Periodontal Outcomes After Sanative Therapy

Periodontal Diseases Clinical Trial

Official title:

Retrospective Study of Periodontal Outcomes After Sanative Therapy in Patients With or Without Salivary Gland Hypofunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03649789
• Other study ID #: 17-387-WARD
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: December 2019
• Source: Brock University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 1, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Mouth
• Periodontal Diseases
• Periodontal Pocket
• Xerostomia

Locations

Country	Name	City	State
Canada	Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery	Fonthill	Ontario
Canada	Brock University	St. Catharines	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
Other	Furcations	Furcations are classified (Class 1 through 3) as amount of bone loss surrounding the root of a tooth.	At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
Other	Tooth Mobility	Tooth Mobility is classified (Class 1 through 3) as amount of support around a tooth.	At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
Other	Salivary Markers of Inflammation	Specific markers of inflammation measured in saliva	At maintenance appointment (1 hour)
Other	Dietary Supplement Intakes	Intakes of specific dietary supplements measured using a dietary supplement questionnaire	At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
Primary	Probing Depth	Probing depth is a routine clinical measure of periodontal health (measured in mm)	At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
Secondary	Bleeding on Probing	Bleeding on Probing is a measure of inflammation and determined as the percent of bleeding sites that are measured at 6 sites per tooth.	At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
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.; 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
Secondary	Gingival Index (used to assess gingival condition to distinguish between the quality of gingiva and the location of gingival concerns).	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
Secondary	Thickness of Periodontal Tissue	Assessment of gingival tissue thickness to assess tissue quality and response to inflammation	At maintenance appointment (1 hour)
Secondary	Body Mass Index (BMI)	Assessment of body weight and height to calculate BMI as it is a known risk factor for periodontal disease	At maintenance appointment (1 hour)
Secondary	Dry Mouth Inventory Questionnaire Completed by the Patient (to assess impact of dry mouth on quality of life)	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)
Secondary	The Hygienist Observational Symptom Questionnaire (to assess whether a patient has dry mouth)	The hygienist records the following about their patient using this questionnaire: Symptoms of dry mouth identified using the following criteria: patient's initial salivation volume and consistency as copious, adequate, slight, or deficient in volume as well as if the consistency is serous, sticky, or frothy. Best outcome is a copious salivary volume and a saliva consistency that is serous. Worst outcome is a deficient saliva volume and a consistency of saliva that is frothy.; Record presence of dental caries, enamel demineralization, tooth hypersensitivity, mucositis, oral candidiasis, traumatic gingival ulcerations, fissure tongue, crenulations on tongue, dry lips, angular chelitis, halitosis, food retention on teeth and/or tongue, or loss of papilla on tongue. All listed outcomes would be considered worst outcomes of dry mouth. Patients would benefit from having none of the above.; Record use of any current treatment for dry mouth.	At maintenance appointment (1 hour)
Secondary	Frequency of Periodontal Maintenance Appointment at the Periodontal Clinic and General Dental Clinic	Frequency of periodontal maintenance appointments at the periodontal clinic and general practice will be recorded.	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)
Secondary	Frequency of Periodontal Maintenance Appointment only at the Periodontal Clinic	Frequency of periodontal maintenance appointments at the periodontal clinic will be recorded.	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)