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Periodontal Treatment and Psychology

Primary Purpose

Gum Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Psychological measurements
Sponsored by
Ozge Gokturk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gum Disease focused on measuring Periodontal disease, depression, body image, self-esteem

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gaziosmanpasa University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Test Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Depression level
The changes in depression level within 6 weeks. Depression level was determined using the Beck Depression Inventory.

Secondary Outcome Measures

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

Full Information

First Posted
June 12, 2017
Last Updated
June 15, 2017
Sponsor
Ozge Gokturk
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1. Study Identification

Unique Protocol Identification Number
NCT03190512
Brief Title
Periodontal Treatment and Psychology
Official Title
The Effect of Periodontal Treatment on Depression, Body Image, Self-Esteem and Anxiety in Depressed Patients: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 4, 2015 (Actual)
Primary Completion Date
March 31, 2016 (Actual)
Study Completion Date
September 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ozge Gokturk

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gum Disease
Keywords
Periodontal disease, depression, body image, self-esteem

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Psychological measurements
Intervention Description
Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.
Primary Outcome Measure Information:
Title
Depression level
Description
The changes in depression level within 6 weeks. Depression level was determined using the Beck Depression Inventory.
Time Frame
Baseline and after 6 weeks
Secondary Outcome Measure Information:
Title
Body image level
Description
The changes in body image level within 6 weeks. Body image level was determined using the Body Cathexis Scale.
Time Frame
Baseline and after 6 weeks
Title
Anxiety level
Description
The changes in anxiety level within 6 weeks. Anxiety level was determined using the Beck Anxiety Inventory.
Time Frame
Baseline and after 6 weeks
Title
Self-esteem level
Description
The changes in self-esteem level within 6 weeks. Self-esteem level was determined using the Rosenberg Self-Esteem Scale.
Time Frame
Baseline and after 6 weeks
Title
Probing pocket depth
Description
The changes in probing pocket depth after periodontal treatment.Probing pocket depth was measured for determining severity of disease and clinic outcome.
Time Frame
Baseline and after 6 weeks
Title
Clinical attachment level
Description
The changes in clinical attachment level after periodontal treatment. Clinical attachment level was measured for determining severity of disease and clinic outcome.
Time Frame
Baseline and after 6 weeks
Title
Gingival index
Description
The changes in gingival index level after periodontal treatment. Clinical attachment level was measured for determining severity of disease and clinic outcome.
Time Frame
Baseline and after 6 weeks
Title
Plaque index
Description
The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.
Time Frame
Baseline and after 6 weeks
Title
Bleeding on probing
Description
The changes in bleeding on probing after periodontal treatment. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.
Time Frame
Baseline and after 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozge Gokturk
Organizational Affiliation
Gaziosmanpasa Universty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziosmanpasa University
City
Tokat
ZIP/Postal Code
60250
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Periodontal Treatment and Psychology

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