- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Tokat, Tacchino, 60250
- Gaziosmanpasa University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: 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.
|
Comparatore placebo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Depression level
Lasso di tempo: 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.
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Baseline and after 6 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Body image level
Lasso di tempo: 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
Lasso di tempo: Baseline and after 6 weeks
|
The changes in anxiety level within 6 weeks.
Anxiety level was determined using the Beck Anxiety Inventory.
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Baseline and after 6 weeks
|
Self-esteem level
Lasso di tempo: 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.
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Baseline and after 6 weeks
|
Probing pocket depth
Lasso di tempo: 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.
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Baseline and after 6 weeks
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Clinical attachment level
Lasso di tempo: 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.
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Baseline and after 6 weeks
|
Gingival index
Lasso di tempo: 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.
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Baseline and after 6 weeks
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Plaque index
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Ozge Gokturk, Gaziosmanpasa Universty
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 14-KAEK-218
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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