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NCT Number: NCT07004517

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

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.

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Key information

Conditions

Peri-implantitis Diagnosis Disease Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Stomatognathic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Misi Si

CONTACT

[email protected]

+86 186 0571 2858

About this study

This study aims to design a diagnostic accuracy study to compare the peri-implant probing depth and bleeding on probing before and after crown removal. It will explore the impact of prosthetic design on the accuracy of peri-implant probing and its diagnostic accuracy, and provide clinical recommendations on whether the prosthesis should be removed prior to peri-implant probing.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. probing depth

    Time frame: On the day of enrollment

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

Secondary outcomes

  1. bleeding on probing

    Time frame: On the day of enrollment

    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.

  2. Emergency angel

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

    The emergence angle was calculated as the angle between the implant long axis and a line tangent to the restoration. The measurements were repeated twice, and the mean was calculated for each mesial and distal interproximal surface.

  3. Emergency profile

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

    Emergence profile was categorized as either concave, straight or convex.

Sponsors and collaborators

Lead sponsor

The Dental Hospital of Zhejiang University School of Medicine

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2025
Registry last updated
Jun 4, 2025

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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