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NCT Number: NCT07557459

Access to Probing and Peri-implant Diseases

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peri-implant probing

Diagnostic Test

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

Primary outcomes

  1. 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

  1. Prevalence of implants with limited or no probing accessibility

    Time frame: 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.

  2. Prevalence of non-hygienizable implant-supported prostheses

    Time frame: 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

  3. Association between hygiene accessibility and peri-implant bone loss

    Time frame: 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.

  4. Clinical peri-implant parameters

    Time frame: 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.

  5. Patient-related and implant-related factors associated with probing accessibility

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Arrow Development

Industry

Collaborators

  • Centro de Periodoncia e Implantes Aranda-Macera, Madrid
  • Clinica Bio, Madrid
  • Clinica Dental Nexus, Malaga
  • Clinica Ortiz-Vigon, Bilbao
  • Clínica Barbieri, A Coruña
  • Clínica Sánchez Cortés, Madrid
  • Madrid Perio & Implant Clinic, Madrid
  • PerioCentrum Guadalajara
  • Salud y Estetica Dental SCH Zurbano S.L

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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