- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07557459
Access to Probing and Peri-implant Diseases
Access to Peri-implant Probing and Its Association With Peri-implant Diseases: A Multicenter Cross-Sectional Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline (cross-sectional assessment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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)
|
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
|
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)
|
Evaluation of the relationship between prosthetic hygiene accessibility (hygienizable vs non-hygienizable) and radiographic peri-implant marginal bone levels.
|
Assessed at the baseline visit (single cross-sectional evaluation)
|
|
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.
|
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)
|
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).
|
Assessed at the baseline visit (single cross-sectional evaluation)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01924
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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