- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT04682275
Effect of Gender on Depression and Periodontal Status
Gender Differences in Periodontal Status of Depressive and Non-Depressive Individuals
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Konya, Kalkoen, 42050
- Necmettin Erbakan University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: Female Group
Females with periodontal disease (71 subjects with gingivitis, 100 subjects with periodontitis)
|
A questionnaire test (Beck depression Inventory) for depression was performed.
|
|
Geen tussenkomst: Male Group
males with periodontal disease (72 subjects with gingivitis, 96 subjects with periodontitis)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Depression level
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Probing pocket depth
Tijdsspanne: 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
|
|
Gingival index
Tijdsspanne: 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
|
|
Plaque index
Tijdsspanne: 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
|
|
Bleeding on probing
Tijdsspanne: 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.
|
Baseline
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Fatma Ucan Yarkac, 1, Necmettin Erbakan University
- Hoofdonderzoeker: Ozge Gokturk, 1, Abant Izzet Baysal University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NecmettinCT
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .