Effect of Gender on Depression and Periodontal Status

December 22, 2020 updated by: Fatma Uçan Yarkaç, Necmettin Erbakan University

Gender Differences in Periodontal Status of Depressive and Non-Depressive Individuals

There is a relationship between depression and periodontal disease. This relationship may be double-sided. A psychological state such as anxiety, depression, body image, and self-esteem may be affected from the symptoms of periodontal disease.

Study Overview

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

Interventional

Enrollment (Actual)

339

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Konya, Turkey, 42050
        • Necmettin Erbakan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
A questionnaire test (Beck depression Inventory) for depression was performed.
No Intervention: Male Group
males with periodontal disease (72 subjects with gingivitis, 96 subjects with periodontitis)

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
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.
Baseline
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fatma Ucan Yarkac, 1, Necmettin Erbakan University
  • Principal Investigator: Ozge Gokturk, 1, Abant Izzet Baysal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2017

Primary Completion (Actual)

March 12, 2017

Study Completion (Actual)

February 12, 2018

Study Registration Dates

First Submitted

December 6, 2020

First Submitted That Met QC Criteria

December 20, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 22, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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