Access to Probing and Peri-implant Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorArrow Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Exposure of the intraosseous portion of the implant
Evident prosthetic misfit
Inability to provide informed consent
Lack of cooperation for clinical examination
Trial population
Adult patients attending participating clinics for the first time for maintenance, review, or treatment, with dental implants in function for at least three years
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Peri-implant probing
Diagnostic testThis 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
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Association between probing access and peri-implant radiographic bone loss
Evaluation of whether limited or impossible probing access is associated with increased radiographic bone loss (measured in mm from implant platform to bone level).
Time frame
Baseline (cross-sectional assessment)Secondary outcomes
1
Prevalence of implants with limited or no probing accessibility
Proportion of implants classified as having limited or impossible access to peri-implant probing, based on probe angulation and feasibility without prosthesis removal.
Time frame
Assessed at the baseline visit (single cross-sectional evaluation)2
Prevalence of non-hygienizable implant-supported prostheses
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
Time frame
Assessed at the baseline visit (single cross-sectional evaluation)3
Association between hygiene accessibility and peri-implant bone loss
Evaluation of the relationship between prosthetic hygiene accessibility (hygienizable vs non-hygienizable) and radiographic peri-implant marginal bone levels.
Time frame
Assessed at the baseline visit (single cross-sectional evaluation)4
Clinical peri-implant parameters
Assessment of peri-implant clinical parameters, including plaque presence, bleeding on probing, suppuration, and probing depth (when measurable), in relation to probing accessibility.
Time frame
Assessed at the baseline visit (single cross-sectional evaluation)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Arrow Development
Lead sponsor
Clinica Dental Nexus, Malaga
Collaborator
Salud y Estetica Dental SCH Zurbano S.L
Collaborator
Clinica Bio, Madrid
Collaborator
Centro de Periodoncia e Implantes Aranda-Macera, Madrid
Collaborator
Clínica Sánchez Cortés, Madrid
Collaborator
Madrid Perio & Implant Clinic, Madrid
Collaborator
Clínica Barbieri, A Coruña
Collaborator
Clinica Ortiz-Vigon, Bilbao
Collaborator
PerioCentrum Guadalajara
Collaborator
Source ClinicalTrials.gov