Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institut d'Investigació Biomèdica de Bellvitge | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metallic probe | Active Comparator | Metallic UNC-15 periodontal probe (HuFriedy PCPUNC156) |
|
| Plastic probe | Experimental | Plastic UNC-15 periodontal probe (HuFriedy PCVO12PT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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) |
| 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 |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Octavi Camps Font, DDS MS PhD | Contact | +34 934 024 269 | ocamps@ub.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Odontològic Universitat de Barcelona | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
Not provided
| Label | URL |
|---|---|
| Hospital Odontològic Universitat de Barcelona | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: Informed consent updated | Nov 2, 2025 | Dec 12, 2025 | ICF_000.pdf |
Not provided
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.
Not provided
Not provided
Not provided
| 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). |
|
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
| 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) |