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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03553095
• Other study ID #: IRB-300000426
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 12, 2018
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 92
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Periodontitis
• Depression
• Depressive Disorder
• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
United States	Unversity of Alabama at Birmingham, School of Dentistry	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Soft tissue	Analyze the immune cells in patient with chronic periodontitis.	baseline to 1 week
Other	Blood Serum	Analyze the systemic inflammatory markers in patient with chronic periodontitis.	baseline to 1 week
Other	Patient Health Questionnaire 8 (PHQ8)	Measure depression status in patient with chronic periodontitis.	baseline to 1 week
Primary	Gingival crevicular fluid (GCF)	Measuring oral inflammatory markers in Gingival crevicular fluid (GCF) in patient with chronic periodontitis.	baseline to 1 week
Secondary	Plaque	Analyze the type of bacteria that is present in patient with chronic periodontitis.	baseline to 1 week