Peri-Implantitis
Conditions
Brief summary
The study will aim to compare two modalities in the reconstructive treatment of peri-implantitis defects. More specifically, the control group will be a reconstructive approach (xenograft bone graft granules and collagen membrane, BioOss and BioGide, Geistlich, Wolhusen). The test group will be the same, with the exception of an autologous sub-epithelial connective tissue palatal graft, sutured beneath the flap, which will be used in addition to grafting materials. Outcomes will include CAL, PD, MR, defect resolution, PI, BoP, SUPP, surgical characteristics, and patient-reported outcome measures, including an aesthetic self-evaluation.
Detailed description
The study will aim to compare two modalities in the reconstructive treatment of peri-implantitis defects. More specifically, the control group will be a "pure" reconstructive approach (xenograft bone graft granules and resorbable collagen membrane, BioOss and BioGide, Geistlich, Wolhusen). This is in accordance with gold standard practices of reconstructive therapy of peri-implant defects. The test group will be treated with the same approach and materials, with the exception of an autologous sub-epithelial connective tissue palatal graft, sutured beneath the flap, which will be used in addition to the grafting materials. The graft will be harvested from the homolateral palate (molar region). Outcomes will include clinical attachment level (CAL; primary outcome), probing depth (PD), mucosal recession (MR), defect resolution (a composite outcome defined as the simultaneous absence of PD \> 5 mm, bleeding on probing \[BOP\] and/or suppuration \[SUP\], and bone level changes \> 0.5 mm), plaque index (PI), BOP, suppuration on probing, suppuration on palpation, surgical duration, the Early Wound Healing Index (EHI), and patient-reported outcome measures (PROMs), including aesthetic self-evaluation. PROMs will assess patients' perception of surgery, pain intensity, perceived swelling, perceived bleeding, and analgesic intake. Clinical measurements will be recorded at baseline and at 6, 12, 18, and 24 months. EHI will be assessed at 1 and 2 weeks postoperatively. Radiographic bone levels at 12 and 24 months will be compared with those recorded on radiographs obtained at baseline. All PROMs variables, as well as aesthetic self-evaluation, will be collected using specially designed questionnaires completed by the patients. PROMs data will be recorded at 4, 8, and 12 hours after surgery on the day of surgery (day 0), and daily from postoperative day 2 to day 7. Aesthetic self-evaluation will be recorded at baseline and at 6, 12, and 24 months postoperatively.
Interventions
PROCEDUREPeri-implantitis reconstructive surgery
For both arms (excluding the already included information): defect debridement, removal of debris using titanium curettes, titanium brushes on the implant surface, irrigation with saline, application of sterile cotton pellets with saline solution. Grafting with (experimental) xenograft and soft tissue, or xenograft alone (control). Suture. Specific to control group (active comparator): the peri-implant defect will be filled with xenograft, and a collagen membrane will be fitted and trimmed to the defect area. Specific to test/experimental group: same as above (for control). In addition a soft tissue graft will be harvested from the palate and sutured to the buccal flap. The entire flap will then be sutured to the lingual flap.
Sponsors
George Eastman Dental Hospital, Italy
University of Belgrade
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* · Be able and willing to provide consent and sign the informed consent form. * Be able and willing to comply with study procedures and follow-up appointments required by the study protocol. * Age\>18 years * Presence of at least one implant affected with peri-implantitis, defined as the following con-dition: at least one site presenting peri-implant probing depth (PPD) \>6 mm and simultane-ous presence of profuse BoP/SUP and a radiographically documented change in bone level greater than initial bone remodeling. In the likely event that a baseline radiographic image is absent, the bone level will be compared to where it would likely have been at the time of implant insertion and a difference of \>3 mm from that level will be considered. * Implants in function (i.e. loaded) for at least 1 year. * Screw- and cement-retained suprastructures for both fixed and removable prostheses.
Exclusion criteria
* Compromised systemic health which contraindicates the study procedures. * Pregnant or nursing women. * Cigarette smoking\>5 per day * Systemic conditions compromising healing (i.e. diabetes mellitus). Patients with diabe-tes mellitus types I or II will be asked to provide information regarding their most re-cent HbA1c values. Only patients with HbA1c\<7% will be enrolled. * Patients taking medications known to interfere with gingival or bone metabolism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level | change from baseline to: 6, 12, 18, 24 months | linear distance (mm) from the implant platform to the bottom of the pocket |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth | 6, 12, 18, 24 months | linear distance (mm) from the gingival margin to the bottom of the pocket |
| Disease resolution | 6, 12, 18, 24 months | No PD greater than or equal to 5 mm and simultaneous absence of BOP/SUP and no more than 0.5 mm change between 2 weeks and 12 and 24 months on radiograph |
| Mucosal recession | 6, 12, 18, 24 months | linear distance (mm) from the implant platform to the gingival margin |
| plaque index (minimum value 0, maximum 1) | 6, 12, 18, 24 months | binary outcome: yes/ no detected running the probe into the peri-implant sulcus |
| profuse bleeding | 6, 12, 18, 24 months | abundant bleeding evoked upon probing immediately after |
| BOP | 6, 12, 18, 24 months | bleeding upon probing: bleeding evoked upon probing after 1 second |
| suppuration | 6, 12, 18, 24 months | Binary: yes or no, detected upon probing or digital palpation |
| Gingival thickness | 6, 12, 18, 24 months | Measured in a horizontal direction at 1 mm from the gingival margin |
| PROMs - Patient perception of surgery | 4 hours, 8 hours, 12 hours, and Days 2-7 after surgery | Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate a more positive perception of the surgical procedure. |
| Radiographic bone levels | 2 weeks, 12 months, 24 months | radiographic bone level changes between the 2 week and 12 and 24 month follow-ups |
| PROMs - Patient-reported pain intensity | 4 hours, 8 hours, 12 hours, and Days 2-7 after surgery | Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate greater pain intensity. |
| PROMs - Patient-reported swelling | 4 hours, 8 hours, 12 hours, and Days 2-7 after surgery | Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate greater perceived swelling. |
| PROMs - Patient-reported bleeding | 4 hours, 8 hours, 12 hours, and Days 2-7 after surgery | Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate greater perceived bleeding. |
| PROMs - Analgesic consumption | 12 hours after surgery and daily from day 2 through day 7 after surgery | Number of analgesic tablets consumed by the patient during the first postoperative week. |
| PROMs - aesthetic self-evaluation | Baseline, 6 months, 12 months, and 24 months | Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate greater satisfaction with the esthetic outcome. |
| Early wound healing | 1 week and 2 weeks after surgery | Wound healing scores ranging from 1 to 5 by the surgeon |
| Surgical duration | at the surgery | The interval between the initial incision and placement of the final suture, measured in minutes. |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORLuca Cordaro, MD, PhD
G. Eastman Dental Hospital Rome, Italy
Outcome results
None listed