Peri-implant Bone Loss, Peri-implantitis
Conditions
Keywords
Peri-implantitis, Dental Implants, Probing, Bone Loss, Prosthetic Design, Oral Hygiene, Cross-sectional Study
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.
Interventions
DIAGNOSTIC_TESTPeri-implant probing
This is a non-interventional, observational cross-sectional multicenter study. No therapeutic, surgical, or pharmacological interventions are performed as part of the study. All procedures correspond to standard clinical practice and include: Peri-implant clinical examination, consisting of probing depth measurements at six sites per implant using a manual periodontal probe. When access is limited, a flexible plastic probe may be used. Assessment of probing accessibility, categorized according to the angulation and feasibility of probe insertion without prosthesis removal (possible, limited, or impossible). Recording of routine clinical parameters, including plaque presence, bleeding on probing, suppuration, and patient-reported hygiene practices. Radiographic assessment, consisting of standardized periapical radiographs obtained using a parallel technique for the evaluation of marginal bone levels. No modifications to the patients' treatment, prosthetic design, or maintenance protocol
Sponsors
Arrow Development
Salud y Estetica Dental SCH Zurbano S.L
Clinica Dental Nexus, Malaga
Clinica Bio, Madrid
Centro de Periodoncia e Implantes Aranda-Macera, Madrid
Clínica Sánchez Cortés, Madrid
Madrid Perio & Implant Clinic, Madrid
Clínica Barbieri, A Coruña
Clinica Ortiz-Vigon, Bilbao
PerioCentrum Guadalajara
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association between probing access and peri-implant radiographic bone loss | 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
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of implants with limited or no probing accessibility | Assessed at the baseline visit (single cross-sectional evaluation) | Proportion of implants classified as having limited or impossible access to peri-implant probing, based on probe angulation and feasibility without prosthesis removal. |
| Prevalence of non-hygienizable implant-supported prostheses | Assessed at the baseline visit (single cross-sectional evaluation) | Proportion of implant-supported restorations classified as non-hygienizable, defined as the inability to pass an interdental brush of at least 0.4 mm diameter |
| Association between hygiene accessibility and peri-implant bone loss | Assessed at the baseline visit (single cross-sectional evaluation) | Evaluation of the relationship between prosthetic hygiene accessibility (hygienizable vs non-hygienizable) and radiographic peri-implant marginal bone levels. |
| Clinical peri-implant parameters | Assessed at the baseline visit (single cross-sectional evaluation) | Assessment of peri-implant clinical parameters, including plaque presence, bleeding on probing, suppuration, and probing depth (when measurable), in relation to probing accessibility. |
| Patient-related and implant-related factors associated with probing accessibility | Assessed at the baseline visit (single cross-sectional evaluation) | Exploratory analysis of the association between probing accessibility and variables such as type of prosthesis (single, partial, full-arch), implant characteristics (bone level/tissue level, connection type), and patient-related factors (oral hygiene habits, maintenance frequency, history of periodontitis). |
Outcome results
None listed