Effect of Probe Material on Peri-implant Probing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Barcelona
About this trial
Evaluate whether the type of probe (plastic vs. metallic) modifies the accuracy of peri-implant probing in single-unit implants, by comparing the probing depth recorded with the prosthesis in place versus without the prosthesis (ΔPD, mm). Secondarily, explore the influence of prosthetic design and implant position on probing values and on other clinical and radiographic parameters.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥18 years)
Presence of at least one single-unit bone-level implant rehabilitated with a screw-retained prosthesis directly connected to the implant (no intermediate abutment)
Implant in function for at least 1 year after prosthetic loading
No pathological bone loss on periapical radiograph (distance from the most coronal rough surface of the implant to the bone crest < 3 mm)
Disqualifiers
Cement-retained restorations or prostheses that cannot be removed
Systemic antibiotic or anti-inflammatory treatment within the previous 3 months
Pregnancy or lactation
Peri-implant treatment within the previous 3 months
Trial design
Design model
Parallel
Treatments tested in this trial
Metallic UNC-15 periodontal probe
DeviceProbing performed at six sites per implant with the prosthesis in place and after prosthesis removal, under standardized force (0.20 N).
Plastic UNC-15 periodontal probe
DeviceProbing performed at six sites per implant with the prosthesis in place and after prosthesis removal, under standardized force (0.20 N).
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Metallic probeActive comparator 1 intervention
Group B: Plastic probeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Difference in probing depth with vs. without prosthesis (ΔPS, mm)
Difference in peri-implant probing depth (ΔPS) between plastic and metallic probes, measured by a single calibrated examiner at six sites per implant using a standardized probing force (20-25 g). Unit of Measure: millimeters (mm) This primary outcome was defined following the mandatory outcome domains recommended by the international consensus on Implant Dentistry Core Outcome Set and Measurement (ID-COSM), published in the Journal of Clinical Periodontology in 2023.
Time frame
Baseline (single clinical visit)Secondary outcomes
1
Patient Discomfort During Probing (VAS, 0-100 mm)
Pain/discomfort reported by the patient immediately after peri-implant probing. Unit of Measure: millimeters (0-100 mm VAS) , where 0 is the minimum pain value and 100 is the maximum pain value.
Time frame
Immediately after probing, at the study visitOther outcomes
1
Probing Depth (PPD, mm)
Depth of peri-implant sulcus measured at six sites per implant using standardized probing force (20-25 g). Unit of Measure: millimeters (mm)
Time frame
Baseline (single clinical visit)2
Width of Keratinized Mucosa (KM, mm)
Distance from the mucosal margin to the mucogingival junction at the buccal aspect. Unit of Measure: millimeters (mm)
Time frame
Baseline (single clinical visit)3
Mucosal Margin Position (DIM, mm)
Distance from the mucosal margin to a fixed reference point. Unit of Measure: millimeters (mm)
Time frame
Baseline (single clinical visit)4
Clinical Attachment Level (CAL, mm)
Calculated as the sum of PPD and DIM. Unit of Measure: millimeters (mm)
Time frame
Baseline (single clinical visit)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Barcelona
Lead sponsor
Institut d'Investigació Biomèdica de Bellvitge
Collaborator
Source ClinicalTrials.gov