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

NCT03553095 | Active Not Recruiting

• 2 other identifiers: IRB-300000426UAB-Perio
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Periodontitis; Depression

Outcome Measures

Primary Outcomes (1)

• Gingival crevicular fluid (GCF)

  Measuring oral inflammatory markers in Gingival crevicular fluid (GCF) in patient with chronic periodontitis.

  baseline to 1 week

Secondary Outcomes (1)

• Plaque

  baseline to 1 week

Other Outcomes (3)

• Soft tissue

  baseline to 1 week

• Blood Serum

  baseline to 1 week

• Patient Health Questionnaire 8 (PHQ8)

  baseline to 1 week

Study Arms (3)

Chronic Periodontitis and Depression Medications

ACTIVE COMPARATOR

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

Procedure: Periodontal Surgery

Chronic Periodontitis without Depression Medications

ACTIVE COMPARATOR

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

Procedure: Periodontal Surgery

Chronic Periodontitis

ACTIVE COMPARATOR

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

Procedure: Periodontal Surgery

Interventions

Periodontal Surgery 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; Chronic Periodontitis and Depression Medications; Chronic Periodontitis without Depression Medications

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Unversity of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, 35294-0007, United States

Location

MeSH Terms

Conditions

Chronic Periodontitis; Depression

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 12, 2018
• Study Start: July 12, 2018
• Primary Completion: December 30, 2019
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)