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

Primary Purpose

Chronic Periodontitis, Depression

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Periodontal Surgery
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Periodontitis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Unversity of Alabama at Birmingham, School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Chronic Periodontitis and Depression Medications

Chronic Periodontitis without Depression Medications

Chronic Periodontitis

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Plaque
Analyze the type of bacteria that is present in patient with chronic periodontitis.

Full Information

First Posted
May 29, 2018
Last Updated
January 5, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03553095
Brief Title
Comparing Inflammatory Markers in Patients With and Without Depression With Chronic Periodontitis
Official Title
Comparing Inflammatory Markers in Patients With and Without Depression With Chronic Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Depression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic Periodontitis and Depression Medications
Arm Type
Active Comparator
Arm Description
Patients with clinically diagnosed depression taking (SSRIs, NDRIs, SNRIs, tricyclic antidepressants) and with chronic periodontitis
Arm Title
Chronic Periodontitis without Depression Medications
Arm Type
Active Comparator
Arm Description
Patients with clinically diagnosed depression not taking any antidepressants (SSRIs NDRIs, SNRIs and Tricyclic antidepressants) and with chronic periodontitis
Arm Title
Chronic Periodontitis
Arm Type
Active Comparator
Arm Description
Patients without depression, not taking any antidepressants and with chronic periodontitis
Intervention Type
Procedure
Intervention Name(s)
Periodontal Surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gingival crevicular fluid (GCF)
Description
Measuring oral inflammatory markers in Gingival crevicular fluid (GCF) in patient with chronic periodontitis.
Time Frame
baseline to 1 week
Secondary Outcome Measure Information:
Title
Plaque
Description
Analyze the type of bacteria that is present in patient with chronic periodontitis.
Time Frame
baseline to 1 week
Other Pre-specified Outcome Measures:
Title
Soft tissue
Description
Analyze the immune cells in patient with chronic periodontitis.
Time Frame
baseline to 1 week
Title
Blood Serum
Description
Analyze the systemic inflammatory markers in patient with chronic periodontitis.
Time Frame
baseline to 1 week
Title
Patient Health Questionnaire 8 (PHQ8)
Description
Measure depression status in patient with chronic periodontitis.
Time Frame
baseline to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Unversity of Alabama at Birmingham, School of Dentistry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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