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

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ClinicalTrials.gov Identifier: NCT03553095
Recruitment Status : Active, not recruiting
First Posted : June 12, 2018
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Maninder Kaur, University of Alabama at Birmingham

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : July 12, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Gingival crevicular fluid (GCF) [ Time Frame: baseline to 1 week ]
    Measuring oral inflammatory markers in Gingival crevicular fluid (GCF) in patient with chronic periodontitis.


Secondary Outcome Measures :
  1. Plaque [ Time Frame: baseline to 1 week ]
    Analyze the type of bacteria that is present in patient with chronic periodontitis.


Other Outcome Measures:
  1. Soft tissue [ Time Frame: baseline to 1 week ]
    Analyze the immune cells in patient with chronic periodontitis.

  2. Blood Serum [ Time Frame: baseline to 1 week ]
    Analyze the systemic inflammatory markers in patient with chronic periodontitis.

  3. Patient Health Questionnaire 8 (PHQ8) [ Time Frame: baseline to 1 week ]
    Measure depression status in patient with chronic periodontitis.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553095


Locations
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United States, Alabama
Unversity of Alabama at Birmingham, School of Dentistry
Birmingham, Alabama, United States, 35294-0007
Sponsors and Collaborators
University of Alabama at Birmingham

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Responsible Party: Maninder Kaur, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03553095     History of Changes
Other Study ID Numbers: IRB-300000426
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chronic Periodontitis
Depression
Depressive Disorder
Periodontitis
Behavioral Symptoms
Mood Disorders
Mental Disorders
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs