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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peri-implant Mucositis; Peri-implant Health
• Intervention / Treatment: Device: Metallic UNC-15 periodontal probe; Device: Plastic UNC-15 periodontal probe

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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Octavi Camps Font, DDS MS PhD; Phone Number: +34 934 024 269; Email: ocamps@ub.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metallic probe; Metallic UNC-15 periodontal probe (HuFriedy PCPUNC156)	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).
Experimental: Plastic probe; Plastic UNC-15 periodontal probe (HuFriedy PCVO12PT)	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Discomfort During Probing (VAS, 0-100 mm)	Pain/discomfort reported by the patient immediately after peri-implant probing. Unit of Measure: millimeters (0-100 mm VAS) , where 0 is the minimum pain value and 100 is the maximum pain value.	Immediately after probing, at the study visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Depth (PPD, mm)	Depth of peri-implant sulcus measured at six sites per implant using standardized probing force (20-25 g). Unit of Measure: millimeters (mm)	Baseline (single clinical visit)
Width of Keratinized Mucosa (KM, mm)	Distance from the mucosal margin to the mucogingival junction at the buccal aspect. Unit of Measure: millimeters (mm)	Baseline (single clinical visit)
Mucosal Margin Position (DIM, mm)	Distance from the mucosal margin to a fixed reference point. Unit of Measure: millimeters (mm)	Baseline (single clinical visit)
Clinical Attachment Level (CAL, mm)	Calculated as the sum of PPD and DIM. Unit of Measure: millimeters (mm)	Baseline (single clinical visit)
Modified Plaque Index (0-3 scale)	Plaque accumulation assessed according to the Modified Plaque Index (Mombelli et al., 1987). Plaque deposits around each implant will be evaluated using the Modified Plaque Index (Mombelli et al., 1987), which scores the presence of plaque or calculus on a 0-3 scale: 0 = no plaque detected; = plaque detectable only by running a probe across the marginal surface; = plaque visible to the naked eye; = abundance of soft matter or presence of calculus Unit of Measure: Units on a scale (0-3)	Baseline (single clinical visit)
Bleeding and/or Suppuration on Probing (presence/absence)	Presence or absence of bleeding and/or suppuration at each implant following the 2017 World Workshop criteria. Unit of Measure: Yes/No	Baseline (single clinical visit)
Implant Type (categorical)	Design/type of implant placed. Unit of Measure: Categorical	Baseline (single clinical visit)
Implant Position (categorical)	Specifying whether the implant was placed at bone level or tissue level Unit of Measure: Categorical .	Baseline (single clinical visit)
Implant-Prosthetic Connection Type (categorical)	The type of implant-prosthetic connection will be recorded, categorized as internal or external. Unit of Measure: Categorical	Baseline (single clinical visit)
Emergence Angle (EA, °)	The emergence angle (EA) will be measured on standardized periapical radiographs as the angle formed between: The longitudinal axis of the implant, traced as a straight line through the center of the implant body; and a tangent line to the outer surface of the prosthetic restoration at the point where the crown emerges from the implant platform. Unit of Measure: degrees (°)	Baseline (single clinical visit)
Emergence Profile (EP)	The emergence profile was recorded as a qualitative variable describing the contour of the restoration. Its classification was determined based on the emergence angle (EA): it was considered concave when EA < 30°, and convex when EA ≥ 30°. Unit of Measure: Categorical	Baseline (single clinical visit)
Connection-Contour Distance (mm)	Linear distance between implant-abutment connection and contour of the restoration. Unit of Measure: millimeters (mm)	Baseline (single clinical visit)
Prosthesis Material (type)	Material used for the prosthesis (e.g. zirconia or metal-ceramic). Unit of Measure: Categorical (material type)	Baseline (single clinical visit)
Titanium Height (mm)	This variable applies only to implants restored with zirconia crowns. The vertical height (mm) of the titanium base (Ti-base) supporting the zirconia restoration will be measured. Unit of Measure: millimeters (mm)	Baseline (single clinical visit)
Patient Satisfaction With the Procedure (VAS, 0-100 mm)	Overall satisfaction with the probing experience. Unit of Measure: millimeters (0-100 mm VAS) , where 0 is the minimum satisfaction value and 100 is the maximum satisfaction value.	Immediately after probing, at the study visit
Perceived Difficulty of Oral Hygiene (VAS, 0-100 mm)	Self-reported difficulty performing peri-implant hygiene. Unit of Measure: millimeters (0-100 mm VAS) , where 0 is the minimum difficulty performing peri-implant hygiene value and 100 is the maximum value.	Immediately after probing, at the study visit
Presence of Adverse Events (yes/no)	Presence/absence of pain, bleeding or excessive discomfort during or after probing. Unit of Measure: Yes/No	Immediately after probing, at the study visit
Peri-implant Diagnosis (health vs mucositis)	Diagnosis established based on combined PPD and BOP/SUP criteria following the 2017 World Workshop. Unit of Measure: Categorical (Health / Mucositis)	Baseline (single clinical visit)

Collaborators and Investigators

• Sponsor: University of Barcelona
• Collaborators: Institut d'Investigació Biomèdica de Bellvitge

Publications and helpful links

Helpful Links

• Hospital Odontològic Universitat de Barcelona

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Visual Analogue Scale; Dental implant; Probing depth; Peri-implant probing; Emergency profile
• Other Study ID Numbers: 57/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No