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临床试验/NCT07200011
NCT07200011进行中(未招募)不适用

Effect of Serum Vitamin D Levels on the Clinical and Radiographic Outcomes of Unsplinted Mandibular Implant Overdentures

Mansoura University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Correlation between serum vitamin D levels and radiographic marginal bone loss around unsplinted mandibular implant overdentures

研究概览

简要总结

This study investigates the effect of vitamin D on bone loss around mandibular implant overdentures. Bone levels around implants will be measured to understand how vitamin Daffect the health of implant-supported dentures. This information may help improve dental treatment outcomes

详细描述

Tooth loss affects patient's quality of life. The use of mandibular implant overdentures is an accepted treatment option that improves prosthesis retention, stability, and masticatory efficiency compared to conventional complete dentures.

Vitamin D plays a critical role in bone metabolism and osseointegration of dental implants. Deficiency may impair bone healing and accelerate peri-implant bone loss.

The purpose of this retrospective study is to clinically and radiographically evaluate the effect of serum vitamin D levels on peri-implant tissues in patients rehabilitated with unsplinted mandibular implant overdentures.

Patient records are screened for serum vitamin D levels, radiographs at baseline of loading and follow-up intervals ( 6 & 12 months after loading )and clinical notes.

Patients categorize into two groups based on their recorded serum vitamin D levels: group A - deficient vitamin D : < 20 ng/mL and group B - sufficient vitamin D: ≥ 30 ng/mL.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Age between 40 and 60 years.
  • Patients rehabilitated with unsplinted three-implant mandibular overdentures retained by LOCATOR attachments .
  • Availability of recent serum vitamin D records at determined time intervals.
  • Good general health without uncontrolled systemic diseases.

排除标准

  • Missing or incomplete patient records.
  • Patients on medications known to affect bone metabolism.
  • History of smoking or alcohol abuse.
  • Patients with borderline serum vitamin D values (21-29 ng/mL) to avoid classification bias.
  • Presence of active oral infections or untreated periodontal disease.
  • Previous implant failure in the mandible.

结局指标

主要结局

Correlation between serum vitamin D levels and radiographic marginal bone loss around unsplinted mandibular implant overdentures

时间窗: Baseline (prosthetic loading), 6 months, 12 months after loading (T0,T6,T12)

Marginal bone loss vertically (VBL) and horizontally (HBL) around each unsplinted mandibular dental implant are measured on standardized digital periapical radiographs using Scanora Light software (mm). Serum vitamin D levels (ng/mL) are obtained from patient records. The correlation between serum vitamin D concentration and marginal bone loss will be analyzed.

次要结局

  • Clinical & peri-implant outcomes of unsplinted mandibular implant overdentures Peri-implant soft tissue health: plaque index , gingival index, bleeding on probing(Baseline (prosthetic loading), 6 months, 12 months after loading T0, T6,T12)
  • Clinical and peri-implant parameters are assessed from patient avilable records and clinical examinations: probing pocket depth(Baseline (prosthetic loading), 6 months, 12 months after loading T0, T6,T12)
  • Implant status including mobility and presence of peri-implant infection or suppuration were also evaluated and recorded in all patients data.(Baseline (prosthetic loading), 6 months, 12 months after loading T0, T6,T12)
  • Prosthesis-related factors, including stability, retention, and occlusion, were assessed clinically.(Baseline (prosthetic loading), 6 months, 12 months after loading T0, T6,T12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rahma elhussany mohammed

Lecturer, Department of Prosthodontics, Mansoura faculty of Dentistry, Egypt

Mansoura University

研究点 (1)

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