- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Tokat, Turquie, 60250
- Gaziosmanpasa University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: 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.
|
Comparateur 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Depression level
Délai: Baseline and after 6 weeks
|
The changes in depression level within 6 weeks.
Depression level was determined using the Beck Depression Inventory.
|
Baseline and after 6 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Body image level
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Plaque index
Délai: Baseline and after 6 weeks
|
The changes in plaque index after periodontal treatment.
Plaque index was recorded for determining and classifying oral hygiene status.
|
Baseline and after 6 weeks
|
Bleeding on probing
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ozge Gokturk, Gaziosmanpasa Universty
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 14-KAEK-218
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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