Vitamin D DeficiencyNCT06452251
Vitamin-D Insufficiency and Implants
An observational study of Vitamin D Deficiency and Osseointegration Failure of Dental Implant, run by Vesile Elif Toy at 1 site in Turkey (Türkiye).
Trial summary
Vitamin D is important for bone health, immune function, and inflammation, along with dental implant success. The study aimed to assess bone markers and cytokine levels in patients with and without vitamin D insufficiency to better understand the effects of vitamin D levels on dental implant integration. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Osseointegration Failure of Dental Implant, Peri-Implantitis
- What is being tested?
- OPG, OC, RANKL, IL-10, IL-1β, Ca, TNF-α and Caspase-1 ELISA, Resonance Frequency Analysis and Periodontal clinical examination
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: For the Vitamin D sufficient group (Group S) >20 ng/ml threshold was determined as vitamin D sufficient, and Vitamin D insufficient group (Groups IN-S) 12-20 ng/mol was determined as insufficient. Vitamin D deficient patients (<12 ng/ml), already using vitamin D supplements, were not included in the current study.
Who may be able to join
- Being volunteer to participate in the study, For the Vitamin D sufficient group (Group S) having a vitamin D level >20 ng/ml; and 12-20 ng/ml for Vitamin D insufficient group (Groups IN-S).
- Having sufficient bone height and width at the edentulous areas, Not having a systemic disease that may adversely affect osseointegration, Not smoking Maintaining oral hygiene
Who cannot join
- Vitamin D deficient patients (<12 ng/ml), already using vitamin D supplements Presence of any systemic disease, such as uncontrolled diabetes, that may affect implant success, Smoking, Presence of untreated periodontitis, Previous exposure to radiotherapy in the head and neck area, Presence of osteoporosis or other metabolic bone diseases, Usage of oral/intravenous bisphosphonates, History of bone grafting and/or sinus lift, Long-term corticosteroid usage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin-D Insufficiency Leads to Interleukin-10 Reduction in Peri-implant Tissues: A Case-Control Study
Vitamin D is important for bone health, immune function, and inflammation, along with dental implant success. The study aimed to assess bone markers and cytokine levels in patients with and without vitamin D insufficiency to better understand the effects of vitamin D levels on dental implant integration. The study included 42 patients in 2 groups; with insufficient (Group IN-S; n=21) and sufficient (Group S; n=21) levels of vitamin D. Bone remodelling, proinflammatory and antiinflammatory markers were analyzed in bone and peri-implant crevicular fluid (PICF) using enzyme-linked immunosorbent assay (ELISA) and results were reported as concentration and total amount.
Read the detailed description
Background: Vitamin D is crucial for bone mineralization and plays a significant role in immune and inflammatory responses. Its deficiency is highly prevalent and might alter osseointegration of dental implants. Since successful osseointegration is a critical aspect of implant survival and the effects of vitamin D on implant osseointegration have not been well documented, the aim of this study was to evaluate bone markers and cytokine levels of patients with or without vitamin D insufficiency. Methods: A total of 42 patients were included and divided into two groups: Vitamin D insufficient (Group IN-S; n=21) and Vitamin D sufficient (Group S; n=21). Besides clinical periodontal parameters and implant stability measurements, bone and peri-implant crevicular fluid (PICF) levels of Receptor Activator of Nuclear Factor Kappa B Ligand (RANKL), osteoprotegerin (OPG), osteocalcin (OC), calcium (Ca), tumour necrosis factor alpha (TNF-α), Interleukin 1β (IL-1β), caspase-1 and Interleukin 10 (IL-10) were determined by enzyme-linked immunosorbent assay (ELISA). Results were represented as concentration and total amount.
- Being tested
- OPG, OC, RANKL, IL-10, IL-1β, Ca, TNF-α and Caspase-1 ELISA, Resonance Frequency Analysis, Periodontal clinical examination, Dental implant placement and bone sample collection, Gingival Crevicular Fluid Sampling
- Keywords
- RANKL, calcium, IL-10, vitamin D, osseointegration
- Medical subject headings
- Vitamin D Deficiency, Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPG, OC, RANKL, IL-10, IL-1β, Ca, TNF-α and Caspase-1 ELISADiagnostic test
The levels of OPG, OC, RANKL, IL10, IL1β, Ca, TNF-α and Caspase1 in bone and PICF of patients with or without Vitamin D sufficiency were measured by ELISA.
Resonance Frequency AnalysisDiagnostic test
Implant stability was measured by a device (Penguin RFA, Integration Diagnostics, Sweden) based on Resonance Frequency Analysis (RFA) and categorized by Implant Stability Quotient (ISQ) scale.
Periodontal clinical examinationDiagnostic test
Clinical periodontal indices including plaque index (PI) (Silness and Löe 1964), gingival index (GI) (Löe 1967), probing depth (PD), and bleeding on probing (BOP) (Ainamo and Bay 1975) were recorded using a Williams periodontal probe. The BOP percentage (%) was calculated by dividing the number of bleeding sites by the total number of sites examined.
Dental implant placement and bone sample collectionProcedure or surgery
All patients were received by a single examiner a bone level implant (standard type and Sandblasted, Large-grit, Acid-etched surface) (Implant Swiss, Yverdon, Switzerland).
Gingival Crevicular Fluid SamplingProcedure or surgery
One month after the healing caps were inserted, peri-implant crevicular fluid (PISF) samples were collected from 6 different sides of each implant. Before sampling, the area was isolated and dried, and paper strips were gently kept in periimplant sulcus for 30 seconds. Strips with blood or saliva contamination were discarded. PISF volumes of each strip were measured by a device (Periotron 8,010, Oraflow Inc, USA). Strips were then pooled, and inserted into tubes. PISF was recovered from paper strips through agitation in phosphate buffer saline (50 mM Tris-HCl, 5 mM CaCl2, 0.2 M NaCl,pH 7.5). All samples were stored at -80C until the day of analysis.
| Study group | Role | What they receive |
|---|---|---|
| vitamin D sufficient | Vitamin D sufficient group (Group S) >20 ng/ml threshold was determined as sufficiency, Receives: Diagnostic Test: OPG, OC, RANKL, IL-10, IL-1β, Ca, TNF-α and Caspase-1 ELISA; Diagnostic Test: Resonance Frequency Analysis; Diagnostic Test: Periodontal clinical examination; Procedure: Dental implant placement and bone sample collection; Procedure: Gingival Crevicular Fluid Sampling | |
| vitamin d insufficient | Vitamin D insufficient group (Group IN-S) 12-20 ng/mol was determined as insufficiency. Receives: Diagnostic Test: OPG, OC, RANKL, IL-10, IL-1β, Ca, TNF-α and Caspase-1 ELISA; Diagnostic Test: Resonance Frequency Analysis; Diagnostic Test: Periodontal clinical examination; Procedure: Dental implant placement and bone sample collection; Procedure: Gingival Crevicular Fluid Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline to 3 months for IL10 and RANKL
PICF and bone levels of markers were measured at baseline and at 3 months in both groups
Measured: 0 to 3 months
change from baseline to 3 months for RFA
Measurement of primary and secondary implant stability were performed at baseline and at 3 months in both groups
Measured: 0 to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Jan 2022
- Primary completion1 Jun 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vesile Elif Toy
- Sponsor type
- University, hospital or other
- Collaborators
- Inonu University
- Responsible party
- Sponsor-investigator, Vesile Elif Toy, Inonu University
- Investigators
- Vesile E Toy, Phd, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452251
- Sponsor's protocol ID
- TSA-2022-2992
- Status last verified
- Jul 2024
- First submitted
- 30 May 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data will be shared upon request by primary investigator Dr Vesile Elif toy elif.toy@inonu.edu.tr
Publications
Akkaya HU, Yilmaz HE, Narin F, Saglam M. Evaluation of galectin-3, peptidylarginine deiminase-4, and tumor necrosis factor-alpha levels in gingival crevicular fluid for periodontal health, gingivitis, and Stage III Grade C periodontitis: A pilot study. J Periodontol. 2022 Jan;93(1):80-88. doi: 10.1002/JPER.21-0137. Epub 2021 May 10.
PubMed 33913157Kwiatek J, Jaron A, Trybek G. Impact of the 25-Hydroxycholecalciferol Concentration and Vitamin D Deficiency Treatment on Changes in the Bone Level at the Implant Site during the Process of Osseointegration: A Prospective, Randomized, Controlled Clinical Trial. J Clin Med. 2021 Feb 2;10(3):526. doi: 10.3390/jcm10030526.
PubMed 33540512Franco-Topete R, Zepeda-Nuno JS, Zamora-Perez AL, Fuentes-Lerma MG, Gomez-Meda BC, Guerrero-Velazquez C. IFN-gammaR2 is strongly expressed on endothelial cells of gingival tissues from patients with chronic periodontitis. J Appl Oral Sci. 2018 Oct 4;26:e20170291. doi: 10.1590/1678-7757-2017-0291.
PubMed 30304122
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin-D Insufficiency Leads to Interleukin-10 Reduction in Peri-implant Tissues: A Case-Control Study
- ClinicalTrials.gov ID
- NCT06452251
- Acronym / sponsor ID
- TSA-2022-2992
- Keywords
- RANKL, calcium, IL-10, vitamin D, osseointegration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Vesile Elif ToyUniversity, hospital or other
- Collaborators
- Inonu University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 11 Jun 2024 (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.
Vitamin D is important for bone health, immune function, and inflammation, along with dental implant success. The study aimed to assess bone markers and cytokine levels in patients with and without vitamin D insufficiency to better understand the effects of vitamin D levels on dental implant integration. The study included 42 patients in 2 groups; with insufficient (Group IN-S; n=21) and sufficient (Group S; n=21) levels of vitamin D. Bone remodelling, proinflammatory and antiinflammatory markers were analyzed in bone and peri-implant crevicular fluid (PICF) using enzyme-linked immunosorbent assay (ELISA) and results were reported as concentration and total amount.
Detailed description
Background: Vitamin D is crucial for bone mineralization and plays a significant role in immune and inflammatory responses. Its deficiency is highly prevalent and might alter osseointegration of dental implants. Since successful osseointegration is a critical aspect of implant survival and the effects of vitamin D on implant osseointegration have not been well documented, the aim of this study was to evaluate bone markers and cytokine levels of patients with or without vitamin D insufficiency. Methods: A total of 42 patients were included and divided into two groups: Vitamin D insufficient (Group IN-S; n=21) and Vitamin D sufficient (Group S; n=21). Besides clinical periodontal parameters and implant stability measurements, bone and peri-implant crevicular fluid (PICF) levels of Receptor Activator of Nuclear Factor Kappa B Ligand (RANKL), osteoprotegerin (OPG), osteocalcin (OC), calcium (Ca), tumour necrosis factor alpha (TNF-α), Interleukin 1β (IL-1β), caspase-1 and Interleukin 10 (IL-10) were determined by enzyme-linked immunosorbent assay (ELISA). Results were represented as concentration and total amount.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D sufficient | – | Diagnostic Test: OPG, OC, RANKL, IL-10, IL-1β, Ca, TNF-α and Caspase-1 ELISA, Diagnostic Test: Resonance Frequency Analysis, Diagnostic Test: Periodontal clinical examination, Procedure: Dental implant placement and bone sample collection, Procedure: Gingival Crevicular Fluid SamplingVitamin D sufficient group (Group S) >20 ng/ml threshold was determined as sufficiency, |
| vitamin d insufficient | – | Diagnostic Test: OPG, OC, RANKL, IL-10, IL-1β, Ca, TNF-α and Caspase-1 ELISA, Diagnostic Test: Resonance Frequency Analysis, Diagnostic Test: Periodontal clinical examination, Procedure: Dental implant placement and bone sample collection, Procedure: Gingival Crevicular Fluid SamplingVitamin D insufficient group (Group IN-S) 12-20 ng/mol was determined as insufficiency. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For the Vitamin D sufficient group (Group S) >20 ng/ml threshold was determined as vitamin D sufficient, and Vitamin D insufficient group (Groups IN-S) 12-20 ng/mol was determined as insufficient. Vitamin D deficient patients (<12 ng/ml), already using vitamin D supplements, were not included in the current study.
Key inclusion criteria (2 listed)
- Being volunteer to participate in the study, For the Vitamin D sufficient group (Group S) having a vitamin D level >20 ng/ml; and 12-20 ng/ml for Vitamin D insufficient group (Groups IN-S).
- Having sufficient bone height and width at the edentulous areas, Not having a systemic disease that may adversely affect osseointegration, Not smoking Maintaining oral hygiene
Key exclusion criteria (1 listed)
- Vitamin D deficient patients (<12 ng/ml), already using vitamin D supplements Presence of any systemic disease, such as uncontrolled diabetes, that may affect implant success, Smoking, Presence of untreated periodontitis, Previous exposure to radiotherapy in the head and neck area, Presence of osteoporosis or other metabolic bone diseases, Usage of oral/intravenous bisphosphonates, History of bone grafting and/or sinus lift, Long-term corticosteroid usage.
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 |
|---|---|---|
| OPG, OC, RANKL, IL-10, IL-1β, Ca, TNF-α and Caspase-1 ELISAThe levels of OPG, OC, RANKL, IL10, IL1β, Ca, TNF-α and Caspase1 in bone and PICF of patients with or without Vitamin D sufficiency were measured by ELISA. | Diagnostic test | vitamin D sufficient, vitamin d insufficient |
| Resonance Frequency AnalysisImplant stability was measured by a device (Penguin RFA, Integration Diagnostics, Sweden) based on Resonance Frequency Analysis (RFA) and categorized by Implant Stability Quotient (ISQ) scale. | Diagnostic test | vitamin D sufficient, vitamin d insufficient |
| Periodontal clinical examinationClinical periodontal indices including plaque index (PI) (Silness and Löe 1964), gingival index (GI) (Löe 1967), probing depth (PD), and bleeding on probing (BOP) (Ainamo and Bay 1975) were recorded using a Williams periodontal probe. The BOP percentage (%) was calculated by dividing the number of bleeding sites by the total number of sites examined. | Diagnostic test | vitamin D sufficient, vitamin d insufficient |
| Dental implant placement and bone sample collectionAll patients were received by a single examiner a bone level implant (standard type and Sandblasted, Large-grit, Acid-etched surface) (Implant Swiss, Yverdon, Switzerland). | Procedure or surgery | vitamin D sufficient, vitamin d insufficient |
| Gingival Crevicular Fluid SamplingOne month after the healing caps were inserted, peri-implant crevicular fluid (PISF) samples were collected from 6 different sides of each implant. Before sampling, the area was isolated and dried, and paper strips were gently kept in periimplant sulcus for 30 seconds. Strips with blood or saliva contamination were discarded. PISF volumes of each strip were measured by a device (Periotron 8,010, Oraflow Inc, USA). Strips were then pooled, and inserted into tubes. PISF was recovered from paper strips through agitation in phosphate buffer saline (50 mM Tris-HCl, 5 mM CaCl2, 0.2 M NaCl,pH 7.5). All samples were stored at -80C until the day of analysis. | Procedure or surgery | vitamin D sufficient, vitamin d insufficient |
Primary outcome
change from baseline to 3 months for IL10 and RANKL
Time frame: 0 to 3 months
PICF and bone levels of markers were measured at baseline and at 3 months in both groups
change from baseline to 3 months for RFA
Time frame: 0 to 3 months
Measurement of primary and secondary implant stability were performed at baseline and at 3 months in both groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 33913157Akkaya HU, Yilmaz HE, Narin F, Saglam M. Evaluation of galectin-3, peptidylarginine deiminase-4, and tumor necrosis factor-alpha levels in gingival crevicular fluid for periodontal health, gingivitis, and Stage III Grade C periodontitis: A pilot study. J Periodontol. 2022 Jan;93(1):80-88. doi: 10.1002/JPER.21-0137. Epub 2021 May 10.
- Background: PubMed 33540512Kwiatek J, Jaron A, Trybek G. Impact of the 25-Hydroxycholecalciferol Concentration and Vitamin D Deficiency Treatment on Changes in the Bone Level at the Implant Site during the Process of Osseointegration: A Prospective, Randomized, Controlled Clinical Trial. J Clin Med. 2021 Feb 2;10(3):526. doi: 10.3390/jcm10030526.
- Background: PubMed 30304122Franco-Topete R, Zepeda-Nuno JS, Zamora-Perez AL, Fuentes-Lerma MG, Gomez-Meda BC, Guerrero-Velazquez C. IFN-gammaR2 is strongly expressed on endothelial cells of gingival tissues from patients with chronic periodontitis. J Appl Oral Sci. 2018 Oct 4;26:e20170291. doi: 10.1590/1678-7757-2017-0291.
- Individual participant dataSharing planned: Yes. Study data will be shared upon request by primary investigator Dr Vesile Elif toy elif.toy@inonu.edu.tr
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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. This study is not recruiting at the moment.
Vesile E Toy, Phd principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Osseointegration Failure of Dental Implant, run by Vesile Elif Toy 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 2 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: finished, as of the sponsor's last update on 16 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline to 3 months for IL10 and RANKL (time frame: 0 to 3 months). 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?
On the ClinicalTrials.gov record for NCT06452251, which also lists 3 linked publications.
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 16 Jul 2024; AzTrials last refreshed its copy on 27 Oct 2026.