NCT04682275

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
339

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2017

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

28 days

First QC Date

December 6, 2020

Last Update Submit

December 22, 2020

Conditions

Keywords

periodontal diseasesdepressiongendergingival diseases

Outcome Measures

Primary Outcomes (1)

  • Depression level

    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 Outcomes (4)

  • Probing pocket depth

    Baseline

  • Gingival index

    Baseline

  • Plaque index

    Baseline

  • Bleeding on probing

    Baseline

Study Arms (2)

Female Group

OTHER

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

Other: Psychological measurements

Male Group

NO INTERVENTION

males with periodontal disease (72 subjects with gingivitis, 96 subjects with periodontitis)

Interventions

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

Female Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the presence of periodontal diseases

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, 42050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal DiseasesDepressionCoitusGingival Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesBehavioral SymptomsBehaviorSexual Behavior

Study Officials

  • Fatma Ucan Yarkac, 1

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR
  • Ozge Gokturk, 1

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2020

First Posted

December 23, 2020

Study Start

February 12, 2017

Primary Completion

March 12, 2017

Study Completion

February 12, 2018

Last Updated

December 24, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations