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

8. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

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

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. juni 2026

Primær færdiggørelse (Anslået)

15. oktober 2026

Studieafslutning (Anslået)

16. oktober 2026

Datoer for studieregistrering

Først indsendt

4. juni 2026

Først indsendt, der opfyldte QC-kriterier

4. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KAD-FR-42

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Periodontale sygdomme

Kliniske forsøg med Non-surgical periodontal treatment

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CROs in Pakistan

Betingelser

Sjældne sygdomme

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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