The Study on the Accuracy of Peri-implant Probing and Related Influencing Factors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorThe Dental Hospital of Zhejiang University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
peri-implant probing before and after crown removal
Diagnostic testBefore 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.
Treatment groups
83 Participants
are divided into 1 treatment groupGroup A: patients with dental implant restorations1 intervention
Trial outcomes
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.
Time frame
On the day of enrollmentSecondary outcomes
1
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.
Time frame
On the day of enrollment2
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.
Time frame
The X-ray examination will be completed on the day of enrollment3
Emergency profile
Emergence profile was categorized as either concave, straight or convex.
Time frame
The X-ray examination will be completed on the day of enrollmentSponsors and contacts
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Source ClinicalTrials.gov