- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04682275
Effect of Gender on Depression and Periodontal Status
Gender Differences in Periodontal Status of Depressive and Non-Depressive Individuals
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Background: Depression is a multifactorial disease characterized by a variety of symptoms. Individuals with psychiatric disorders seem to be more prone to periodontitis. However periodontal disease and depression can be considered bidirectional risk factors. Periodontal diseases can also be an effect on depression. The purpose of the present study was to evaluate the gender-related differences in the relationship between periodontal diseases and depression in male and female adults.
Material and methods: The study population consisted of 339 subjects. Two groups were formed from these patients: 171 females with periodontal disease (71 subjects with gingivitis, 100 subjects with periodontitis); 168 males with periodontal disease (72 subjects with gingivitis, 96 subjects with periodontitis). Clinical periodontal and psychological measures were performed on females and males group.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Konya, Turquie, 42050
- Necmettin Erbakan University
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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
Exclusion Criteria:
- the presence of any systemic disease other than depression
- smoking and alcohol consumption
- the use of any drugs (antidepressants, anti-inflammatory, and antimicrobial medicaments, and hormonal supplements) that affect the periodontal condition
- have received any periodontal treatment in the last six months
- hormonal condition such as pregnancy or lactation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Female Group
Females with periodontal disease (71 subjects with gingivitis, 100 subjects with periodontitis)
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A questionnaire test (Beck depression Inventory) for depression was performed.
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Aucune intervention: Male Group
males with periodontal disease (72 subjects with gingivitis, 96 subjects with periodontitis)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Depression level
Délai: Baseline
|
The differences in depression level between females and males. Depression level was determined using the Beck Depression Inventory. Beck Depression Inventory (BDI) consists of 21 items. Each of the 21 statements is scored from 0 to 3. The total score allows the classification of depression severity. Scores less than 10 indicates lack of the depression. The scores between10-16 indicate minimum depression, the scores between17-29 indicate moderate depression, scores greater than 30 indicate severe depression. |
Baseline
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Probing pocket depth
Délai: Baseline
|
Probing pocket depth (PPD) was measured for determining the severity of the disease and clinical outcome.
High probing pocket depth shows more severe periodontal disease.
|
Baseline
|
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Gingival index
Délai: Baseline
|
The differences in gingival index scores between females and males.
The gingival index was recorded for determining and classifying gingival status.
The Gingival Index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.
|
Baseline
|
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Plaque index
Délai: Baseline
|
The differences in plaque index scores between females and males.
Plaque index (PI) was recorded for determining and classifying oral hygiene status.
The Plaque Index (GI) scores each site on a 0 to 3 scale with 0 being no plaque in the gingival area and 3 abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
|
Baseline
|
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Bleeding on probing
Délai: Baseline
|
The differences in bleeding on probing scores between females and males.
Bleeding on probing (BOP) has been used to diagnose the presence of periodontal diseases, and it is a reliable indicator of gingival inflammation.
It is useful in providing either positive predictive values or negative predictive values that illustrate disease progression.
A positive predictive value indicates the percentage of people who both exhibit BOP and are correctly diagnosed with progressive periodontal diseases.
A negative predictive value indicates the percentage of people whose BOP test results show no bleeding and no active disease progression.
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Baseline
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Fatma Ucan Yarkac, 1, Necmettin Erbakan University
- Chercheur principal: Ozge Gokturk, 1, Abant Izzet Baysal University
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
- NecmettinCT
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
produit fabriqué et exporté des États-Unis.
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