- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03649789
Periodontal Outcomes After Sanative Therapy
Retrospective Study of Periodontal Outcomes After Sanative Therapy in Patients With or Without Salivary Gland Hypofunction
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Fonthill, Ontario, Canada, L0S1E5
- Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
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St. Catharines, Ontario, Canada, L2S3A1
- Brock University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- have had sanative therapy at this clinic in the previous 1 to 5 years.
Exclusion Criteria:
- anyone who is unable to provide informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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No Salivary Gland Hypofunction
These individuals have an unstimulated salivary flow rate of greater than 0.1 mL saliva/min.
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Salivary Gland Hypofunction
These individuals have an unstimulated salivary flow rate of less than 0.1 mL saliva/min.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probing Depth
Time Frame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
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Probing depth is a routine clinical measure of periodontal health (measured in mm)
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At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bleeding on Probing
Time Frame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
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Bleeding on Probing is a measure of inflammation and determined as the percent of bleeding sites that are measured at 6 sites per tooth.
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At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
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O'Leary Index of Plaque Control
Time Frame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
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The patient's plaque index = the number of plaque-containing surfaces divided by the total number of available surfaces. For instance, if a patient has 28 teeth they have 112 tooth surfaces (28x4=112) and if 40 surfaces contain plaque their plaque index is 40/112=0.357 or 35.7%. 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 contain plaque. The optimal outcome is to have a plaque index of 0%. The worst outcome would be a plaque index of 100%. |
At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
|
Gingival Index (used to assess gingival condition to distinguish between the quality of gingiva and the location of gingival concerns).
Time Frame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
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The gingival index system consists of 4 possible ratings: 0 = Normal gingiva, 1 = mild inflammation with a slight change in colour, slight edema (no bleeding on probing); 2 = moderate inflammation with redness, edmea and glazing (bleeding on probing); or 3 = severe inflammation with marked redness and edema, ulceration, tendency to spontaneous bleeding. Each four gingival areas of a tooth is given a score from 0 to 3. This corresponds to the gingival index for that area. The scores from the four areas of the tooth can be added and divided by four to give the gingival index for the tooth. The better outcome is having a gingival index of 0, the worst outcome is having a gingival outcome of 3. |
At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
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Thickness of Periodontal Tissue
Time Frame: At maintenance appointment (1 hour)
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Assessment of gingival tissue thickness to assess tissue quality and response to inflammation
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At maintenance appointment (1 hour)
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Body Mass Index (BMI)
Time Frame: At maintenance appointment (1 hour)
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Assessment of body weight and height to calculate BMI as it is a known risk factor for periodontal disease
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At maintenance appointment (1 hour)
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Dry Mouth Inventory Questionnaire Completed by the Patient (to assess impact of dry mouth on quality of life)
Time Frame: At maintenance appointment (1 hour)
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This questionnaire measures, at one time point, the self-reported daily limitations due to dry mouth. This inventory questionnaire includes 11 criteria and the questionnaire is completed by the patient. The 11 criteria include: I sip liquids to aid in swallowing food; My mouth feels dry when eating a meal; I get up at night to drink; My mouth feels dry; I have difficulty in eating dry foods; I suck sweets or cough lollies to relieve dry mouth; I have difficulties swallowing certain foods; The skin on my face feels dry; My eyes feel dry; My lips feel dry; The inside of my nose feels dry. For each of the criteria, patients will also rate the frequency by which having a dry mouth limits their daily functions according to the following description: "never", "hardly ever", "occasionally", "fairly often", "very often" |
At maintenance appointment (1 hour)
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The Hygienist Observational Symptom Questionnaire (to assess whether a patient has dry mouth)
Time Frame: At maintenance appointment (1 hour)
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The hygienist records the following about their patient using this questionnaire:
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At maintenance appointment (1 hour)
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Frequency of Periodontal Maintenance Appointment at the Periodontal Clinic and General Dental Clinic
Time Frame: Will be reviewed from patient's clinical record over a time period of 1 to 5 years (this will represent the time period from recruitment and retrospectively until the time at which sanative therapy was performed)
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Frequency of periodontal maintenance appointments at the periodontal clinic and general practice will be recorded.
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Will be reviewed from patient's clinical record over a time period of 1 to 5 years (this will represent the time period from recruitment and retrospectively until the time at which sanative therapy was performed)
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Frequency of Periodontal Maintenance Appointment only at the Periodontal Clinic
Time Frame: Will be reviewed from patient's clinical record over a time period of 1 to 5 years (this will represent the time period from recruitment and retrospectively until the time at which sanative therapy was performed)
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Frequency of periodontal maintenance appointments at the periodontal clinic will be recorded.
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Will be reviewed from patient's clinical record over a time period of 1 to 5 years (this will represent the time period from recruitment and retrospectively until the time at which sanative therapy was performed)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Furcations
Time Frame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
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Furcations are classified (Class 1 through 3) as amount of bone loss surrounding the root of a tooth.
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At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
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Tooth Mobility
Time Frame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
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Tooth Mobility is classified (Class 1 through 3) as amount of support around a tooth.
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At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
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Salivary Markers of Inflammation
Time Frame: At maintenance appointment (1 hour)
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Specific markers of inflammation measured in saliva
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At maintenance appointment (1 hour)
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Dietary Supplement Intakes
Time Frame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
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Intakes of specific dietary supplements measured using a dietary supplement questionnaire
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At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wendy E Ward, PhD, Brock University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-387-WARD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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