Access to Peri-implant Probing and Its Association With Peri-implant Diseases: A Multicenter Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 281
- 主要终点
- Association between probing access and peri-implant radiographic bone loss
研究概览
简要总结
This multicenter cross-sectional study aims to evaluate the association between access to peri-implant probing and radiographic peri-implant bone loss. Although probing is the primary diagnostic tool for peri-implant diseases, prosthetic design may limit access, potentially affecting diagnosis and disease progression. The study will include patients with dental implants in function for at least three years and will assess clinical, radiographic, and prosthetic variables.
详细描述
Peri-implantitis is a plaque-induced inflammatory condition characterized by inflammation of peri-implant tissues and progressive bone loss. Probing is essential for diagnosis; however, prosthetic design may hinder or prevent proper probing access, potentially compromising diagnostic accuracy.
Despite its clinical relevance, no studies have directly evaluated whether limited access to probing is associated with peri-implant bone loss. This study aims to address this gap.
This is a multicenter cross-sectional observational study conducted in nine private clinics in Spain. A total of 281 patients will be included. Clinical and radiographic data will be collected, including probing accessibility, probing depth, plaque index, bleeding on probing, suppuration, prosthetic design, hygiene accessibility, and radiographic bone levels.
Statistical analysis will evaluate associations between probing access and peri-implant bone loss at both patient and implant levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Dental implants loaded for at least 3 years
- •Implant-supported restorations (single, partial fixed, or full-arch)
- •First visit to the clinic (maintenance, review, or treatment)
- •Signed informed consent
- •Availability of clinical and radiographic records
排除标准
- •Exposure of the intraosseous portion of the implant
- •Evident prosthetic misfit
- •Inability to provide informed consent
- •Lack of cooperation for clinical examination
结局指标
主要结局
Association between probing access and peri-implant radiographic bone loss
时间窗: Baseline (cross-sectional assessment)
Evaluation of whether limited or impossible probing access is associated with increased radiographic bone loss (measured in mm from implant platform to bone level).
次要结局
- Prevalence of implants with limited or no probing accessibility(Assessed at the baseline visit (single cross-sectional evaluation))
- Prevalence of non-hygienizable implant-supported prostheses(Assessed at the baseline visit (single cross-sectional evaluation))
- Association between hygiene accessibility and peri-implant bone loss(Assessed at the baseline visit (single cross-sectional evaluation))
- Clinical peri-implant parameters(Assessed at the baseline visit (single cross-sectional evaluation))
- Patient-related and implant-related factors associated with probing accessibility(Assessed at the baseline visit (single cross-sectional evaluation))
研究者
Alberto Ortiz Vigon
Principal Investigator, Dentist (DDS, PhD, MBA)
Arrow Development