- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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-
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Rize, Kalkon, 53100
- Recep Tayyip Erdogan University
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
chronic periodontitis
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chronic gingivitis
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periodontally healthy
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
periodontal paremeters
Tidsram: December 2015- March 2016
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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).
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December 2015- March 2016
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laboratory analysis
Tidsram: December 2015- March 2016
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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.
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December 2015- March 2016
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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RecepTayyipErdoganUniversity (Annan identifierare: Recepteutrh)
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