacteria from the deep pockets that form around teeth and is the frontline treatment for periodontal… 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
- 12 participants
- Where
- 2 sitesCanada
- Study dates
- 25 Nov 2020to 20 Oct 2021
- 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 underwent sanative therapy to manage periodontal disease at this clinic 5 to 10 years before present-day appointment. Only patients who have maintained regular maintenance appointments after receiving sanative therapy will be eligible.
Who may be able to join
- Have undergone sanative therapy (ST) in the past 5 to 10 years
- Age > 19 years
- Willingness and ability to provide informed consent. Participants must be able and willing to complete online questionnaires from home and give permission for access to their periodontal records from the time of their sanative therapy to present day
Who cannot join
- Individuals with physical or mental limitations that inhibit them from conducting their own personal oral hygiene (oral hygiene is a key component in maintaining periodontal health)
- Women who are currently pregnant or breastfeeding (hormonal changes during pregnancy are known to cause gingival inflammation)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
Fonthill, Ontario, L0S1E5
Brock University
St. Catharines, Ontario, L2S3A1
About this study
Official title: Predictors of Periodontal Outcomes in Patients 5 to 10 Years Post-sanative Therapy
Periodontal disease is a chronic inflammatory disease of the tissues surrounding the teeth and is one of the leading causes of tooth loss. Sanative therapy (ST) is a non-surgical procedure that allows for removal of bacteria from the deep pockets that form around teeth and is the frontline treatment for periodontal disease. Post-ST, patients require ongoing maintenance appointments to maintain their oral health, though whether risk factors for periodontal disease remain a predictor of periodontal health post-ST has not been comprehensively investigated. Risk factors to be examined include physical activity, exercise, sedentary time, flavonoid intake, protein intake, BMI, sex, age, smoking status, and number of sites with periodontal probing depth (PPD) ≥ 4mm at baseline.
Read the detailed description
Periodontal disease is a main cause of tooth loss. Patients with periodontal disease may receive sanative therapy (ST), a deep cleaning of the teeth that helps prevent the progression of periodontal disease. Post-ST, maintenance appointments are an important part of the strategy used to help these patients prevent the progression of periodontal disease and maintain their periodontal health. Given that numerous chronic diseases, obesity, low levels of physical activity, being a smoker, poor diet, and older age are all risk factors for periodontal disease, these factors may also be predictive of worse periodontal health 5 to 10 years post-ST. Many modifiable periodontal risk factors such a physical activity, exercise, and obesity have not been studied in relation to periodontal outcomes post-ST, and other factors such as diet, sex and age have not been comprehensively studied. The primary objective of this study is to determine, at 5 to 10 years post-ST, if physical activity, exercise, sedentary time, flavonoid intake, protein intake, BMI, sex, age, smoking status, and number of sites with periodontal probing depth (PPD) ≥ 4 mm at baseline are significant predictors of periodontal health. A secondary objective is to determine if lifetime estrogen exposure impacts periodontal health in women. Periodontal health will be measured using probing depth, tooth loss, bleeding on probing and plaque index. Established questionnaires will be used to assess dietary intake, physical activity and sedentary behaviour. Within the study the investigators will also assess if and how a patient's periodontal health has been impacted by clinic closures and rescheduling of maintenance appointments that were mandated by regulatory organizations as a result of the COVID-19 pandemic. The investigators will also ask questions about changes in diet, physical activity and oral hygiene during COVID-19.
- Conditions
- Periodontal Diseases, Periodontal Pocket
- Keywords
- Periodontal therapy, Flavonoids, Tea, Dietary intake, Supplements, Physical activity, Exercise, Sedentary time, Estrogen, Lifetime estrogen exposure, Periodontal maintenance
- Medical subject headings
- Periodontal Diseases, Periodontal Pocket, Motor Activity, Sedentary Behavior
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: At maintenance appointment (present day)
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
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 the time of sanative therapy (5 to 10 years ago) onwards
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
Secondary outcomes (6)
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 the time of sanative therapy (5 to 10 years ago) onwards
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
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 the time of sanative therapy (5 to 10 years ago) onwards
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start25 Nov 2020
- Primary completion20 Oct 2021
- Study completion20 Oct 2021
Why it stopped: Challenges with recruiting patients during the COVID-19 pandemic.
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
- 12 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
- NCT04639661
- Sponsor's protocol ID
- 20-070
- Status last verified
- Nov 2021
- First submitted
- 9 Nov 2020
- Last updated
- 23 Nov 2021
- 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 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Periodontal Outcomes in Patients 5 to 10 Years Post-sanative Therapy
- ClinicalTrials.gov ID
- NCT04639661
- Acronym / sponsor ID
- 20-070
- Conditions
- Periodontal Diseases, Periodontal Pocket
- Keywords
- Periodontal therapy, Flavonoids, Tea, Dietary intake, Supplements, Physical activity, Exercise, Sedentary time
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Challenges with recruiting patients during the COVID-19 pandemic.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Collaborators
- Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 20 Nov 2020 (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 inflammatory disease of the tissues surrounding the teeth and is one of the leading causes of tooth loss. Sanative therapy (ST) is a non-surgical procedure that allows for removal of bacteria from the deep pockets that form around teeth and is the frontline treatment for periodontal disease. Post-ST, patients require ongoing maintenance appointments to maintain their oral health, though whether risk factors for periodontal disease remain a predictor of periodontal health post-ST has not been comprehensively investigated. Risk factors to be examined include physical activity, exercise, sedentary time, flavonoid intake, protein intake, BMI, sex, age, smoking status, and number of sites with periodontal probing depth (PPD) ≥ 4mm at baseline.
Detailed description
Periodontal disease is a main cause of tooth loss. Patients with periodontal disease may receive sanative therapy (ST), a deep cleaning of the teeth that helps prevent the progression of periodontal disease. Post-ST, maintenance appointments are an important part of the strategy used to help these patients prevent the progression of periodontal disease and maintain their periodontal health. Given that numerous chronic diseases, obesity, low levels of physical activity, being a smoker, poor diet, and older age are all risk factors for periodontal disease, these factors may also be predictive of worse periodontal health 5 to 10 years post-ST. Many modifiable periodontal risk factors such a physical activity, exercise, and obesity have not been studied in relation to periodontal outcomes post-ST, and other factors such as diet, sex and age have not been comprehensively studied. The primary objective of this study is to determine, at 5 to 10 years post-ST, if physical activity, exercise, sedentary time, flavonoid intake, protein intake, BMI, sex, age, smoking status, and number of sites with periodontal probing depth (PPD) ≥ 4 mm at baseline are significant predictors of periodontal health. A secondary objective is to determine if lifetime estrogen exposure impacts periodontal health in women. Periodontal health will be measured using probing depth, tooth loss, bleeding on probing and plaque index. Established questionnaires will be used to assess dietary intake, physical activity and sedentary behaviour. Within the study the investigators will also assess if and how a patient's periodontal health has been impacted by clinic closures and rescheduling of maintenance appointments that were mandated by regulatory organizations as a result of the COVID-19 pandemic. The investigators will also ask questions about changes in diet, physical activity and oral hygiene during COVID-19.
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 underwent sanative therapy to manage periodontal disease at this clinic 5 to 10 years before present-day appointment. Only patients who have maintained regular maintenance appointments after receiving sanative therapy will be eligible.
Key inclusion criteria (3 listed)
- Have undergone sanative therapy (ST) in the past 5 to 10 years
- Age > 19 years
- Willingness and ability to provide informed consent. Participants must be able and willing to complete online questionnaires from home and give permission for access to their periodontal records from the time of their sanative therapy to present day
Key exclusion criteria (2 listed)
- Individuals with physical or mental limitations that inhibit them from conducting their own personal oral hygiene (oral hygiene is a key component in maintaining periodontal health)
- Women who are currently pregnant or breastfeeding (hormonal changes during pregnancy are known to cause gingival inflammation)
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: At maintenance appointment (present day)
This is a routine clinical measure of periodontal health (measured in mm)
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)
Bleeding on probing
Time frame: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
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: 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
6 secondary outcomes
Tooth Loss
Time frame: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
Tooth Loss
Time frame: Pre-sanative therapy
Tooth Loss
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 the time of sanative therapy (5 to 10 years ago) onwards
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
Results and safety
The study was stopped early (reason given: Challenges with recruiting patients during the COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- 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
2 sites 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 2 sites 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: stopped early, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Challenges with recruiting patients during the COVID-19 pandemic.). Results are not available in the source record.
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: At maintenance appointment (present day)). The study lists 6 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 23 Nov 2021.