Access to Probing and Peri-implant Diseases

NCT07557459 | Not Yet Recruiting

• 1 other identifier: 01924
• Study Type: observational
• Target: 281
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peri-implantitis; Peri-implant Bone Loss

Keywords

Peri-implantitis; Dental Implants; Probing; Bone Loss; Prosthetic Design; Oral Hygiene; Cross-sectional Study

Outcome Measures

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).

  Baseline (cross-sectional assessment)

Secondary Outcomes (5)

• Prevalence of implants with limited or no probing accessibility

  Assessed at the baseline visit (single cross-sectional evaluation)

• Prevalence of non-hygienizable implant-supported prostheses

  Assessed at the baseline visit (single cross-sectional evaluation)

• Association between hygiene accessibility and peri-implant bone loss

  Assessed at the baseline visit (single cross-sectional evaluation)

• Clinical peri-implant parameters

  Assessed at the baseline visit (single cross-sectional evaluation)

• Patient-related and implant-related factors associated with probing accessibility

  Assessed at the baseline visit (single cross-sectional evaluation)

Interventions

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Arrow Development: lead

MeSH Terms

Conditions

Peri-Implantitis; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Dentist (DDS, PhD, MBA)

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share