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

N/ANot Yet RecruitingNCT07280754

Recep Tayyip Erdogan University72 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Peri Implantitis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Probing pocket depth (PPD)

The distance from the gingival margin to the pocket base around the implants was measured in mm using a periodontal probe, at six locations for each implant. The average value will be determined for each implant circumference.

Time frame: baseline

clinical attachment level (CAL)

Similar to the PPD measurement, this will be done by determining the distance between the pocket base and the implant neck.

Time frame: baseline

Secondary Outcomes

25-Hydroxy Vitamin D3 ((25(OH)D3))

25(OH)D3 levels in PIOS samples will be analyzed by ELISA or CMIA methods.

Time frame: baseline

leucine leucine-37 (LL-37)

LL-37 levels in PIOS samples will be evaluated by ELISA method.

Time frame: baseline