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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Roma, Italië, 00100
- George Eastman Dental Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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. |
|
Experimenteel: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Clinical attachment level
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Probing depth
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 6, 12, 18, 24 months
|
abundant bleeding evoked upon probing immediately after
|
6, 12, 18, 24 months
|
|
BOP
Tijdsspanne: 6, 12, 18, 24 months
|
bleeding upon probing: bleeding evoked upon probing after 1 second
|
6, 12, 18, 24 months
|
|
suppuration
Tijdsspanne: 6, 12, 18, 24 months
|
Binary: yes or no, detected upon probing or digital palpation
|
6, 12, 18, 24 months
|
|
Gingival thickness
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: at the surgery
|
The interval between the initial incision and placement of the final suture, measured in minutes.
|
at the surgery
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Luca Cordaro, MD, PhD, G. Eastman Dental Hospital Rome, Italy
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 18117 (Andere identificatie: City of Hope Medical Center)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .