Comparing Inflammatory Markers in Patients With and Without Depression With Chronic Periodontitis

The University of Alabama at Birmingham

Status: Active, not recruiting

Conditions: Chronic Periodontitis; Depression

Treatments: Procedure: Periodontal Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03553095

UAB-Perio (Other Identifier)

IRB-300000426

Details and patient eligibility

About

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

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 3 patient groups

Chronic Periodontitis and Depression Medications

Active Comparator group

Description:

Patients with clinically diagnosed depression taking (SSRIs, NDRIs, SNRIs, tricyclic antidepressants) and with chronic periodontitis

Treatment:

Procedure: Periodontal Surgery

Chronic Periodontitis without Depression Medications

Active Comparator group

Description:

Patients with clinically diagnosed depression not taking any antidepressants (SSRIs NDRIs, SNRIs and Tricyclic antidepressants) and with chronic periodontitis

Treatment:

Procedure: Periodontal Surgery

Chronic Periodontitis

Active Comparator group

Description:

Patients without depression, not taking any antidepressants and with chronic periodontitis

Treatment:

Procedure: Periodontal Surgery