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

December 12, 2025 updated by: Octavi Camps-Font, University of Barcelona

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Octavi Camps Font, DDS MS PhD
  • Phone Number: +34 934 024 269
  • Email: ocamps@ub.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in probing depth with vs. without prosthesis (ΔPS, mm)
Time Frame: Baseline (single clinical visit)

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Discomfort During Probing (VAS, 0-100 mm)
Time Frame: Immediately after probing, at the study visit
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Probing Depth (PPD, mm)
Time Frame: Baseline (single clinical visit)
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)
Time Frame: Baseline (single clinical visit)

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)
Time Frame: Baseline (single clinical visit)
Distance from the mucosal margin to a fixed reference point. Unit of Measure: millimeters (mm)
Baseline (single clinical visit)
Clinical Attachment Level (CAL, mm)
Time Frame: Baseline (single clinical visit)
Calculated as the sum of PPD and DIM. Unit of Measure: millimeters (mm)
Baseline (single clinical visit)
Modified Plaque Index (0-3 scale)
Time Frame: Baseline (single clinical visit)

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

  1. = plaque detectable only by running a probe across the marginal surface
  2. = plaque visible to the naked eye
  3. = 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)
Time Frame: Baseline (single clinical visit)

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)
Time Frame: Baseline (single clinical visit)
Design/type of implant placed. Unit of Measure: Categorical
Baseline (single clinical visit)
Implant Position (categorical)
Time Frame: Baseline (single clinical visit)
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)
Time Frame: Baseline (single clinical visit)

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, °)
Time Frame: Baseline (single clinical visit)

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)
Time Frame: Baseline (single clinical visit)

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)
Time Frame: Baseline (single clinical visit)

Linear distance between implant-abutment connection and contour of the restoration.

Unit of Measure: millimeters (mm)
Baseline (single clinical visit)
Prosthesis Material (type)
Time Frame: Baseline (single clinical visit)
Material used for the prosthesis (e.g. zirconia or metal-ceramic). Unit of Measure: Categorical (material type)
Baseline (single clinical visit)
Titanium Height (mm)
Time Frame: Baseline (single clinical visit)

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)
Time Frame: Immediately after probing, at the study visit
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)
Time Frame: Immediately after probing, at the study visit
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)
Time Frame: Immediately after probing, at the study visit
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)
Time Frame: Baseline (single clinical visit)

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Barcelona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut d'Investigació Biomèdica de Bellvitge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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