Effect of Gender on Depression and Periodontal Status

Sponsor

Necmettin Erbakan University (Other)

Overall Status

Completed

CT.gov ID

NCT04682275

Collaborator

(none)

339

Enrollment

Location

Arms

Actual Duration (Months)

28.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Diseases Depression Gender Gingival Diseases	Other: Psychological measurements	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

339 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 12, 2017

Actual Primary Completion Date :

Mar 12, 2017

Actual Study Completion Date :

Feb 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Female Group Females with periodontal disease (71 subjects with gingivitis, 100 subjects with periodontitis)	Other: Psychological measurements 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)

Arm

Intervention/Treatment

Other: Female Group

Females with periodontal disease (71 subjects with gingivitis, 100 subjects with periodontitis)

Other: Psychological measurements

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)

Outcome Measures

Primary Outcome Measures

Depression level [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 Outcome Measures

Probing pocket depth [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.
Gingival index [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.
Plaque index [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.
Bleeding on probing [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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