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Not yet recruiting NCT07557459

Access to Probing and Peri-implant Diseases

Observational Peri-implantitis Peri-implant Bone Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peri-implant probing.
Who it may be relevant to
Registry conditions: Peri-implantitis, Peri-implant Bone Loss. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Access to Peri-implant Probing and Its Association With Peri-implant Diseases: A Multicenter Cross-Sectional Study

Overview

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 test Peri-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 accordin

Primary outcome measures

  • Association between probing access and peri-implant radiographic bone loss [Time frame: Baseline (cross-sectional assessment)]
Secondary outcome measures (5)
  • Prevalence of implants with limited or no probing accessibility [Time frame: Assessed at the baseline visit (single cross-sectional evaluation)]
  • Prevalence of non-hygienizable implant-supported prostheses [Time frame: Assessed at the baseline visit (single cross-sectional evaluation)]
  • Association between hygiene accessibility and peri-implant bone loss [Time frame: Assessed at the baseline visit (single cross-sectional evaluation)]
  • Clinical peri-implant parameters [Time frame: Assessed at the baseline visit (single cross-sectional evaluation)]
  • Patient-related and implant-related factors associated with probing accessibility [Time frame: Assessed at the baseline visit (single cross-sectional evaluation)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07557459 · 01924

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗