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临床试验/NCT07280754
NCT07280754尚未招募不适用

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

Recep Tayyip Erdogan University0 个研究点目标入组 72 人开始时间: 2025年12月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
72
主要终点
Probing pocket depth (PPD)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Probing pocket depth (PPD)

时间窗: 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)

时间窗: baseline

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

次要结局

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

研究者

发起方
Recep Tayyip Erdogan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melek Beder

Doctor

Recep Tayyip Erdogan University

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