Peri-implant Health, Peri-implant Mucositis
Conditions
Keywords
Visual Analogue Scale, Peri-implant probing, Probing depth, Emergency profile, Dental implant
Brief summary
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.
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.
Interventions
DEVICEMetallic 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).
DEVICEPlastic 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).
Sponsors
University of Barcelona
Institut d'Investigació Biomèdica de Bellvitge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in probing depth with vs. without prosthesis (ΔPS, mm) | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Discomfort During Probing (VAS, 0-100 mm) | 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. |
Countries
Spain
Contacts
CONTACTOctavi Camps Font, DDS MS PhD
Outcome results
None listed