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

June 4, 2026 updated by: 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. We 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. We 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Stage I-II periodontitis group with vitamin D deficiency
Procedure: Non-surgical periodontal treatment
Participants will receive non-surgical periodontal treatment
Dietary supplement: 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
Experimental: 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
Experimental: Group 3: Stage III-IV periodontitis with vitamin D deficiency
Procedure: Non-surgical periodontal treatment
Participants will receive non-surgical periodontal treatment
Dietary supplement: 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
Experimental: 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
Experimental: Group 5: Chronic gingivitis with vitamin D deficiency
Procedure: Non-surgical periodontal treatment
Participants will receive non-surgical periodontal treatment
Dietary supplement: 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
Experimental: 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
Experimental: Group 7: Periodontally healthy group with sufficient vitamin D levels
Procedure: Oral Hygiene Education and Patient Motivation
Participants will receive oral hygiene education
Experimental: Group 8: Periodontally healthy group with vitamin D deficiency
Procedure: Oral Hygiene Education and Patient Motivation
Participants will receive oral hygiene education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Probing pocket depth (PPD)
Time Frame: 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)
Time Frame: 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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 16, 2026

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAD-FR-42

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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