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

Recep Tayyip Erdogan University

Status: Not yet enrolling

Conditions: Peri Implant Mucositis; Peri Implantitis

Study type: Observational

Funder types: Other

Identifiers

NCT07280754

Recep Tayyip Erdogan U

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

72 participants in 3 patient groups

healthy group

Description:

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.

peri-implant mucositis

Description:

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.

periimplantitis

Description:

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