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NCT Number: NCT07636733

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recep Tayyip Erdoğan University

Rize, 53020, Turkey (Türkiye)

Location status: Recruiting

Location contact

Hatice Yemenoglu

CONTACT

[email protected]

+904642220000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-surgical periodontal treatment

Procedure

Participants will receive non-surgical periodontal treatment

Vitamin D administration

Dietary Supplement

Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor

Oral Hygiene Education and Patient Motivation

Procedure

Participants will receive oral hygiene education

Primary outcomes

  1. Probing pocket depth (PPD)

    Time frame: These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment

  2. Clinical attachment level (CAL)

    Time frame: These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment

Secondary outcomes

  1. Collection of gingival crevicular fluid and serum samples

    Time frame: These parameters were to be recorded 2 times: before treatment and 12 weeks after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Hatice Yemenoglu

CONTACT

[email protected]

+905052977517

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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