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RecruitingNCT07636733Updated Jun 10, 2026

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

An interventional study of Non-surgical periodontal treatment and Vitamin D administration in Periodontal Diseases, Gingivitis and Vitamin D Deficiency, sponsored by Recep Tayyip Erdogan University Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Recep Tayyip Erdogan University Training and Research Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Periodontal Diseases
  • Gingivitis
  • Vitamin D Deficiency

Keywords

  • periodontitis
  • gingivitis
  • Vitamin D
  • anti-inflammatory
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Group 1: Stage I-II periodontitis group with vitamin D deficiency

    Procedure: Non-surgical periodontal treatment · Dietary Supplement: Vitamin D administration · Procedure: Oral Hygiene Education and Patient Motivation

  • Experimental
    Group 2: Stage I-II periodontitis group with vitamin D deficiency

    Procedure: Non-surgical periodontal treatment · Procedure: Oral Hygiene Education and Patient Motivation

  • Experimental
    Group 3: Stage III-IV periodontitis with vitamin D deficiency

    Procedure: Non-surgical periodontal treatment · Dietary Supplement: Vitamin D administration · Procedure: Oral Hygiene Education and Patient Motivation

  • Experimental
    Group 4: Stage III-IV periodontitis with vitamin D deficiency

    Procedure: Non-surgical periodontal treatment · Procedure: Oral Hygiene Education and Patient Motivation

  • Experimental
    Group 5: Chronic gingivitis with vitamin D deficiency

    Procedure: Non-surgical periodontal treatment · Dietary Supplement: Vitamin D administration · Procedure: Oral Hygiene Education and Patient Motivation

  • Experimental
    Group 6: Chronic gingivitis with vitamin D deficiency

    Procedure: Non-surgical periodontal treatment · Procedure: Oral Hygiene Education and Patient Motivation

  • Experimental
    Group 7: Periodontally healthy group with sufficient vitamin D levels

    Procedure: Oral Hygiene Education and Patient Motivation

  • Experimental
    Group 8: Periodontally healthy group with vitamin D deficiency

    Procedure: Oral Hygiene Education and Patient Motivation

Interventions

  • ProcedureNon-surgical periodontal treatment

    Participants will receive non-surgical periodontal treatment

  • Dietary supplementVitamin D administration

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

  • ProcedureOral Hygiene Education and Patient Motivation

    Participants will receive oral hygiene education

05

What researchers measure

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

06

Study locations

1 of 1 sites recruiting
  • Recep Tayyip Erdoğan University
    Rize, 53020, Turkey (Türkiye)
    Recruiting
07

Registry details

Key details

Study ID
NCT07636733
Lead sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Responsible party
Hatice Yemenoğlu (Doctor, Recep Tayyip Erdogan University Training and Research Hospital) — Principal investigator
First posted
Jun 9, 2026
Start date
Jun 3, 2026
Primary completion
Oct 15, 2026 (estimated)
Completion
Oct 16, 2026 (estimated)
Last update
Jun 10, 2026

Study contacts

Hatice Yemenoglu
Contact
htcymnglu@hotmail.com
+905052977517

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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