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Not Yet RecruitingNCT07304752

Effect of Probe Material on Peri-implant Probing

Effect of Probe Material (Metallic vs. Plastic) on Peri-implant Probing: a Randomized Clinical Trial.

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
64 (estimated)
Sponsor
University of Barcelona · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

Randomized clinical trial with two parallel groups. Eligible patients will be randomized (1:1 ratio) to one of two parallel treatment groups: Group 1 (Metal probe): Peri-implant probing performed with a UNC-15 metallic periodontal probe (HuFriedy PCPUNC156). Group 2 (Plastic probe): Peri-implant probing performed with a UNC-15 plastic periodontal probe (HuFriedy PCVO12PT). Primary objective: To 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 (ΔPS, mm). Secondary objectives: To explore the influence of prosthetic design (e.g., emergence profile, crown contour) and implant position on probing depth values and other clinical/radiographic parameters. To evaluate patient-reported discomfort during peri-implant probing, recorded using a 100-mm visual analogue scale (VAS). The study was designed in accordance with the international consensus on Implant Dentistry Core Outcome Set and Measurement (ID-COSM), published in the Journal of Clinical Periodontology in 2023. The protocol includes all applicable mandatory outcome domains recommended by this consensus for implant dentistry clinical trials.

Conditions

Interventions

TypeNameDescription
DEVICEMetallic UNC-15 periodontal probeProbing performed at six sites per implant with the prosthesis in place and after prosthesis removal, under standardized force (0.20 N).
DEVICEPlastic UNC-15 periodontal probeProbing performed at six sites per implant with the prosthesis in place and after prosthesis removal, under standardized force (0.20 N).

Timeline

Start date
2025-12-01
Primary completion
2026-05-01
Completion
2026-05-01
First posted
2025-12-26
Last updated
2025-12-26

Source: ClinicalTrials.gov record NCT07304752. Inclusion in this directory is not an endorsement.