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Clinical Trials/NCT07280754
NCT07280754
Not yet recruiting
Not Applicable

Evaluation of 25(OH)D3 and LL-37 Levels in Peri-implant Sulcus Fluid in Peri-implant Diseases

Recep Tayyip Erdogan University0 sites72 target enrollmentStarted: December 30, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Recep Tayyip Erdogan University
Enrollment
72
Primary Endpoint
Probing pocket depth (PPD)

Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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,
  • 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)

Time Frame: baseline

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.

clinical attachment level (CAL)

Time Frame: baseline

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

Secondary Outcomes

  • 25-Hydroxy Vitamin D3 ((25(OH)D3))(baseline)
  • leucine leucine-37 (LL-37)(baseline)

Investigators

Sponsor
Recep Tayyip Erdogan University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Melek Beder

Doctor

Recep Tayyip Erdogan University

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