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NCT Number: NCT07304752

Effect of Probe Material on Peri-implant Probing

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.

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Key information

Conditions

Peri-Implant Health Peri-implant Mucositis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Odontològic Universitat de Barcelona

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location status: Recruiting

Location contact

Octavi Camps

CONTACT

[email protected]

+34 934 024 269

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metallic UNC-15 periodontal probe

Device

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

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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)

  2. 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)

  3. 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)

  4. Clinical Attachment Level (CAL, mm)

    Time frame: Baseline (single clinical visit)

    Calculated as the sum of PPD and DIM. Unit of Measure: millimeters (mm)

  5. 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

    • = 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)

  6. 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

  7. Implant Type (categorical)

    Time frame: Baseline (single clinical visit)

    Design/type of implant placed. Unit of Measure: Categorical

  8. 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 .

  9. 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

  10. 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 (°)

  11. 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

  12. 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)

  13. 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)

  14. 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)

  15. 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.

  16. 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.

  17. 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

  18. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Octavi Camps Font, DDS MS PhD

CONTACT

[email protected]

+34 934 024 269

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Collaborators

  • Institut d'Investigació Biomèdica de Bellvitge

Registry information

Official study title

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

Acronym: METPLA-PP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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