The purpose of this study is to compare the clinical and radiographic outcomes of two different barrier membranes-amnion-chorion membranes (ACM) and conventional collagen membranes-used in guided bone regeneration (GBR) procedures for the treatment of peri-implantitis. Both membranes are commonly used in clinical practice; however, this study aims to determine whether ACM offers greater benefits in terms of peri-implant probing depth reduction, radiographic bone fill, and patient-reported post-operative healing outcomes. The findings may help inform surgical decision-making and support the use of ACM as a more effective regenerative material for managing peri-implant bony defects.
Systemically healthy adults (≥18 years) with a diagnosed peri-implantitis lesion requiring surgical intervention of any ethnicity
Comprehension of treatment plan and research project.
Presence of a single implant in function for at least one year.
Radiographic evidence of peri-implant bone loss not exceeding one-third of the implant length.
Patients who have had a history of periodontitis, diabetes, smoking habit, or have been prescribed medications that may interfere with bone healing and metabolism
Patients with allergies to any treatment devices
Patients who have a lack of keratinized mucosa (<2 mm), or positioning for implants or restorative designs that compromise oral hygiene
Peri-implant bone defects not attributable to peri-implantitis (e.g. surgical iatrogenic, trauma)
Parallel
BioXclude Amnion Chorion Membrane
DeviceA resorbable allograft membrane derived from dehydrated human amnion and chorion tissue. The membrane is placed over peri-implant bony defects during guided bone regeneration to act as a biological barrier and promote tissue healing.
Collagen Membrane
DeviceA resorbable xenograft membrane derived from porcine collagen. The membrane is placed over peri-implant bony defects during guided bone regeneration to support space maintenance and facilitate bone regeneration.
Peri-Implant Probing Depths
Mean reduction in peri-implant probing depth (in millimeters) measured using a standardized periodontal probe at six time points to assess clinical improvement following guided bone regeneration with either an amnion-chorion or collagen membrane.
Radiographic Bone Fill
Assessment of vertical bone fill (in millimeters) around the treated implant sites using standardized periapical radiographs taken at baseline and follow-up visits. Images will be analyzed using calibrated software.
PROMS
Patient-reported outcomes will be assessed using a standardized questionnaire evaluating pain, comfort, satisfaction, healing, and communication. All items are rated on a 4-point Likert-type scale: 1 = Poor, 2 = Fair, 3 = Good, 4 = Excellent. Higher scores indicate better outcomes. Two yes/no item captures presence of post-op symptoms (e.g., swelling, bleeding, comfort).
Click on the lead sponsor to view all of their trials.
Loma Linda University
Lead sponsor
Maxxeus
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
