Peri-ImplantitisNCT07004517
The Study on the Accuracy of Peri-implant Probing and Related Influencing Factors
An observational study of Peri-Implantitis and Diagnosis, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peri-Implantitis, Diagnosis
- What is being tested?
- peri-implant probing before and after crown removal
- Type of treatment
- Pill or oral medicine
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2024to Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Misi Si, +86 186 0571 2858, misi_si@zju.edu.cn
About this study
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.
Read the detailed description
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.
- Conditions
- Peri-Implantitis, Diagnosis
- Being tested
- peri-implant probing before and after crown removal
- Medical subject headings
- Peri-Implantitis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peri-implant probing before and after crown removalDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: Diagnostic Test: peri-implant probing before and after crown removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
probing depth
The PPDs at 6 site were measured as the distance from the mucosal margin to the base of the peri-implant pocket.
Measured: On the day of enrollment
Secondary outcomes (3)
bleeding on probing
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.
Measured: On the day of enrollment
Emergency angel
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.
Measured: The X-ray examination will be completed on the day of enrollment
Emergency profile
Emergence profile was categorized as either concave, straight or convex.
Measured: The X-ray examination will be completed on the day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start11 Jan 2024
- Primary completionJun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004517
- Sponsor's protocol ID
- 2019-51
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu M, Bao S, Qian Y, Qiu C, Zhang J, Si M. Diagnostic Accuracy of Peri-Implant Probing With or Without Prostheses in Detecting Peri-Implantitis. Clin Oral Implants Res. 2026 May;37(5):612-622. doi: 10.1111/clr.70104. Epub 2026 Feb 18.
PubMed 41708887
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on the Accuracy of Peri-implant Probing and Related Influencing Factors
- ClinicalTrials.gov ID
- NCT07004517
- Acronym / sponsor ID
- 2019-51
- Conditions
- Peri-Implantitis, Diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with dental implant restorations | – | Diagnostic Test: peri-implant probing before and after crown removalConsecutive patients were selected who were treated at the Department of Oral Implantology, Stomatology Hospital, School of Medicine, Zhejiang University, Hangzhou, China, |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peri-implant probing before and after crown removalBefore 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. | Diagnostic test | patients with dental implant restorations |
Primary outcome
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.
3 secondary outcomes
bleeding on probing
Time frame: On the day of enrollment
Emergency angel
Time frame: The X-ray examination will be completed on the day of enrollment
Emergency profile
Time frame: The X-ray examination will be completed on the day of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Derived from this study: PubMed 41708887Xu M, Bao S, Qian Y, Qiu C, Zhang J, Si M. Diagnostic Accuracy of Peri-Implant Probing With or Without Prostheses in Detecting Peri-Implantitis. Clin Oral Implants Res. 2026 May;37(5):612-622. doi: 10.1111/clr.70104. Epub 2026 Feb 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implantitis and Diagnosis, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
probing depth (time frame: On the day of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07004517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.