Menu
Recruiting NCT07304752

Effect of Probe Material on Peri-implant Probing

No phase Interventional Peri-implant Health Peri-implant Mucositis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metallic UNC-15 periodontal probe, Plastic UNC-15 periodontal probe.
Who it may be relevant to
Registry conditions: Peri-implant Health, Peri-implant Mucositis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device Metallic UNC-15 periodontal probe
    Probing performed at six sites per implant with the prosthesis in place and after prosthesis removal, under standardized force (0.20 N).
  • Device Plastic UNC-15 periodontal probe
    Probing performed at six sites per implant with the prosthesis in place and after prosthesis removal, under standardized force (0.20 N).

Primary outcome measures

  • Difference in probing depth with vs. without prosthesis (ΔPS, mm) [Time frame: Baseline (single clinical visit)]
Secondary outcome measures (1)
  • Patient Discomfort During Probing (VAS, 0-100 mm) [Time frame: Immediately after probing, at the study visit]

Eligibility criteria

Inclusion criteria

  • 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)
  • Ability to understand and sign informed consent
  • Peri-implant health or mucositis, defined according to the 2017 World Workshop criteria:
  • Health: no clinical signs of inflammation, lack of profuse (line or drop) bleeding on probing, no increase in probing depth compared to previous records, and no progressive bone loss beyond initial remodeling (<2 mm). In the absence of previous radiographs, radiographic bone level <3 mm without bleeding and/or suppuration on probing.
  • Mucositis: presence of bleeding and/or suppuration on probing, no increase in probing depth compared to previous records, and no bone loss beyond initial remodeling (<2 mm). In the absence of previous radiographs, radiographic bone level <3 mm with bleeding and/or suppuration on probing.

Exclusion criteria

  • 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
  • Participation in another clinical trial within the last 30 days

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Diagnostic

Study locations

Spain · 1 center
  • Hospital Odontològic Universitat de Barcelona — L'Hospitalet de Llobregat

Identifiers

NCT: NCT07304752 · 57/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗