The Study on the Accuracy of Peri-implant Probing and Related Influencing Factors

NCT07004517 | Recruiting DMC

• 1 other identifier: 2019-51
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the diagnostic accuracy study was to compare the diagnostic accuracy of probing depth before (PPD-1) and following (PPD-2) the removal of prothesis in identifying the presence of peri-implantitis and assess the factors influencing peri-implant probing.

Conditions

Peri-Implantitis; Diagnosis

Outcome Measures

Primary Outcomes (1)

• probing depth

  The PPDs at 6 site were measured as the distance from the mucosal margin to the base of the peri-implant pocket.

  On the day of enrollment

Secondary Outcomes (3)

• bleeding on probing

  On the day of enrollment

• Emergency angel

  The X-ray examination will be completed on the day of enrollment

• Emergency profile

  The X-ray examination will be completed on the day of enrollment

Study Arms (1)

patients with dental implant restorations

Consecutive patients were selected who were treated at the Department of Oral Implantology, Stomatology Hospital, School of Medicine, Zhejiang University, Hangzhou, China,

Diagnostic Test: peri-implant probing before and after crown removal

Interventions

peri-implant probing before and after crown removal DIAGNOSTIC_TEST

Before removal of the prosthetic reconstruction: * Measurement of PPD-1: The PPDs at 6 site were measured as the distance from the mucosal margin to the base of the peri-implant pocket. * Measurement of BOP-1：Bleeding sites after gentle probing within 15s were recorded as BOP scores. A positive score (1 point) was recorded if bleeding was observed during either of probing assessment by two researchers. After removal of the prosthetic reconstruction, PPD-2 and BOP-2 were recorded following the same protocol.

patients with dental implant restorations

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

For this study, the calculation was estimated considering the peri-implantitis prevalence at implant level, thealternative the area under the receiver operating characteristic curve 0.90 , a 5% alpha error and 90% power. Thus, the minimum required sample size was 83 subjects.

You may qualify if:

• Age greater than 18 years.
• The implant has completed osseointegration and has undergone final restoration for at least one month.
• The final restoration needs to be removed or retrieved for various reasons.

You may not qualify if:

• Patients with serious systemic diseases, severe intraoral infections, severe mental disorders, pregnancy/lactation in women, or other conditions that make oral treatment operations unsuitable.
• History of crown removal or re-restoration within the past month prior to the visit.
• The prosthesis has fallen off or is severely damaged and has lost its original form before the visit.
• The prosthesis cannot be completely removed.
• Refusal to participate in this study.

Sponsors & Collaborators

• The Dental Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis; Disease

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 4, 2025
• Study Start: January 11, 2024
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

CN (1)