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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03553095

Collaborator

(none)

Enrollment

Location

Arms

53.6

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Periodontitis Depression	Procedure: Periodontal Surgery	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 12, 2018

Actual Primary Completion Date :

Dec 30, 2019

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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.

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

Active Comparator: Chronic Periodontitis

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

Procedure: Periodontal Surgery

Outcome Measures

Primary Outcome Measures

Gingival crevicular fluid (GCF) [baseline to 1 week]
Measuring oral inflammatory markers in Gingival crevicular fluid (GCF) in patient with chronic periodontitis.

Secondary Outcome Measures

Plaque [baseline to 1 week]
Analyze the type of bacteria that is present in patient with chronic periodontitis.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unversity of Alabama at Birmingham, School of Dentistry	Birmingham	Alabama	United States	35294-0007

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maninder Kaur, Principal Investigator, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT03553095

Other Study ID Numbers:

IRB-300000426

First Posted:

Jun 12, 2018

Last Update Posted:

Mar 11, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Periodontitis

Chronic Periodontitis

Depression

Depressive Disorder

Study Results

No Results Posted as of Mar 11, 2022