Peri-implantitis at a dental implant Oral Health Peri-implantitis at a dental implant
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 or older 2. Suffering from initial to moderate peri-implantitis at an implant site 3. Presence of at least one screw-type titanium implant exhibiting signs of moderate peri-implantitis: maximum probing depth from 5 to 8 mm bleeding on probing or suppuration in at least one site, and radiographic bone loss in at least one site 4. Radiographic infraosseous component of the defect = 5mm 5. Radiographic suprabony component of the defect = 4mm 6. Presence of at least 2 mm of keratinized mucosa 7. Implant loading of at least 6 months
Exclusion criteria
Exclusion criteria: 1. Patients incapable of giving informed consent 2. Mobile implant 3. Head and neck irradiated patient 4. Chemo or immunosuppressive therapy over the previous 5 years 5. Treatment with intravenous amino-bisphosphonates 6. Poor oral hygiene and motivation 7. Untreated periodontitis 8. Uncontrolled diabetes 9. Pregnancy and lactating period 10. Substance abusers 11. Allergy to chlorhexidine or phenolic or sulfur compounds 12. Smoking more than 20 cigarettes per day, or the equivalent 13. Patients unable to attend the 3-year follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at 6-month and 3-year follow-up: 1. Implant failure. 2. Complications (including re-treatments). 3. Change in radiographic bone level is measured using periapical intraoral radiographs taken with the parallel technique at baseline, 6 months and 3 years follow-up. Reference points for the linear measurements were the coronal margin of the implant collar and the most coronal point of bone-to-implant contact. The mesial and distal sites were averaged for each implant. The radiographic measurements were relativized considering the length of the implant. The radiographs were examined by one masked examiner. 4. Change in pocket depth is measured at 4 sites of the implant (vestibular, mesial, distal and lingual) using a PCP-15 periodontal probe (Hu-Friedy) at baseline, 6 months and 3 years follow-up. 5. Change in recession depth is measured at 4 sites of the implant (vestibular, mesial, distal and lingual) using a PCP-15 periodontal probe (Hu-Friedy) at baseline, 6 months and 3 years follow-up. 6. Bleeding on probing. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain measured using VAS will be assessed immediately after the procedure, after 1 week, after 6 months, and after 3 years. 2. Satisfaction measured using VAS after 6 months and 3 years. 3. Oral health-related quality of life measured using the Oral Health Impacts Profile (OHIP-14) after 6 months and 3 years. 4. Variation in keratinized tissue (KT) is measured at mid-buccally using a PCP-15 periodontal probe at baseline, 6 months and 3 years follow-up. 5. Variation in clinical attachment level (CAL) is registered adding the values of probing depth and recession depth at baseline, 6 months and 3 years follow-up. 6. Subgingival bacterial samples will be taken immediately before debridement and at 1 month and 6 months after debridement. | — |
Countries
Italy