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NCT Number: NCT04682275

Effect of Gender on Depression and Periodontal Status

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.

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Key information

Conditions

Periodontal Diseases Behavior Behavioral Symptoms Coitus Depression Gender Gingival Diseases Mouth Diseases Sexual Behavior Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University

Konya, 42050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychological measurements

Other

A questionnaire test (Beck depression Inventory) for depression was performed.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Dec 23, 2020
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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