Clinical trial NCT03649789: Periodontal Outcomes After Sanative Therapy
Official title: Retrospective Study of Periodontal Outcomes After Sanative Therapy in Patients With or Without Salivary Gland Hypofunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Pocket
Xerostomia
Dry Mouth
Periodontal Diseases
Keywords: healing
biomarkers
sanative therapy
nutritional supplements
medications
salivary flow
Lead sponsor: Brock University
Sponsor class: OTHER
Collaborators: name: Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
First posted: 2018-08-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who previously underwent sanative therapy to manage periodontal disease at this clinic and who have regular maintenance periodontal cleanings on a regular basis at the clinic.

Brief summary: Salivary gland hypofunction, or dry mouth, is a damaging oral condition that affects salivary gland production. Absence of saliva causes bad breath, dental decay, increased plaque accumulation, dry lips, mouth sores, and the inability to retain dentures or removable protheses. This study will determine if patients with dry mouth have different periodontal health than patients without dry mouth. Additionally, this study will examine if patients who have their periodontal maintenance appointments solely at a periodontal speciality clinic have different periodontal health than patients who alternate their appointments between a specialty office and their general dental office.

Detailed description: Salivary gland hypofunction, or dry mouth, is a damaging oral condition that affects the function and flow rate of saliva. Low saliva rates can range from mild self-reported symptoms and discomfort to significant oral diseases. Saliva is essential in preventing irritation and friction of mucosal surfaces. Progressively dry mouth can cause oral and bodily conditions that can affect an individuals quality of life and daily tasks, such as eating and avoiding social situations. Specifically, dry mouth is a risk factor for periodontal disease, a chronic oral inflammation of tissues and ligaments that support the tooth's structure and if untreated, will ultimately lead to tooth loss. In Canada, the first line of defense against periodontal disease is non-surgical sanative therapy (ST). Participants in this study have been attending a periodontal specialty clinic for routine periodontal maintenance appointments for at least 1 to 5 years following their initial scaling and root planing. Salivary flow rate will be measured to determine the level of dry mouth. At the regular maintenance appointment, clinical measures will be evaluated (probing depth, bleeding on probing, plaque index, gingival index, thickness of tissues, mobility, and furcations). Patients will also complete a dry mouth questionnaire to determine if dry mouth influences the day to day life of a patient, and the patient's Registered Dental Hygienist will complete a short questionnaire outlining oral symptoms of dry mouth. Additionally, the investigators aim to see if a patient who has periodontal maintenance appointments at a specialty office has different clinical outcomes than a patient who alternates these appointments between a specialty office and a general dental office. Overall, the investigators will determine if thorough periodontal maintenance appointments are efficient in preventing periodontal disease in patients with dry mouth.

Eligibility criteria: 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

Primary outcomes:
measure: Probing Depth
timeFrame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
Secondary outcomes:
measure: Bleeding on Probing
timeFrame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
measure: O'Leary Index of Plaque Control
timeFrame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
measure: Gingival Index (used to assess gingival condition to distinguish between the quality of gingiva and the location of gingival concerns).
timeFrame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
measure: Thickness of Periodontal Tissue
timeFrame: At maintenance appointment (1 hour)
measure: Body Mass Index (BMI)
timeFrame: At maintenance appointment (1 hour)
measure: Dry Mouth Inventory Questionnaire Completed by the Patient (to assess impact of dry mouth on quality of life)
timeFrame: At maintenance appointment (1 hour)
measure: The Hygienist Observational Symptom Questionnaire (to assess whether a patient has dry mouth)
timeFrame: At maintenance appointment (1 hour)
measure: Frequency of Periodontal Maintenance Appointment at the Periodontal Clinic and General Dental Clinic
timeFrame: 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)
measure: Frequency of Periodontal Maintenance Appointment only at the Periodontal Clinic
timeFrame: 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)
Other outcomes:
measure: Furcations
timeFrame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
measure: Tooth Mobility
timeFrame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
measure: Salivary Markers of Inflammation
timeFrame: At maintenance appointment (1 hour)
measure: Dietary Supplement Intakes
timeFrame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
Locations:
city: Fonthill
country: Canada
facility: Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
state: Ontario
city: St. Catharines
country: Canada
facility: Brock University
state: Ontario
Study officials:
affiliation: Brock University
name: Wendy E Ward, PhD
role: PRINCIPAL_INVESTIGATOR
References: