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Effect of Probe Material on Peri-implant Probing (METPLA-PP)

U

University of Barcelona

Status

Not yet enrolling

Conditions

Peri-implant Health
Peri-implant Mucositis

Treatments

Device: Metallic UNC-15 periodontal probe
Device: Plastic UNC-15 periodontal probe

Study type

Interventional

Funder types

Other

Identifiers

NCT07304752
57/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

64 participants in 2 patient groups

Metallic probe
Active Comparator group
Description:
Metallic UNC-15 periodontal probe (HuFriedy PCPUNC156)
Treatment:
Device: Metallic UNC-15 periodontal probe
Plastic probe
Experimental group
Description:
Plastic UNC-15 periodontal probe (HuFriedy PCVO12PT)
Treatment:
Device: Plastic UNC-15 periodontal probe

Trial documents
1

Trial contacts and locations

0

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Central trial contact

Octavi Camps Font, DDS MS PhD

Data sourced from clinicaltrials.gov

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