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

NCT07636733 | Recruiting

• 1 other identifier: KAD-FR-42
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontal Diseases; Gingivitis; Vitamin D Deficiency

Keywords

periodontitis; gingivitis; Vitamin D; anti-inflammatory

Outcome Measures

Primary Outcomes (2)

• Probing pocket depth (PPD)

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

• Clinical attachment level (CAL)

  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

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

Study Arms (8)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Group 5: Chronic gingivitis with vitamin D deficiency

EXPERIMENTAL

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

Group 6: Chronic gingivitis with vitamin D deficiency

EXPERIMENTAL

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

Group 7: Periodontally healthy group with sufficient vitamin D levels

EXPERIMENTAL

Procedure: Oral Hygiene Education and Patient Motivation

Group 8: Periodontally healthy group with vitamin D deficiency

EXPERIMENTAL

Procedure: Oral Hygiene Education and Patient Motivation

Interventions

Vitamin D administration DIETARY_SUPPLEMENT

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

Group 1: Stage I-II periodontitis group with vitamin D deficiency; Group 3: Stage III-IV periodontitis with vitamin D deficiency; Group 5: Chronic gingivitis with vitamin D deficiency

Non-surgical periodontal treatment PROCEDURE

Participants will receive non-surgical periodontal treatment

Group 1: Stage I-II periodontitis group with vitamin D deficiency; Group 2: Stage I-II periodontitis group with vitamin D deficiency; Group 3: Stage III-IV periodontitis with vitamin D deficiency; Group 4: Stage III-IV periodontitis with vitamin D deficiency; Group 5: Chronic gingivitis with vitamin D deficiency; Group 6: Chronic gingivitis with vitamin D deficiency

Oral Hygiene Education and Patient Motivation PROCEDURE

Participants will receive oral hygiene education

Group 1: Stage I-II periodontitis group with vitamin D deficiency; Group 2: Stage I-II periodontitis group with vitamin D deficiency; Group 3: Stage III-IV periodontitis with vitamin D deficiency; Group 4: Stage III-IV periodontitis with vitamin D deficiency; Group 5: Chronic gingivitis with vitamin D deficiency; Group 6: Chronic gingivitis with vitamin D deficiency; Group 7: Periodontally healthy group with sufficient vitamin D levels; Group 8: Periodontally healthy group with vitamin D deficiency

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead

Study Sites (1)

Recep Tayyip Erdoğan University

Rize, 53020, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Gingivitis; Vitamin D Deficiency; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Hatice Yemenoglu

CONTACT

+905052977517; htcymnglu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start: June 3, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 16, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

TU (1)