Chronic PeriodontitisNCT03553095
Comparing Inflammatory Markers in Patients With and Without Depression With Chronic Periodontitis
A study testing Periodontal Surgery in people with Chronic Periodontitis and Depression, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will evaluate whether use of antidepressants can reduce gingival inflammation in patients with periodontal (gum) disease. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Depression
- What is being tested?
- Periodontal Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2018to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Alabama at Birmingham, School of Dentistry
Birmingham, Alabama, 35294-0007
About this study
This study will evaluate whether use of antidepressants can reduce gingival inflammation in patients with periodontal (gum) disease.
Read the 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.
- Conditions
- Chronic Periodontitis, Depression
- Being tested
- Periodontal Surgery
- Medical subject headings
- Chronic Periodontitis, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Periodontitis and Depression Medications | Active comparator | Patients with clinically diagnosed depression taking (SSRIs, NDRIs, SNRIs, tricyclic antidepressants) and with chronic periodontitis Receives: Procedure: Periodontal Surgery |
| Chronic Periodontitis without Depression Medications | Active comparator | Patients with clinically diagnosed depression not taking any antidepressants (SSRIs NDRIs, SNRIs and Tricyclic antidepressants) and with chronic periodontitis Receives: Procedure: Periodontal Surgery |
| Chronic Periodontitis | Active comparator | Patients without depression, not taking any antidepressants and with chronic periodontitis Receives: Procedure: Periodontal Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival crevicular fluid (GCF)
Measuring oral inflammatory markers in Gingival crevicular fluid (GCF) in patient with chronic periodontitis.
Measured: baseline to 1 week
Secondary outcomes (1)
Plaque
Analyze the type of bacteria that is present in patient with chronic periodontitis.
Measured: baseline to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start12 Jul 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maninder Kaur, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553095
- Sponsor's protocol ID
- IRB-300000426
- Other IDs
- UAB-Perio
- Status last verified
- Dec 2025
- First submitted
- 29 May 2018
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Inflammatory Markers in Patients With and Without Depression With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT03553095
- Acronym / sponsor ID
- IRB-300000426
- Conditions
- Chronic Periodontitis, Depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic Periodontitis and Depression Medications | Active comparator | Procedure: Periodontal SurgeryPatients with clinically diagnosed depression taking (SSRIs, NDRIs, SNRIs, tricyclic antidepressants) and with chronic periodontitis |
| Chronic Periodontitis without Depression Medications | Active comparator | Procedure: Periodontal SurgeryPatients with clinically diagnosed depression not taking any antidepressants (SSRIs NDRIs, SNRIs and Tricyclic antidepressants) and with chronic periodontitis |
| Chronic Periodontitis | Active comparator | Procedure: Periodontal SurgeryPatients without depression, not taking any antidepressants and with chronic periodontitis |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal SurgerySamples 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. | Procedure or surgery | Chronic Periodontitis, Chronic Periodontitis and Depression Medications, Chronic Periodontitis without Depression Medications |
Primary outcome
Gingival crevicular fluid (GCF)
Time frame: baseline to 1 week
Measuring oral inflammatory markers in Gingival crevicular fluid (GCF) in patient with chronic periodontitis.
1 secondary outcome
Plaque
Time frame: baseline to 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal Surgery in people with Chronic Periodontitis and Depression, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival crevicular fluid (GCF) (time frame: baseline to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.