Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-01-06 @ 1:46 PM
Study NCT ID:
NCT07032259
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regenerative Outcomes for Peri-implant Bony Defects Using Amnion-chorion Barrier vs. Collagen Membrane
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This means the patient and the evaluator collecting outcome data (probing, PROMs, radiographs) are blinded. The only one that will not be blinded will be the surgeon.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Number of Study Arms/Groups:\n\nThe study includes two arms:\n\n1. Test Group: Patients receiving amnion-chorion membrane (ACM) during GBR treatment.\n2. Control Group: Patients receiving a standard collagen membrane during GBR treatment.\n\n * Study Center:\n\nThis is a single-center study conducted at Loma Linda University School of Dentistry, Center for Implant Dentistry.\n\n* Study Agents / Interventions:\n\n * Test Intervention: Amnion-chorion membrane (ACM) - dehydrated human placental tissue used as a biologically active resorbable barrier.\n * Control Intervention: Collagen membrane - a conventional resorbable membrane used in GBR procedures.\n* Changes in Scheduling or Dosing:\n\nNo dose escalation or multiple dosing is involved. Both membranes are used locally, applied during a single surgical procedure. Follow-up evaluations will occur at 3, 6, 12, 18, and 24 months postoperatively.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-06-19', 'studyFirstSubmitQcDate': '2025-06-19', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peri-Implant Probing Depths', 'timeFrame': 'Baseline, 3, 6, 12, 18, and 24 months post-operatively', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Radiographic Bone Fill', 'timeFrame': 'Over 2 years', 'description': '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.'}, {'measure': 'PROMS', 'timeFrame': 'Baseline, 3, 6, 12, 18, and 24 months post-operatively', 'description': 'Patient-reported outcomes will be assessed using a standardized questionnaire evaluating pain, comfort, satisfaction, healing, and communication.\n\nAll items are rated on a 4-point Likert-type scale:\n\n1 = 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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peri-implantitis'], 'conditions': ['Peri-Implantitis']}, 'referencesModule': {'references': [{'pmid': '36935269', 'type': 'RESULT', 'citation': 'Sadowsky SJ. Peri-implantitis after 40 years: Evidence, mechanisms, and implications: A mapping review. J Prosthet Dent. 2024 Dec;132(6):1215-1225. doi: 10.1016/j.prosdent.2023.02.008. Epub 2023 Mar 17.'}, {'pmid': '31087457', 'type': 'RESULT', 'citation': 'Monje A, Pons R, Insua A, Nart J, Wang HL, Schwarz F. Morphology and severity of peri-implantitis bone defects. Clin Implant Dent Relat Res. 2019 Aug;21(4):635-643. doi: 10.1111/cid.12791. Epub 2019 May 14.'}, {'pmid': '36017594', 'type': 'RESULT', 'citation': 'Baima G, Citterio F, Romandini M, Romano F, Mariani GM, Buduneli N, Aimetti M. Surface decontamination protocols for surgical treatment of peri-implantitis: A systematic review with meta-analysis. Clin Oral Implants Res. 2022 Nov;33(11):1069-1086. doi: 10.1111/clr.13992. Epub 2022 Sep 7.'}, {'pmid': '35472107', 'type': 'RESULT', 'citation': 'Bhide VM, Goldberg MB, Tenenbaum HC. Surgical Treatment of Peri-implantitis with Guided Bone Regeneration Using Dehydrated Amnion-Chorion Membranes: A Case Report with a 2-Year Follow-up. Int J Periodontics Restorative Dent. 2022 May-Jun;42(3):e59-e66. doi: 10.11607/prd.5633.'}, {'pmid': '34547066', 'type': 'RESULT', 'citation': 'Miller RJ, Korn RJ, Miller RJ. The Use of a Dehydrated, Deepithelialized Amnion-Chorion Membrane in Guided Bone Regeneration Involving Staged Implant Placement: Case Series with a 5-Year Follow-up. Int J Periodontics Restorative Dent. 2021 Sep-Oct;41(5):657-662. doi: 10.11607/prd.5602.'}, {'pmid': '29926484', 'type': 'RESULT', 'citation': 'Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Clin Periodontol. 2018 Jun;45 Suppl 20:S246-S266. doi: 10.1111/jcpe.12954.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Peri-implantitis is a common complication characterized by inflammation and progressive bone loss around dental implants. Guided bone regeneration (GBR) is a frequently employed surgical approach to manage peri-implant defects. Barrier membranes play a critical role in GBR by excluding soft tissue and supporting bone regeneration.\n\nThis randomized controlled clinical trial is designed to compare the outcomes of two commonly used barrier membranes: amnion-chorion membranes (ACM) and conventional collagen membranes. Although both are used in practice, ACM may offer additional biological benefits due to the presence of growth factors, anti-inflammatory properties, and native extracellular matrix components.\n\nThe study will enroll 56 participants across four clinical sites, with subjects randomly assigned to receive either ACM or a collagen membrane during peri-implant GBR surgery. Clinical parameters, including probing depths and peri-implant soft tissue health, will be recorded at baseline and follow-up visits. Patient-reported outcome measures (PROMs) will be collected using standardized questionnaires to evaluate post-operative healing, discomfort, and satisfaction. Standardized periapical radiographs will be taken at 3, 6, 12, 18, and 24 months to assess radiographic bone fill.\n\nThe primary objective is to determine whether the use of ACM results in improved clinical and radiographic outcomes compared to collagen membranes. Secondary objectives include evaluating patient-reported healing and long-term implant stability. Results from this study may inform clinical decision-making and potentially support the wider use of ACM in regenerative peri-implant therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Systemically healthy adults (≥18 years) with a diagnosed peri-implantitis lesion requiring surgical intervention of any ethnicity\n* Comprehension of treatment plan and research project.\n* Presence of a single implant in function for at least one year.\n* Radiographic evidence of peri-implant bone loss not exceeding one-third of the implant length.\n* 2-3 wall defects amenable to guided bone regeneration (GBR).\n* Screw-retained, posterior, self-cleansing implant prosthesis.\n* Commitment to maintaining oral hygiene and attending follow-up visits.\n\nExclusion Criteria:\n\n* Patients who have had a history of periodontitis, diabetes, smoking habit, or have been prescribed medications that may interfere with bone healing and metabolism\n* Patients with allergies to any treatment devices\n* Patients who have a lack of keratinized mucosa (\\<2 mm), or positioning for implants or restorative designs that compromise oral hygiene\n* Peri-implant bone defects not attributable to peri-implantitis (e.g. surgical iatrogenic, trauma)\n* Anterior implant restorations (#'s 6-11, #'s 22-27) or cement-retained restorations"}, 'identificationModule': {'nctId': 'NCT07032259', 'briefTitle': 'Regenerative Outcomes for Peri-implant Bony Defects Using Amnion-chorion Barrier vs. Collagen Membrane', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Regenerative Outcomes for Peri-implant Bony Defects Using Amnion-chorion Barrier vs. Collagen Membrane: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '5250224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amnion Chorion Membrane', 'description': 'Participants in this group will undergo guided bone regeneration for peri-implantitis using an amnion-chorion membrane (ACM) as the barrier membrane during surgical treatment.', 'interventionNames': ['Device: BioXclude Amnion Chorion Membrane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Collagen Membrane', 'description': 'Participants in this group will undergo guided bone regeneration for peri-implantitis using a conventional collagen membrane as the barrier membrane during surgical treatment.', 'interventionNames': ['Device: Collagen Membrane']}], 'interventions': [{'name': 'BioXclude Amnion Chorion Membrane', 'type': 'DEVICE', 'otherNames': ['Amnion Chorion Membrane', 'ACM'], 'description': 'A 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.', 'armGroupLabels': ['Amnion Chorion Membrane']}, {'name': 'Collagen Membrane', 'type': 'DEVICE', 'description': 'A 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.', 'armGroupLabels': ['Collagen Membrane']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Brandon Kim', 'role': 'CONTACT', 'email': 'Bykim1@students.llu.edu', 'phone': '805-305-0826'}, {'name': 'Jaime Lozada', 'role': 'CONTACT', 'email': 'JLozada@llu.edu', 'phone': '909-558-4980'}], 'overallOfficials': [{'name': 'Jaime Lozada', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department Chair'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maxxeus', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}