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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03553095
Other study ID # IRB-300000426
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 12, 2018
Est. completion date August 30, 2019

Study information

Verified date July 2018
Source University of Alabama at Birmingham
Contact Maninder Kaur, BDS, MS
Phone 2059344506
Email maninder@uab.edu
Is FDA regulated No
Health authority
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 Recruiting
Enrollment 90
Est. completion date August 30, 2019
Est. primary completion date July 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)

Study Design


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
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