Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation
Surgical Reconstructive Treatment of Peri-Implantitis With or Without Simultaneous Soft Tissue Augmentation: a Multi-center Randomized Controlled Trial
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
-
-
-
Roma, Olaszország, 00100
- George Eastman Dental Hospital
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Aktív összehasonlító: Xenograft+collagen membrane
Reconstructive approach (Xenograft+collegen membrane)
|
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. |
|
Kísérleti: Xenograft+collagen membrane+autologous soft tissue graft
Reconstructive approach (Xenograft+collegen membrane) plus soft tissue graft (autologous, harvested as FGG)
|
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. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Clinical attachment level
Időkeret: change from baseline to: 6, 12, 18, 24 months
|
linear distance (mm) from the implant platform to the bottom of the pocket
|
change from baseline to: 6, 12, 18, 24 months
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Probing depth
Időkeret: 6, 12, 18, 24 months
|
linear distance (mm) from the gingival margin to the bottom of the pocket
|
6, 12, 18, 24 months
|
|
Disease resolution
Időkeret: 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
|
6, 12, 18, 24 months
|
|
Mucosal recession
Időkeret: 6, 12, 18, 24 months
|
linear distance (mm) from the implant platform to the gingival margin
|
6, 12, 18, 24 months
|
|
plaque index (minimum value 0, maximum 1)
Időkeret: 6, 12, 18, 24 months
|
binary outcome: yes/ no detected running the probe into the peri-implant sulcus
|
6, 12, 18, 24 months
|
|
profuse bleeding
Időkeret: 6, 12, 18, 24 months
|
abundant bleeding evoked upon probing immediately after
|
6, 12, 18, 24 months
|
|
BOP
Időkeret: 6, 12, 18, 24 months
|
bleeding upon probing: bleeding evoked upon probing after 1 second
|
6, 12, 18, 24 months
|
|
suppuration
Időkeret: 6, 12, 18, 24 months
|
Binary: yes or no, detected upon probing or digital palpation
|
6, 12, 18, 24 months
|
|
Gingival thickness
Időkeret: 6, 12, 18, 24 months
|
Measured in a horizontal direction at 1 mm from the gingival margin
|
6, 12, 18, 24 months
|
|
Radiographic bone levels
Időkeret: 2 weeks, 12 months, 24 months
|
radiographic bone level changes between the 2 week and 12 and 24 month follow-ups
|
2 weeks, 12 months, 24 months
|
|
PROMs - Patient perception of surgery
Időkeret: 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.
|
4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
|
|
PROMs - Patient-reported pain intensity
Időkeret: 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.
|
4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
|
|
PROMs - Patient-reported swelling
Időkeret: 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.
|
4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
|
|
PROMs - Patient-reported bleeding
Időkeret: 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.
|
4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
|
|
PROMs - Analgesic consumption
Időkeret: 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.
|
12 hours after surgery and daily from day 2 through day 7 after surgery
|
|
PROMs - aesthetic self-evaluation
Időkeret: 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.
|
Baseline, 6 months, 12 months, and 24 months
|
|
Early wound healing
Időkeret: 1 week and 2 weeks after surgery
|
Wound healing scores ranging from 1 to 5 by the surgeon
|
1 week and 2 weeks after surgery
|
|
Surgical duration
Időkeret: at the surgery
|
The interval between the initial incision and placement of the final suture, measured in minutes.
|
at the surgery
|
Együttműködők és nyomozók
Együttműködők
Nyomozók
- Kutatásvezető: Luca Cordaro, MD, PhD, G. Eastman Dental Hospital Rome, Italy
Publikációk és hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 18117 (Egyéb azonosító: City of Hope Medical Center)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .