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
1 other identifier
interventional
184
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2015
1 active site
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
May 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 12, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedJune 16, 2017
June 1, 2017
11 months
June 12, 2017
June 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Body image level
Baseline and after 6 weeks
Anxiety level
Baseline and after 6 weeks
Self-esteem level
Baseline and after 6 weeks
Probing pocket depth
Baseline and after 6 weeks
Clinical attachment level
Baseline and after 6 weeks
- +3 more secondary outcomes
Study Arms (2)
Test Group
ACTIVE COMPARATORPsychological 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.
Control Group
PLACEBO COMPARATORPsychological measurements were taken from periodontal disease patients at the baseline and after 6 weeks without the periodontal treatment. Intervention: The Psychological questionnaires were filled.
Interventions
Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.
Eligibility Criteria
You may qualify if:
- the presence of periodontal diseases,
- the presence of diagnosed minor depression
- being under maintenance therapy regarding the depression
You may not qualify if:
- any hormonal condition such as pregnancy or lactation
- received any periodontal treatment within six months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ozge Gokturklead
Study Sites (1)
Gaziosmanpasa University
Tokat Province, 60250, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ozge Gokturk
Gaziosmanpasa Universty
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 12, 2017
First Posted
June 16, 2017
Study Start
May 4, 2015
Primary Completion
March 31, 2016
Study Completion
September 1, 2016
Last Updated
June 16, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share