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The Effect of Vitamin D Supplementation on the Anti-inflammatory Response in Periodontal Diseases

8. juni 2026 oppdatert av: Hatice Yemenoğlu, Recep Tayyip Erdogan University Training and Research Hospital

The Effect of Vitamin D Levels and Supplementation on Anti-inflammatory Response in Periodontal Disease: a Randomized Controlled Clinical Trial

A review of the literature revealed that while there are studies investigating the relationship between vitamin D and periodontal disease, there are no studies investigating the anti-inflammatory effect of vitamin D on periodontal disease. Investigators hypothesized that the increased incidence of periodontal disease in individuals with vitamin D deficiency might be due not only to pro-inflammatory effects but also to impaired bone metabolism and a decrease in the anti- inflammatory mechanism. Investigators aimed to determine this by comparing serum and DOS levels of 1,25-dihydroxyvitamin D (1,25(OH)2D), 25-hydroxyvitamin D (25(OH)D3), Receptor activator nuclear kappa B ligand (RANKL), osteoprotegerin (OPG), Tumor Necrosis Factor Related Apoptosis induced Ligand (TRAIL), Developmental endothelial locus (Del)-1, Lipoxin, Resolvin, interleukin (IL)-10, and transforming growth factor-β (TGF-β).

The study will include 120 individuals who are systemically healthy based on clinical and radiographic examinations and diagnosed with Stage I-II periodontitis, Stage III-IV periodontitis, chronic gingivitis, and periodontally healthy. Periodontal clinical parameters (Probing pocket depth (PPD), Clinical attachment level (CAL), Bleeding on probing (BOP), Plaque index (PI), Gingival index (GI)) will be recorded three times: before treatment, and 6 and 12 weeks after treatment. Gingival crevicular fluid (GCF) and serum samples will be collected from participants at baseline and 12 weeks later for biochemical analysis.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Study groups will be formed according to the 2017 Periodontal Disease Classification. Accordingly:
  • Periodontally healthy; absence of bleeding on probing, erythema, edema, patient symptoms, attachment, and bone loss
  • Gingivitis; patients with an average gingival index ≥0.5 according to Löe and Silness
  • Stage I-II periodontitis; patients with CAL 1-2 or 3-4 mm and a maximum PPD ≤5 mm, showing radiographic horizontal bone loss up to the coronal third of the root (15%-33%), but without tooth loss due to periodontitis
  • Stage III-IV periodontitis; Stage 3 and 4 patients with ≥15 teeth in their mouth, with CAL ≥5 and PPD ≥6 in at least 6 areas, and radiographic bone loss extending to the middle or apical third of the root.

Exclusion Criteria:

  • Individuals who have undergone periodontal treatment in the last 6 months, have systemic diseases (such as diabetes, parathyroid and thyroid-related endocrine diseases) that may affect periodontal status, patients with chronic liver disease, hypoparathyroidism and renal failure, those who have been using medications that may affect periodontal response (aspirin, non-steroidal anti-inflammatory drugs or steroids) for a long time, those who are using additional vitamin D or calcium supplements in the pre-study phase, those who are pregnant or breastfeeding, and those with hypercalcemia and malabsorption syndrome will not be included in the study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Group 1: Stage I-II periodontitis group with vitamin D deficiency
Fremgangsmåte: Non-surgical periodontal treatment
Participants will receive non-surgical periodontal treatment
Kosttilskudd: Vitamin D administration
Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor
Fremgangsmåte: Oral Hygiene Education and Patient Motivation
Participants will receive oral hygiene education
Eksperimentell: Group 2: Stage I-II periodontitis group with vitamin D deficiency
Fremgangsmåte: Non-surgical periodontal treatment
Participants will receive non-surgical periodontal treatment
Fremgangsmåte: Oral Hygiene Education and Patient Motivation
Participants will receive oral hygiene education
Eksperimentell: Group 3: Stage III-IV periodontitis with vitamin D deficiency
Fremgangsmåte: Non-surgical periodontal treatment
Participants will receive non-surgical periodontal treatment
Kosttilskudd: Vitamin D administration
Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor
Fremgangsmåte: Oral Hygiene Education and Patient Motivation
Participants will receive oral hygiene education
Eksperimentell: Group 4: Stage III-IV periodontitis with vitamin D deficiency
Fremgangsmåte: Non-surgical periodontal treatment
Participants will receive non-surgical periodontal treatment
Fremgangsmåte: Oral Hygiene Education and Patient Motivation
Participants will receive oral hygiene education
Eksperimentell: Group 5: Chronic gingivitis with vitamin D deficiency
Fremgangsmåte: Non-surgical periodontal treatment
Participants will receive non-surgical periodontal treatment
Kosttilskudd: Vitamin D administration
Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor
Fremgangsmåte: Oral Hygiene Education and Patient Motivation
Participants will receive oral hygiene education
Eksperimentell: Group 6: Chronic gingivitis with vitamin D deficiency
Fremgangsmåte: Non-surgical periodontal treatment
Participants will receive non-surgical periodontal treatment
Fremgangsmåte: Oral Hygiene Education and Patient Motivation
Participants will receive oral hygiene education
Eksperimentell: Group 7: Periodontally healthy group with sufficient vitamin D levels
Fremgangsmåte: Oral Hygiene Education and Patient Motivation
Participants will receive oral hygiene education
Eksperimentell: Group 8: Periodontally healthy group with vitamin D deficiency
Fremgangsmåte: Oral Hygiene Education and Patient Motivation
Participants will receive oral hygiene education

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Probing pocket depth (PPD)
Tidsramme: These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
Clinical attachment level (CAL)
Tidsramme: These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment

Sekundære resultatmål

Resultatmål
Tidsramme
Collection of gingival crevicular fluid and serum samples
Tidsramme: These parameters were to be recorded 2 times: before treatment and 12 weeks after treatment
These parameters were to be recorded 2 times: before treatment and 12 weeks after treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. juni 2026

Primær fullføring (Antatt)

15. oktober 2026

Studiet fullført (Antatt)

16. oktober 2026

Datoer for studieregistrering

Først innsendt

4. juni 2026

Først innsendt som oppfylte QC-kriteriene

4. juni 2026

Først lagt ut (Faktiske)

9. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KAD-FR-42

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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