- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04209231
Effect of Vitamin D on Periodontal Disease
Principal Investigator
Background. Vitamin D has both direct effects on bone metabolism and an antimicrobial effect on periodontopathogens. It also inhibits inflammatory mediators that contribute to periodontal destruction. The purpose of this study was to evaluate the association between serum 1.25-hydroxyvitamin D (1.25(OH)2D3) and 25(OH)D levels and periodontal inflammation.
Methods. This study included 28 subjects with chronic gingivitis, 29 subjects with chronic periodontitis and 25 periodontally healthy subjects. Blood samples were collected from the participants to determine serum levels of 25(OH)D, 1.25(OH)2D3, tumour necrosis factor α (TNF-α), C-reactive protein (CRP) and interleukin 6 (IL-6). Clinical parameters were recorded. Results were statistically analysed with a Shapiro-Wilk's test, Mann-Whitney U test, Kruskal-Wallis H test, Wilcoxon test and post-hoc multiple comparison test.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The subjects included in the study were selected from among patients who applied to our clinic, for routine periodontal examinations. Individuals who had been using immunosuppressive drugs and antibiotics for the past three months, smokers, individuals who had periodontal treatment within the past six months, and individuals with additional or supplementary vitamin D and systemic diseases were excluded from the study. In addition, since the region's level of sunlight exposure may have an effect on the level of vitamin D, participants were required to live in the region for the last five years.
A total of 82 subjects, including 25 as a periodontally healthy control group, 28 with chronic gingivitis and 29 with chronic periodontitis, were included in the study. Clinical criteria for chronic periodontitis are the formation of plaque and calculus and ≥ 5 milimeter (mm) pocket depth or attachment loss in more than 30% of the teeth. Diagnosis criteria for chronic gingivitis are the formation of plaque and/or calculus in the mouth, bleeding, and no loss of pocket or attachment. The diagnosis criteria for periodontally healthy individuals are having clinically healthy periodontal tissues or minimal periodontal inflammation, with no loss of pocket or attachment.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Rize, Tyrkia, 53100
- Recep Tayyip Erdoğan University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- live in the region for the last five years.
Exclusion Criteria:
- individuals who had been using immunosuppressive drugs and antibiotics for the past three months, smokers, individuals who had periodontal treatment within the past six months, and individuals with additional or supplementary vitamin D and systemic diseases.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
chronic periodontitis
|
|
chronic gingivitis
|
|
periodontally healthy
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
periodontal paremeters
Tidsramme: December 2015- March 2016
|
Attachment loss and pocket depth were measured from the six surfaces of the teeth (buccal, palatal/lingual, mesiobuccal, mesiolingual, distobuccal and distolingual) except for the third molars.
These values were calculated in millimeters (mm).
|
December 2015- March 2016
|
laboratory analysis
Tidsramme: December 2015- March 2016
|
Venous blood samples were collected from the patients on the examination day that were allowed to rest for half an hour and then centrifuged at 4000 rpm for 10 min.
Serum samples were separated into Eppendorf tubes and stored at -20°C until the experiment day.
On the day of biochemical analysis, serum samples were thawed at room temperature and studied according to the manufacturer's instructions.
TNF-a, 1,25(OH)2D3, IL-6 were calculated in pg/mL, 25(OH)D was calculated ng/mL and CRP was calculated mg/dL.
|
December 2015- March 2016
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RecepTayyipErdoganUniversity (Annen identifikator: Recepteutrh)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Periodontale sykdommer
-
G. d'Annunzio UniversityHar ikke rekruttert ennåPeriodontale sykdommer | Intrabony periodontal defekt | Periodontalt tilknytningstap | Lomme, periodontal
-
Krishnadevaraya College of Dental Sciences & HospitalFullførtPeriodontitt | Periodontalt tilknytningstap | Periodontal betennelse | Lomme, periodontalIndia
-
Beni-Suef UniversityRekrutteringPeriodontal helseEgypt
-
Universitat Internacional de CatalunyaFullført
-
University of BeykentFullførtPeriodontale sykdommer | Periodontalt tilknytningstap | Periodontal betennelse | Periodontal sykdom, AVDC trinn 3 | Periodontal sykdom, AVDC stadium 4Tyrkia
-
Postgraduate Institute of Dental Sciences RohtakHar ikke rekruttert ennåIntrabony periodontal defektIndia
-
Cairo UniversityHar ikke rekruttert ennå
-
Istituto Ortopedico GaleazziRekruttering
-
University of Roma La SapienzaFullførtIntrabony periodontal defekt
-
Alexandria UniversityUkjent
Kliniske studier på 1.25(OH)2D3
-
Aristotle University Of ThessalonikiHar ikke rekruttert ennåEndodontisk behandlede tenner | KalsiumhydroksidHellas
-
Deltanoid PharmaceuticalsFullførtNyresvikt, kronisk | Hyperparathyroidisme, sekundærForente stater
-
University of Wisconsin, MadisonUrban League of Greater Madison; African American Council of Churches Madison og andre samarbeidspartnereFullførtTro og fellesskap i handling: Økende bevissthet og håndtering av depresjon i afroamerikanske samfunnDepresjon | Selvledelse | BevissthetForente stater
-
Hospital Universitari de BellvitgeUkjent
-
Nutrition & Sante IberiaAdknoma Health ResearchRekruttering
-
University of Wisconsin, MadisonNational Institute on Minority Health and Health Disparities (NIMHD)Fullført
-
Al-Azhar UniversityFullført
-
Jordan University of Science and TechnologyUkjentDental Pulp Capping | Tannkaries som strekker seg til pulpaJordan
-
Mayo ClinicAndersen FoundationFullført
-
University Hospitals Cleveland Medical CenterEmory UniversityFullført