Clinical trial NCT03553095: Comparing Inflammatory Markers in Patients With and Without Depression With Chronic Periodontitis
Official title: Comparing Inflammatory Markers in Patients With and Without Depression With Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Periodontitis
Depression
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate whether use of antidepressants can reduce gingival inflammation in patients with periodontal (gum) disease.

Detailed description: The primary purpose of this study is to evaluate whether use of antidepressants can reduce gingival inflammation in patients with periodontal (gum) disease. This study will also investigate the link between oral and systemic inflammation in patients diagnosed with depression and periodontal disease. Researcher will collect gingival crevicular fluid, plaque, tissue and blood serum samples to evaluate the link between these two diseases. The collection of gingival crevicular fluid, plaque and blood serum is relatively non-invasive, elicits minimal discomfort and does not require use of any anesthesia. The soft tissue sample will be collected as part of an otherwise planned periodontal surgical procedure under local anesthesia. In periodontal therapy (surgical procedures i.e. gum surgery, tooth extraction and or dental implant surgery) there is enough availability of remnant tissue for the collection of samples, which is otherwise discarded.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Must be a patient of the UAB Dental School
* Able to read and understand informed consent document
* Good general health as evidenced by medical history
* Minimum of 18 teeth, excluding third molars
* Having moderate to severe periodontal disease according to AAP definition (teeth ≥5 mm PD and ≥3 mm CAL)
* Having \>30 percent bleeding sites upon probing
* Patients taking depression medication with chronic periodontitis
* Patients without depression with chronic periodontitis
* Patients who have not had a dental cleaning in the past 3 months prior to procedure
* Patients scheduled for surgical procedures (i.e. gum surgery, tooth extraction, or dental implants)

Exclusion Criteria:

* Non-English speaking
* Less than 18 years old
* Smokers/tobacco users (\>10 cigarettes/day)
* Any dental condition that requires immediate treatment, such as emergency care
* Chronic use (≥3 times/week) of anti-inflammatory medications (e.g., non-steroidal anti-inflammatory drugs, steroids). Low-dose aspirin (less than 325 mg daily)
* Immunocompromised subjects
* Any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues, such as uncontrolled diabetes, nifedipine, phenytoin (Dilantin), subjects with arthritis and morbidly obese (BMI ≥ 40)

Primary outcomes:
measure: Gingival crevicular fluid (GCF)
timeFrame: baseline to 1 week
Secondary outcomes:
measure: Plaque
timeFrame: baseline to 1 week
Other outcomes:
measure: Soft tissue
timeFrame: baseline to 1 week
measure: Blood Serum
timeFrame: baseline to 1 week
measure: Patient Health Questionnaire 8 (PHQ8)
timeFrame: baseline to 1 week
Locations:
city: Birmingham
country: United States
facility: Unversity of Alabama at Birmingham, School of Dentistry
state: Alabama
Study officials:
References: