Periodontal Treatment and Psychology

Not Applicable

Completed

• Conditions: Gum Disease
• Interventions: Other: Psychological measurements

• Registration Number: NCT03190512
• Lead Sponsor: Ozge Gokturk

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.

Study Timeline

• Study Start: 2015-05-04
• Primary Completion: 2016-03-31
• Study Completion: 2016-09-01
• Status Verified: 2017-06
• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-15
• Last Update Submitted: 2017-06-15
• Study First Posted: 2017-06-16
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Psychological measurements	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.
Test Group	Psychological measurements	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.

Primary Outcome Measures

Name	Time	Method
Depression level	Baseline and after 6 weeks	The changes in depression level within 6 weeks. Depression level was determined using the Beck Depression Inventory.

Secondary Outcome Measures

Name	Time	Method
Body image level	Baseline and after 6 weeks	The changes in body image level within 6 weeks. Body image level was determined using the Body Cathexis Scale.
Probing pocket depth	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.
Gingival index	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.
Plaque index	Baseline and after 6 weeks	The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.
Bleeding on probing	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.
Anxiety level	Baseline and after 6 weeks	The changes in anxiety level within 6 weeks. Anxiety level was determined using the Beck Anxiety Inventory.
Self-esteem level	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.
Clinical attachment level	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.

Trial Locations

Locations (1)

Gaziosmanpasa University; 🇹🇷 Tokat, Turkey