- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04682275
Effect of Gender on Depression and Periodontal Status
Gender Differences in Periodontal Status of Depressive and Non-Depressive Individuals
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Depression is a multifactorial disease characterized by a variety of symptoms. Individuals with psychiatric disorders seem to be more prone to periodontitis. However periodontal disease and depression can be considered bidirectional risk factors. Periodontal diseases can also be an effect on depression. The purpose of the present study was to evaluate the gender-related differences in the relationship between periodontal diseases and depression in male and female adults.
Material and methods: The study population consisted of 339 subjects. Two groups were formed from these patients: 171 females with periodontal disease (71 subjects with gingivitis, 100 subjects with periodontitis); 168 males with periodontal disease (72 subjects with gingivitis, 96 subjects with periodontitis). Clinical periodontal and psychological measures were performed on females and males group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Konya, Turkey, 42050
- Necmettin Erbakan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- the presence of periodontal diseases
Exclusion Criteria:
- the presence of any systemic disease other than depression
- smoking and alcohol consumption
- the use of any drugs (antidepressants, anti-inflammatory, and antimicrobial medicaments, and hormonal supplements) that affect the periodontal condition
- have received any periodontal treatment in the last six months
- hormonal condition such as pregnancy or lactation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Female Group
Females with periodontal disease (71 subjects with gingivitis, 100 subjects with periodontitis)
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A questionnaire test (Beck depression Inventory) for depression was performed.
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No Intervention: Male Group
males with periodontal disease (72 subjects with gingivitis, 96 subjects with periodontitis)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression level
Time Frame: Baseline
|
The differences in depression level between females and males. Depression level was determined using the Beck Depression Inventory. Beck Depression Inventory (BDI) consists of 21 items. Each of the 21 statements is scored from 0 to 3. The total score allows the classification of depression severity. Scores less than 10 indicates lack of the depression. The scores between10-16 indicate minimum depression, the scores between17-29 indicate moderate depression, scores greater than 30 indicate severe depression. |
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probing pocket depth
Time Frame: Baseline
|
Probing pocket depth (PPD) was measured for determining the severity of the disease and clinical outcome.
High probing pocket depth shows more severe periodontal disease.
|
Baseline
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Gingival index
Time Frame: Baseline
|
The differences in gingival index scores between females and males.
The gingival index was recorded for determining and classifying gingival status.
The Gingival Index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.
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Baseline
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Plaque index
Time Frame: Baseline
|
The differences in plaque index scores between females and males.
Plaque index (PI) was recorded for determining and classifying oral hygiene status.
The Plaque Index (GI) scores each site on a 0 to 3 scale with 0 being no plaque in the gingival area and 3 abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
|
Baseline
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Bleeding on probing
Time Frame: Baseline
|
The differences in bleeding on probing scores between females and males.
Bleeding on probing (BOP) has been used to diagnose the presence of periodontal diseases, and it is a reliable indicator of gingival inflammation.
It is useful in providing either positive predictive values or negative predictive values that illustrate disease progression.
A positive predictive value indicates the percentage of people who both exhibit BOP and are correctly diagnosed with progressive periodontal diseases.
A negative predictive value indicates the percentage of people whose BOP test results show no bleeding and no active disease progression.
|
Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fatma Ucan Yarkac, 1, Necmettin Erbakan University
- Principal Investigator: Ozge Gokturk, 1, Abant Izzet Baysal University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NecmettinCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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