Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
64 participants
INTERVENTIONAL
2025-12-31
2026-05-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Metallic probe
Metallic UNC-15 periodontal probe (HuFriedy PCPUNC156)
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).
Plastic probe
Plastic UNC-15 periodontal probe (HuFriedy PCVO12PT)
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).
Interventions
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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).
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Institut d'Investigació Biomèdica de Bellvitge
OTHER
University of Barcelona
OTHER
Responsible Party
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Octavi Camps-Font
Associate Professor
Central Contacts
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Provided Documents
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Document Type: Informed Consent Form: Informed consent updated
Related Links
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Hospital Odontològic Universitat de Barcelona
Other Identifiers
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57/2025
Identifier Type: -
Identifier Source: org_study_id