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Completed

NCT Number: NCT03190512

Periodontal Treatment and Psychology

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.

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Key information

Conditions

Gum Disease Behavior Behavioral Symptoms Depression Gingival Diseases Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpasa University

Tokat Province, 60250, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychological measurements

Other

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

Primary outcomes

  1. Depression level

    Time frame: Baseline and after 6 weeks

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

Secondary outcomes

  1. Body image level

    Time frame: Baseline and after 6 weeks

    The changes in body image level within 6 weeks. Body image level was determined using the Body Cathexis Scale.

  2. Anxiety level

    Time frame: Baseline and after 6 weeks

    The changes in anxiety level within 6 weeks. Anxiety level was determined using the Beck Anxiety Inventory.

  3. Self-esteem level

    Time frame: Baseline and after 6 weeks

    The changes in self-esteem level within 6 weeks. Self-esteem level was determined using the Rosenberg Self-Esteem Scale.

  4. Probing pocket depth

    Time frame: Baseline and after 6 weeks

    The changes in probing pocket depth after periodontal treatment.Probing pocket depth was measured for determining severity of disease and clinic outcome.

  5. Clinical attachment level

    Time frame: Baseline and after 6 weeks

    The changes in clinical attachment level after periodontal treatment. Clinical attachment level was measured for determining severity of disease and clinic outcome.

  6. Gingival index

    Time frame: Baseline and after 6 weeks

    The changes in gingival index level after periodontal treatment. Clinical attachment level was measured for determining severity of disease and clinic outcome.

  7. Plaque index

    Time frame: Baseline and after 6 weeks

    The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.

  8. Bleeding on probing

    Time frame: Baseline and after 6 weeks

    The changes in bleeding on probing after periodontal treatment. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.

Sponsors and collaborators

Lead sponsor

Ozge Gokturk

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 16, 2017
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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