Regenerative Outcomes for Peri-implant Bony Defects Using Amnion-chorion Barrier vs. Collagen Membrane

NCT07032259 | Not Yet Recruiting

• 1 other identifier: 5250224
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peri-Implantitis

Keywords

Peri-implantitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3, 6, 12, 18, and 24 months post-operatively

Secondary Outcomes (2)

• Radiographic Bone Fill

  Over 2 years

• PROMS

  Baseline, 3, 6, 12, 18, and 24 months post-operatively

Study Arms (2)

Amnion Chorion Membrane

EXPERIMENTAL

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.

Device: BioXclude Amnion Chorion Membrane

Collagen Membrane

ACTIVE COMPARATOR

Participants in this group will undergo guided bone regeneration for peri-implantitis using a conventional collagen membrane as the barrier membrane during surgical treatment.

Device: Collagen Membrane

Interventions

BioXclude Amnion Chorion Membrane DEVICE

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.

Also known as: Amnion Chorion Membrane, ACM

Amnion Chorion Membrane

Collagen Membrane DEVICE

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.

Collagen Membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• wall defects amenable to guided bone regeneration (GBR).
• Screw-retained, posterior, self-cleansing implant prosthesis.
• Commitment to maintaining oral hygiene and attending follow-up visits.

You may not qualify if:

• 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)
• Anterior implant restorations (#'s 6-11, #'s 22-27) or cement-retained restorations

Sponsors & Collaborators

• Loma Linda University: lead
• Maxxeus: collaborator

Related Publications (6)

• 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: 36935269 RESULT

• 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: 31087457 RESULT

• 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: 36017594 RESULT

• 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: 35472107 RESULT

• 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: 34547066 RESULT

• 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.

  PMID: 29926484 RESULT

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jaime Lozada

  Department Chair

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandon Kim

CONTACT

805-305-0826; Bykim1@students.llu.edu

Jaime Lozada

CONTACT

909-558-4980; JLozada@llu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Number of Study Arms/Groups: The study includes two arms: 1. Test Group: Patients receiving amnion-chorion membrane (ACM) during GBR treatment. 2. Control Group: Patients receiving a standard collagen membrane during GBR treatment. * Study Center: This is a single-center study conducted at Loma Linda University School of Dentistry, Center for Implant Dentistry. * Study Agents / Interventions: * Test Intervention: Amnion-chorion membrane (ACM) - dehydrated human placental tissue used as a biologically active resorbable barrier. * Control Intervention: Collagen membrane - a conventional resorbable membrane used in GBR procedures. * Changes in Scheduling or Dosing: No 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.

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 22, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share