Peri-implantitis Oral Health
Conditions
Interventions
Study participants will be randomly allocated to the test or control group during surgery, just after completing implant decontamination procedures. The randomization sequence is determined using a bl
Sponsors
Arrow Development S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Peri-implant bone defect =3 mm assessed radiographically 3. PPD =5 mm combined with bleeding on probing or suppuration 4. Intra-surgically, bone defect must have at least an intraosseous component of 3 mm and a width of no more than 4 mm 5. 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 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 using Periodontal Manual probe CP 15 Hu-Friedy at baseline, 24 and 48 weeks. Surgical assessments: 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 Periodontal Manual probe CP 15 Hu-Friedy intra-surgically. Osseous defect-related measures / recording of osseous defect characteristics: 1. Defect width (measured in mesial, distal, buccal, and palatal/lingual aspects) 2. Distance from implant neck to depth of the osseous defect (measured in mesial, distal, buccal, and palatal/lingual aspects) 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. Each included implant will be measured in mesial and distal aspects 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 in Implant-Studio® digital software in 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 o | — |
Countries
Spain
Contacts
Public ContactAlberto Ortiz-Vigón
Outcome results
None listed