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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-05-31

Study Completion Date

2027-07-01

Brief Summary

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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.

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Detailed Description

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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.

This 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.

The 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.

The 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.

Conditions

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Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

BioXclude Amnion Chorion Membrane

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Collagen Membrane

Intervention Type 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.

Interventions

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BioXclude Amnion Chorion Membrane

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.

Intervention Type DEVICE

Collagen Membrane

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.

Intervention Type DEVICE

Other Intervention Names

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Amnion Chorion Membrane ACM

Eligibility Criteria

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Inclusion Criteria

* 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.
* 2-3 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes