Peri-Implantitis and Peri-implant MucositisNCT06867250
Peri-implant Vitamin D and Cathelicidin (LL-37) Levels
An observational study of Peri-Implantitis and Peri-implant Mucositis, run by Altinbas University at 1 site in Turkey (Türkiye).
Trial summary
This research aims to explore the influence of vitamin D on the body's defense system by examining its impact on specific proteins involved in immune response and inflammation in the soft tissues surrounding dental implants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis and Peri-implant Mucositis
- What is being tested?
- The patients' periodontal clinical parameters were recorded. PISF samples were collected, and the evaluations of 25(OH)D and LL-37 were conducted using enzyme-linked immunosorbent assay.
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Dec 2021
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This cross-sectional clinical study included 33 patients with dental implants, exhibiting either healthy peri-implant tissues or peri-implant diseases, who sought treatment at the Department of Periodontology, Faculty of Dentistry, Altınbaş University.
Who may be able to join
- Not received peri-implant treatment in the previous six months.
- Had not used vitamin D supplements, antibiotics, anti-inflammatory drugs, or any medications that could affect peri-implant tissues in the last three months.
- Patients with dental implants had been in function for at least 12 months, had been under functional loading for at least six months, and had prosthetic superstructures that allowed for unobstructed sample collection.
Who cannot join
- Uncontrolled systemic conditions, disorders affecting peri-implant tissues, metabolic bone diseases, autoimmune disorders.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Peri-Implant Sulcus Fluid Vitamin D and Cathelicidin (LL-37) Levels in Peri-Implant Health and Diseases
This research aims to explore the influence of vitamin D on the body's defense system by examining its impact on specific proteins involved in immune response and inflammation in the soft tissues surrounding dental implants. Also aims to determine how vitamin D levels affect these proteins and their role in protecting peri-implant tissues from microbial infections and inflammation.
Read the detailed description
This cross-sectional clinical study examined 33 patients with 105 dental implants, classified as having either healthy peri-implant tissues or peri-implant diseases. Participants had not received peri-implant treatment in the past six months or taken medications affecting peri-implant tissues in the last three months. Eligible implants had been functional for at least 12 months with prosthetic superstructures that allowed sample collection. Patients with uncontrolled systemic conditions, metabolic bone diseases, autoimmune disorders, or those who were pregnant or breastfeeding were excluded.
Clinical assessments were conducted at six peri-implant sites, measuring probing depth (PD), clinical attachment level (CAL), modified plaque index (mPI), modified sulcus bleeding index (mSBI), and keratinized mucosa width (KMW). Bone loss was evaluated using radiographs. Patients were categorized into three groups based on the 2017 Classification of Periodontal and Peri-implant Diseases: peri-implant health, peri-implant mucositis, and peri-implantitis (35 implants per group).
Peri-implant sulcus fluid (PISF) samples were collected for 25(OH)D and LL-37 analysis using enzyme-linked immunosorbent assay (ELISA). Statistical analysis included normality tests (Kolmogorov-Smirnov), descriptive statistics, one-way ANOVA with Tukey HSD, Kruskal-Wallis with Dunn's test, chi-square tests, and Spearman's correlation for non-normally distributed data.
- Being tested
- The patients' periodontal clinical parameters were recorded. PISF samples were collected, and the evaluations of 25(OH)D and LL-37 were conducted using enzyme-linked immunosorbent assay.
- Keywords
- peri-implant sulcus fluid, peri-implant diseases, LL-37, 25(OH)D
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The patients' periodontal clinical parameters were recorded. PISF samples were collected, and the evaluations of 25(OH)D and LL-37 were conducted using enzyme-linked immunosorbent assay.Diagnostic test
In vitro studies have shown that vitamin D promotes the release of antimicrobial peptides from gingival epithelial cells, no clinical research has specifically examined its effect on LL-37 levels in peri-implant tissue diseases. This study seeks to investigate the relationship between vitamin D levels in peri-implant sulcus fluid and clinical parameters in individuals with both peri-implant health and disease. Additionally, it aims to assess the correlation between vitamin D and the antimicrobial peptide LL-37.
| Study group | Role | What they receive |
|---|---|---|
| peri-implant healthy, peri-implant mucositis, peri-implantitis | A total of 105 dental implants from 33 patients were assessed, with 35 categorized in the peri-implant health group, 35 in the peri-implant mucositis group, and 35 in the peri-implantitis group. Receives: Diagnostic Test: The patients' periodontal clinical parameters were recorded. PISF samples were collected, and the evaluations of 25(OH)D and LL-37 were conducted using enzyme-linked immunosorbent assay. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant sulcus fluid vitamin D levels and clinical parameters correlation
The association between vitamin D levels in peri-implant sulcus fluid and clinical parameters in individuals with peri-implant health and peri-implant diseases.
Measured: At the day of visit (Day 0)- Peri-implant clinical assessments and peri-implant sulcus fluid collection
The correlation between vitamin D and the antimicrobial peptide LL-37
Peri-implant sulcus fluid Vitamin d and LL-37 levels were investigated with ELISA
Measured: Laboratory tests were completed after all samples were collected.
Mucosal Inflammation
Measurement of mucosal inflammation around implants using modified plaque index (mPI), and modified sulcus bleeding index (mSBI).
Measured: At the day of visit (Day 0)
Probing Pocket Depth
Measurement of the periodontal pockets depth around implants. Unit of Measure: Millimeters (mm)
Measured: At the day of visit (Day 0)
Width of Keratinized Mucosa
Measurement of the width of keratinized mucosa around the implants. Unit of Measure: Millimeters (mm)
Measured: At the day of visit (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Apr 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-Implantitis and Peri-implant MucositisStudies 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
- Cross-sectional
- Enrolment
- 33 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Altinbas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKNUR OZENCI, Altinbas University
- Investigators
- ILKNUR OZENCI, Dr, Principal investigator, Altinbas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867250
- Sponsor's protocol ID
- 2021/45
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This detailed description provides a comprehensive overview of your study, outlining its objectives, background, methodology, and expected outcomes in a structured and academic manner.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peri-Implant Sulcus Fluid Vitamin D and Cathelicidin (LL-37) Levels in Peri-Implant Health and Diseases
- ClinicalTrials.gov ID
- NCT06867250
- Acronym / sponsor ID
- 2021/45
- Keywords
- peri-implant sulcus fluid, peri-implant diseases, LL-37, 25(OH)D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Altinbas UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 10 Mar 2025 (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.
This research aims to explore the influence of vitamin D on the body's defense system by examining its impact on specific proteins involved in immune response and inflammation in the soft tissues surrounding dental implants. Also aims to determine how vitamin D levels affect these proteins and their role in protecting peri-implant tissues from microbial infections and inflammation.
Detailed description
This cross-sectional clinical study examined 33 patients with 105 dental implants, classified as having either healthy peri-implant tissues or peri-implant diseases. Participants had not received peri-implant treatment in the past six months or taken medications affecting peri-implant tissues in the last three months. Eligible implants had been functional for at least 12 months with prosthetic superstructures that allowed sample collection. Patients with uncontrolled systemic conditions, metabolic bone diseases, autoimmune disorders, or those who were pregnant or breastfeeding were excluded.
Clinical assessments were conducted at six peri-implant sites, measuring probing depth (PD), clinical attachment level (CAL), modified plaque index (mPI), modified sulcus bleeding index (mSBI), and keratinized mucosa width (KMW). Bone loss was evaluated using radiographs. Patients were categorized into three groups based on the 2017 Classification of Periodontal and Peri-implant Diseases: peri-implant health, peri-implant mucositis, and peri-implantitis (35 implants per group).
Peri-implant sulcus fluid (PISF) samples were collected for 25(OH)D and LL-37 analysis using enzyme-linked immunosorbent assay (ELISA). Statistical analysis included normality tests (Kolmogorov-Smirnov), descriptive statistics, one-way ANOVA with Tukey HSD, Kruskal-Wallis with Dunn's test, chi-square tests, and Spearman's correlation for non-normally distributed data.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peri-implant healthy, peri-implant mucositis, peri-implantitis | – | Diagnostic Test: The patients' periodontal clinical parameters were recorded. PISF samples were collected, and the evaluations of 25(OH)D and LL-37 were conducted using enzyme-linked immunosorbent assay.A total of 105 dental implants from 33 patients were assessed, with 35 categorized in the peri-implant health group, 35 in the peri-implant mucositis group, and 35 in the peri-implantitis group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This cross-sectional clinical study included 33 patients with dental implants, exhibiting either healthy peri-implant tissues or peri-implant diseases, who sought treatment at the Department of Periodontology, Faculty of Dentistry, Altınbaş University.
Key inclusion criteria (3 listed)
- Not received peri-implant treatment in the previous six months.
- Had not used vitamin D supplements, antibiotics, anti-inflammatory drugs, or any medications that could affect peri-implant tissues in the last three months.
- Patients with dental implants had been in function for at least 12 months, had been under functional loading for at least six months, and had prosthetic superstructures that allowed for unobstructed sample collection.
Key exclusion criteria (2 listed)
- Uncontrolled systemic conditions, disorders affecting peri-implant tissues, metabolic bone diseases, autoimmune disorders.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| The patients' periodontal clinical parameters were recorded. PISF samples were collected, and the evaluations of 25(OH)D and LL-37 were conducted using enzyme-linked immunosorbent assay.In vitro studies have shown that vitamin D promotes the release of antimicrobial peptides from gingival epithelial cells, no clinical research has specifically examined its effect on LL-37 levels in peri-implant tissue diseases. This study seeks to investigate the relationship between vitamin D levels in peri-implant sulcus fluid and clinical parameters in individuals with both peri-implant health and disease. Additionally, it aims to assess the correlation between vitamin D and the antimicrobial peptide LL-37. | Diagnostic test | peri-implant healthy, peri-implant mucositis, peri-implantitis |
Primary outcome
Peri-implant sulcus fluid vitamin D levels and clinical parameters correlation
Time frame: At the day of visit (Day 0)- Peri-implant clinical assessments and peri-implant sulcus fluid collection
The association between vitamin D levels in peri-implant sulcus fluid and clinical parameters in individuals with peri-implant health and peri-implant diseases.
The correlation between vitamin D and the antimicrobial peptide LL-37
Time frame: Laboratory tests were completed after all samples were collected.
Peri-implant sulcus fluid Vitamin d and LL-37 levels were investigated with ELISA
Mucosal Inflammation
Time frame: At the day of visit (Day 0)
Measurement of mucosal inflammation around implants using modified plaque index (mPI), and modified sulcus bleeding index (mSBI).
Probing Pocket Depth
Time frame: At the day of visit (Day 0)
Measurement of the periodontal pockets depth around implants. Unit of Measure: Millimeters (mm)
Width of Keratinized Mucosa
Time frame: At the day of visit (Day 0)
Measurement of the width of keratinized mucosa around the implants. Unit of Measure: Millimeters (mm)
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 10 Mar 2025.
- Individual participant dataSharing planned: No. This detailed description provides a comprehensive overview of your study, outlining its objectives, background, methodology, and expected outcomes in a structured and academic manner.
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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.
ILKNUR OZENCI, Dr principal investigator
Altinbas 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 Peri-Implantitis and Peri-implant Mucositis, run by Altinbas University 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 3 inclusion and 2 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 10 Mar 2025. 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?
Peri-implant sulcus fluid vitamin D levels and clinical parameters correlation (time frame: At the day of visit (Day 0)- Peri-implant clinical assessments and peri-implant sulcus fluid collection). The study lists 5 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 Mar 2025.