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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Chronic Periodontitis
• Intervention / Treatment: Procedure: Periodontal Surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0007
      • Unversity of Alabama at Birmingham, School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chronic Periodontitis and Depression Medications; Patients with clinically diagnosed depression taking (SSRIs, NDRIs, SNRIs, tricyclic antidepressants) and with chronic periodontitis	Procedure: 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.
Active Comparator: Chronic Periodontitis without Depression Medications; Patients with clinically diagnosed depression not taking any antidepressants (SSRIs NDRIs, SNRIs and Tricyclic antidepressants) and with chronic periodontitis	Procedure: 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.
Active Comparator: Chronic Periodontitis; Patients without depression, not taking any antidepressants and with chronic periodontitis	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival crevicular fluid (GCF)	Measuring oral inflammatory markers in Gingival crevicular fluid (GCF) in patient with chronic periodontitis.	baseline to 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque	Analyze the type of bacteria that is present in patient with chronic periodontitis.	baseline to 1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft tissue	Analyze the immune cells in patient with chronic periodontitis.	baseline to 1 week
Blood Serum	Analyze the systemic inflammatory markers in patient with chronic periodontitis.	baseline to 1 week
Patient Health Questionnaire 8 (PHQ8)	Measure depression status in patient with chronic periodontitis.	baseline to 1 week

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2018
• Primary Completion (Actual): December 30, 2019
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: May 29, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Estimated): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Behavioral Symptoms; Periodontitis; Pathological Conditions, Signs and Symptoms; Behavior; Depression; Chronic Periodontitis
• Other Study ID Numbers: IRB-300000426; UAB-Perio (Other Identifier: University of Alabama at Birmingham)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No