Access to Probing and Peri-implant Diseases

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• Association between probing access and peri-implant radiographic bone loss [Срок оценки: Baseline (cross-sectional assessment)]

Вторичные конечные точки (5)

• Prevalence of implants with limited or no probing accessibility [Срок оценки: Assessed at the baseline visit (single cross-sectional evaluation)]
• Prevalence of non-hygienizable implant-supported prostheses [Срок оценки: Assessed at the baseline visit (single cross-sectional evaluation)]
• Association between hygiene accessibility and peri-implant bone loss [Срок оценки: Assessed at the baseline visit (single cross-sectional evaluation)]
• Clinical peri-implant parameters [Срок оценки: Assessed at the baseline visit (single cross-sectional evaluation)]
• Patient-related and implant-related factors associated with probing accessibility [Срок оценки: Assessed at the baseline visit (single cross-sectional evaluation)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Exposure of the intraosseous portion of the implant
• Evident prosthetic misfit
• Inability to provide informed consent
• Lack of cooperation for clinical examination

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07557459 · 01924

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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