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

Sponsor
Loma Linda University
Study ID
NCT07032259
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Jan 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Amnion Chorion Membrane
    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.
  • Active Comparator: Collagen Membrane
    Participants in this group will undergo guided bone regeneration for peri-implantitis using a conventional collagen membrane as the barrier membrane during surgical treatment.

Primary Outcome Measure

Peri-Implant Probing Depths [ Time Frame: Baseline, 3, 6, 12, 18, and 24 months post-operatively ]

Central Contacts

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