Periodontal DiseasesNCT07636733
The Effect of Vitamin D Supplementation on the Anti-inflammatory Response in Periodontal Diseases
A study testing Non-surgical periodontal treatment, Vitamin D administration and Oral Hygiene Education and Patient Motivation in people with Periodontal Diseases and Gingivitis, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Gingivitis, Vitamin D Deficiency
- What is being tested?
- Non-surgical periodontal treatment, Vitamin D administration and Oral Hygiene Education and Patient Motivation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2026to 16 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Recep Tayyip Erdoğan University
Rize, 53020
Hatice Yemenoglu, +904642220000, htcymnglu@hotmail.com
About this study
Official title: 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.
- Conditions
- Periodontal Diseases, Gingivitis, Vitamin D Deficiency
- Being tested
- Non-surgical periodontal treatment, Vitamin D administration, Oral Hygiene Education and Patient Motivation
- Keywords
- periodontitis, gingivitis, Vitamin D, anti-inflammatory
- Medical subject headings
- Periodontal Diseases, Gingivitis, Vitamin D Deficiency, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentProcedure or surgery
Participants will receive non-surgical periodontal treatment
Vitamin D administrationDietary supplement
Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor
Oral Hygiene Education and Patient MotivationProcedure or surgery
Participants will receive oral hygiene education
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Stage I-II periodontitis group with vitamin D deficiency | Experimental | Not described Receives: 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 | Not described Receives: Procedure: Non-surgical periodontal treatment; Procedure: Oral Hygiene Education and Patient Motivation |
| Group 3: Stage III-IV periodontitis with vitamin D deficiency | Experimental | Not described Receives: 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 | Not described Receives: Procedure: Non-surgical periodontal treatment; Procedure: Oral Hygiene Education and Patient Motivation |
| Group 5: Chronic gingivitis with vitamin D deficiency | Experimental | Not described Receives: 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 | Not described Receives: Procedure: Non-surgical periodontal treatment; Procedure: Oral Hygiene Education and Patient Motivation |
| Group 7: Periodontally healthy group with sufficient vitamin D levels | Experimental | Not described Receives: Procedure: Oral Hygiene Education and Patient Motivation |
| Group 8: Periodontally healthy group with vitamin D deficiency | Experimental | Not described Receives: Procedure: Oral Hygiene Education and Patient Motivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth (PPD)
Measured: These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
Clinical attachment level (CAL)
Measured: 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
Measured: These parameters were to be recorded 2 times: before treatment and 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start3 Jun 2026
- Primary completion15 Oct 2026 (estimated)
- Study completion16 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Yemenoğlu, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636733
- Sponsor's protocol ID
- KAD-FR-42
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Levels and Supplementation on Anti-inflammatory Response in Periodontal Disease: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07636733
- Acronym / sponsor ID
- KAD-FR-42
- Conditions
- Periodontal Diseases, Gingivitis, Vitamin D Deficiency
- Keywords
- periodontitis, gingivitis, Vitamin D, anti-inflammatory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 16 Oct 2026 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-surgical periodontal treatmentParticipants will receive non-surgical periodontal treatment | Procedure or surgery | 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 |
| Vitamin D administrationParticipants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor | Dietary supplement | 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 |
| Oral Hygiene Education and Patient MotivationParticipants will receive oral hygiene education | Procedure or surgery | 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 |
Primary outcome
Probing pocket depth (PPD)
Time frame: 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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal treatment, Vitamin D administration and Oral Hygiene Education and Patient Motivation in people with Periodontal Diseases and Gingivitis, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatice Yemenoglu (+905052977517, htcymnglu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth (PPD) (time frame: These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.