Access to Peri-implant Probing and Its Association With Peri-implant Diseases: A Multicenter Cross-Sectional Study
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Arrow Development
- Enrollment
- 281
- Primary Endpoint
- Association between probing access and peri-implant radiographic bone loss
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Exposure of the intraosseous portion of the implant
- •Evident prosthetic misfit
- •Inability to provide informed consent
- •Lack of cooperation for clinical examination
Outcomes
Primary Outcomes
Association between probing access and peri-implant radiographic bone loss
Time Frame: 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).
Secondary Outcomes
- 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))
Investigators
Alberto Ortiz Vigon
Principal Investigator, Dentist (DDS, PhD, MBA)
Arrow Development