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Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid

NCT ID: NCT07280754

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-30

Study Completion Date

2026-06-01

Brief Summary

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Despite technological advances that have significantly improved dental implant osseointegration and survival rates, biological complications such as peri-implantitis and peri-implant mucositis are common around the implant. The active form of vitamin D, 1,25-dihydroxyvitamin D3 (1,25(OH)2D3), can be induced by the expression of leucine-lysine-37 (LL-37), a human antimicrobial peptide in the cathelicidin family. Studies have shown that 1,25(OH)2D3 and its precursor, 25(OH)D3, significantly reduce inflammation by suppressing the release of receptor activator nuclear factor kappa b ligand (RANKL), tumor necrosis factor-alpha (TNF-α), interleukin (IL)-1, and IL-6, and by preventing alveolar bone loss. To date, many cytokines have been investigated in peri-implant sulcus fluid (PIOS). The lack of a direct study investigating vitamin D and LL-37 levels in PIOS constitutes the unique value of this project. This study aims to compare LL-37 and 25(OH)D3 levels in PIOS and examine their correlation with markers such as IL-6, IL-10, and MMP-8, as well as clinical parameters. Volunteers aged 18-65 who have received dental implants at the Recep Tayyip Erdoğan University Faculty of Dentistry and have been using their implant-supported prosthesis for at least one year and who have been informed about this study will be included in the study. The groups will be formed as peri-implant health, peri-implant mucositis, and peri-implantitis. The implants of the patients included in the study will be evaluated for probed pocket depth (PPD), clinical attachment level (CAL), suppuration (S), modified gingival index (mGI), plaque index (mPI), bleeding index (mBI), keratinized gingival amount, and attached gingival amount. PIOS and serum samples will be obtained from patients, and their relationship to periodontal status and each other will be statistically evaluated.

This project may help discover new biomarkers that can be used in the early diagnosis of peri-implantar diseases. This study could contribute to earlier treatment, lower patient costs, and even the development of new treatment plans for these diseases.

Detailed Description

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Conditions

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Peri Implantitis Peri Implant Mucositis

Keywords

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LL-37 peri-implanter sulcus fluid peri-implantitis vitamin D

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy group

Criteria such as absence of clinical signs of inflammation in the tissues, absence of bleeding on probing, PPD ≤5.0 mm, and absence of bone loss greater than 2 mm after initial healing will be sought.

No interventions assigned to this group

peri-implant mucositis

Criteria such as clinical signs of inflammation (erythema, swelling, suppuration) in the tissues, bleeding on probing, and an PPD of 5.0 mm will be sought. At the time of implant placement, the height of the surrounding soft tissue influences the initial probing depth.

No interventions assigned to this group

periimplantitis

Bleeding, inflammation, redness, edema, suppuration, and in addition to these, bone loss \>5 mm and radiographically observed in PPD are observed in the tissues.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Being between the ages of 18-65,
* Having dental implants and using implant-supported prostheses for at least one year,
* Not having used systemic and/or topical antibiotics/anti-inflammatory drugs or mouthwashes in the last three months,
* Not having received periodontal/peri-implant treatment in the last six months.

Exclusion Criteria

* Having a systemic disease or condition that affects peri-implant status,
* Having a metabolic bone disease,
* Bruxism,
* Being pregnant or lactating,
* Having received periodontal/peri-implant treatment within the last 6 months,
* Smoking and alcohol use,
* Taking vitamin D supplements.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Recep Tayyip Erdogan University

OTHER

Sponsor Role lead

Responsible Party

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Melek Beder

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Recep Tayyip Erdogan U

Identifier Type: -

Identifier Source: org_study_id