Periodontal Treatment and Psychology

The Effect of Periodontal Treatment on Depression, Body Image, Self-Esteem and Anxiety in Depressed Patients: A Randomized Controlled Clinical Trial

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

• Status: Completed
• Conditions: Gum Disease
• Intervention / Treatment: Other: Psychological measurements

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.

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Tokat, Turkey, 60250
    • Gaziosmanpasa University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Psychological measurements; Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.
Placebo Comparator: 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.	Other: Psychological measurements; Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression level	The changes in depression level within 6 weeks. Depression level was determined using the Beck Depression Inventory.	Baseline and after 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body image level	The changes in body image level within 6 weeks. Body image level was determined using the Body Cathexis Scale.	Baseline and after 6 weeks
Anxiety level	The changes in anxiety level within 6 weeks. Anxiety level was determined using the Beck Anxiety Inventory.	Baseline and after 6 weeks
Self-esteem level	The changes in self-esteem level within 6 weeks. Self-esteem level was determined using the Rosenberg Self-Esteem Scale.	Baseline and after 6 weeks
Probing pocket depth	The changes in probing pocket depth after periodontal treatment.Probing pocket depth was measured for determining severity of disease and clinic outcome.	Baseline and after 6 weeks
Clinical attachment level	The changes in clinical attachment level after periodontal treatment. Clinical attachment level was measured for determining severity of disease and clinic outcome.	Baseline and after 6 weeks
Gingival index	The changes in gingival index level after periodontal treatment. Clinical attachment level was measured for determining severity of disease and clinic outcome.	Baseline and after 6 weeks
Plaque index	The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.	Baseline and after 6 weeks
Bleeding on probing	The changes in bleeding on probing after periodontal treatment. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.	Baseline and after 6 weeks

Collaborators and Investigators

• Sponsor: Ozge Gokturk
• Investigators: Principal Investigator: Ozge Gokturk, Gaziosmanpasa Universty

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2015
• Primary Completion (Actual): March 31, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: depression; self-esteem; Periodontal disease; body image
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases; Gingival Diseases
• Other Study ID Numbers: 14-KAEK-218

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