Periodontal Treatment and Psychology

NCT ID: NCT03190512

Last Updated: 2017-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-04
• Study Completion Date: 2016-09-01

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.

Detailed Description

Background: Depression is a multi-factorial disease characterized by a variety of symptoms. Psychiatric disorders seem to be more prone to periodontitis compared to patients without psychiatric disorders. However periodontal disease and depression can be considered bidirectional risk factors. Periodontal disease can also be an effect on depression. The aim of this randomized controlled clinical study is to determine the effect of non-surgical mechanical periodontal treatment on psychological state.

Material and methods: The study population consisted of 184 depressed patients with non-treated periodontal diseases. Two randomized group is formed from these patients. Immediately periodontal treatment (test group, n = 92) and delayed periodontal treatment (control group, n = 92). Clinical periodontal and psychological measures were performed at baseline and 6th weeks on control and test group.

Conditions

Gum Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Test Group

Psychological measurements were taken from periodontal disease patients before treatment and after 6 weeks.

Intervention: Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and the Psychological questionnaires were filled.

Group Type: ACTIVE_COMPARATOR

Psychological measurements

Intervention Type: OTHER

Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.

Control Group

Psychological measurements were taken from periodontal disease patients at the baseline and after 6 weeks without the periodontal treatment.

Intervention: The Psychological questionnaires were filled.

Group Type: PLACEBO_COMPARATOR

Psychological measurements

Intervention Type: OTHER

Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.

Interventions

Psychological measurements

Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• the presence of periodontal diseases,
• the presence of diagnosed minor depression
• being under maintenance therapy regarding the depression

Exclusion Criteria

• any hormonal condition such as pregnancy or lactation
• received any periodontal treatment within six months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ozge Gokturk

OTHER

Sponsor Role: lead

Responsible Party

Ozge Gokturk

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ozge Gokturk

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa Universty

Locations

Gaziosmanpasa University

Tokat Province, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

14-KAEK-218

Identifier Type: -

Identifier Source: org_study_id