NCT07304752

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

November 16, 2025

Last Update Submit

December 12, 2025

Conditions

Peri-implant MucositisPeri-implant Health

Keywords

Visual Analogue ScalePeri-implant probingProbing depthEmergency profileDental implant

Outcome Measures

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.

    Baseline (single clinical visit)

Secondary Outcomes (1)

  • Patient Discomfort During Probing (VAS, 0-100 mm)

    Immediately after probing, at the study visit

Other Outcomes (18)

  • Probing Depth (PPD, mm)

    Baseline (single clinical visit)

  • Width of Keratinized Mucosa (KM, mm)

    Baseline (single clinical visit)

  • Mucosal Margin Position (DIM, mm)

    Baseline (single clinical visit)

  • +15 more other outcomes

Study Arms (2)

Metallic probe

ACTIVE COMPARATOR

Metallic UNC-15 periodontal probe (HuFriedy PCPUNC156)

Device: Metallic UNC-15 periodontal probe

Plastic probe

EXPERIMENTAL

Plastic UNC-15 periodontal probe (HuFriedy PCVO12PT)

Device: Plastic UNC-15 periodontal probe

Interventions

Metallic UNC-15 periodontal probeDEVICE

Probing performed at six sites per implant with the prosthesis in place and after prosthesis removal, under standardized force (0.20 N).

Metallic probe
Plastic UNC-15 periodontal probeDEVICE

Probing performed at six sites per implant with the prosthesis in place and after prosthesis removal, under standardized force (0.20 N).

Plastic probe

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Central Study Contacts

Octavi Camps Font, DDS MS PhD

CONTACT

+34 934 024 269ocamps@ub.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: All clinical measurements will be performed by a single examiner previously trained and calibrated for peri-implant probing in order to ensure consistency and minimize measurement error.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 16, 2025

First Posted

December 26, 2025

Study Start

December 1, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share