Advanced peri-implantitis Oral Health
Conditions
Interventions
The project will be conducted as a prospective cohort study of 1-year duration in 1 clinical center. 20 systemically healthy patients with implants =1 year in function and diagnosed with advanced peri
Sponsors
Arrow Development S.L.
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Aged =18 years old 2. Peri-implant bone defect =3 mm assessed radiographically 3. PPD =5 mm combined with bleeding on probing or suppuration 4. Intra-surgically, the bone defect must have at least an intraosseous component of 3 mm and a width of no more than 4mm implants =1 year in function
Exclusion criteria
Exclusion criteria: 1. Treated for peri-implantitis during the previous 6 months 2. Intake of systemic or local antibiotics during the previous 6 months 3. Pregnant patients 4. Systemically unhealthy patients 5. Patients allergic to collagen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success will be defined as the absence of bleeding on probing (BoP)/pus, probing pocket depth (PPD) =5 mm and =1 mm recession measured using a periodontal manual probe CP 15 Hu-Friedy at 4, 12, 24 and 48 weeks after surgical therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical assessments: One calibrated examiner will perform the assessments. The following variables will be assessed at four sites around the implant: Plaque, probing pocket depth (PPD), bleeding on probing (BoP), probing attachment level (PAL) recession (REC). Keratinized mucosa (KM) will be measured in the buccal aspect of each included implant measured using a periodontal manual probe CP 15 Hu-Friedy at baseline, 24 and 48 weeks Surgical assessments: 1. Defect configuration will be measured by one calibrated examiner in each clinical center to understand how much impact it has on clinical outcomes measured using a periodontal manual probe CP 15 Hu-Friedy at intra-surgically: 2. Osseous defect-related measures / Recording of osseous defect characteristics: 2.1. Defect width (measured in mesial, distal, buccal, and palatal/lingual aspects) 2.2. Distance from implant neck to depth of the osseous defect (measured in mesial, distal, buccal, and palatal/lingual aspects) 2.3. Distance from osseous ridge to depth of the osseous defect (measured in mesial, distal, buccal, and palatal/lingual aspects) Radiographic assessments: Radiographic marginal bone level in mesial and distal aspects measured in mm with Image-J® digital software using intra-oral radiographs obtained before surgery (baseline) and at 6- and 12-month re-examinations. Analysis of radiographs will be performed by a specialist. The examiner will be blinded to treatment procedures. The assessment will include defect fill in both follow-up visits. Volumetric changes: Linear changes measured using Implant-Studio® digital software at 1, 3 and 5 mm from the mucosal peri-implant margin. Intra-oral scanning will be obtained before surgery (baseline) at 6 months and 12 months of re-examination. Analysis of STL archives will be performed by a specialist. The examiner will be blinded to treatment procedures. The assessment will include volumetric changes after matching the baseline intra-oral scanning, 6 months of | — |
Countries
Spain
Contacts
Public Contacterik Regidor
Outcome results
None listed