- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03190512
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Tokat, Kalkun, 60250
- Gaziosmanpasa University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 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. |
Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.
|
Placebo komparator: 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. |
Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Depression level
Tidsramme: Baseline and after 6 weeks
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The changes in depression level within 6 weeks.
Depression level was determined using the Beck Depression Inventory.
|
Baseline and after 6 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Body image level
Tidsramme: Baseline and after 6 weeks
|
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
Tidsramme: Baseline and after 6 weeks
|
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
Tidsramme: 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.
|
Baseline and after 6 weeks
|
Probing pocket depth
Tidsramme: 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.
|
Baseline and after 6 weeks
|
Clinical attachment level
Tidsramme: 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.
|
Baseline and after 6 weeks
|
Gingival index
Tidsramme: 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.
|
Baseline and after 6 weeks
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Plaque index
Tidsramme: Baseline and after 6 weeks
|
The changes in plaque index after periodontal treatment.
Plaque index was recorded for determining and classifying oral hygiene status.
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Baseline and after 6 weeks
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Bleeding on probing
Tidsramme: 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.
|
Baseline and after 6 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ozge Gokturk, Gaziosmanpasa Universty
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 14-KAEK-218
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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