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

NCT ID: NCT03553095

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2026-12-30

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.

Conditions

Chronic Periodontitis; Depression

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Chronic Periodontitis and Depression Medications

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

Group Type: ACTIVE_COMPARATOR

Periodontal Surgery

Intervention Type: PROCEDURE

Samples will be collected from patient in need of periodontal therapy (surgical procedures i.e. gum surgery, tooth extraction and or dental implant surgery). As standard during this procedures remnant tissue is otherwise discarded.

Chronic Periodontitis without Depression Medications

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

Group Type: ACTIVE_COMPARATOR

Periodontal Surgery

Intervention Type: PROCEDURE

Samples will be collected from patient in need of periodontal therapy (surgical procedures i.e. gum surgery, tooth extraction and or dental implant surgery). As standard during this procedures remnant tissue is otherwise discarded.

Chronic Periodontitis

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

Group Type: ACTIVE_COMPARATOR

Periodontal Surgery

Intervention Type: PROCEDURE

Samples will be collected from patient in need of periodontal therapy (surgical procedures i.e. gum surgery, tooth extraction and or dental implant surgery). As standard during this procedures remnant tissue is otherwise discarded.

Interventions

Periodontal Surgery

Samples will be collected from patient in need of periodontal therapy (surgical procedures i.e. gum surgery, tooth extraction and or dental implant surgery). As standard during this procedures remnant tissue is otherwise discarded.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Maninder Kaur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Unversity of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

UAB-Perio

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-300000426

Identifier Type: -

Identifier Source: org_study_id