Peri-ImplantitisNCT07032259
Regenerative Outcomes for Peri-implant Bony Defects Using Amnion-chorion Barrier vs. Collagen Membrane
A study testing BioXclude Amnion Chorion Membrane and Collagen Membrane in people with Peri-Implantitis, run by Loma Linda University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- BioXclude Amnion Chorion Membrane and Collagen Membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Regenerative Outcomes for Peri-implant Bony Defects Using Amnion-chorion Barrier vs. Collagen Membrane: a Randomized Controlled Clinical Trial
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.
Read the detailed description
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
- Peri-Implantitis
- Being tested
- BioXclude Amnion Chorion Membrane, Collagen Membrane
- Keywords
- Peri-implantitis
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioXclude Amnion Chorion MembraneDevice
Also called Amnion Chorion Membrane, ACM
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 MembraneDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Collagen Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3, 6, 12, 18, and 24 months post-operatively
Secondary outcomes (2)
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.
Measured: Over 2 years
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).
Measured: Baseline, 3, 6, 12, 18, and 24 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Maxxeus
- Responsible party
- Sponsor
- Investigators
- Jaime Lozada, Principal investigator, Department Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032259
- Sponsor's protocol ID
- 5250224
- Status last verified
- Jul 2026
- First submitted
- 19 Jun 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36935269Monje 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.
PubMed 31087457Baima 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.
PubMed 36017594Bhide 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.
PubMed 35472107Miller 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.
PubMed 34547066Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Clin Periodontol. 2018 Jun;45 Suppl 20:S246-S266. doi: 10.1111/jcpe.12954.
PubMed 29926484
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Outcomes for Peri-implant Bony Defects Using Amnion-chorion Barrier vs. Collagen Membrane: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07032259
- Acronym / sponsor ID
- 5250224
- Conditions
- Peri-Implantitis
- Keywords
- Peri-implantitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Maxxeus
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Amnion Chorion Membrane | Experimental | Device: BioXclude Amnion Chorion MembraneParticipants in this group will undergo guided bone regeneration for peri-implantitis using an amnion-chorion membrane (ACM) as the barrier membrane during surgical treatment. |
| Collagen Membrane | Active comparator | Device: Collagen MembraneParticipants in this group will undergo guided bone regeneration for peri-implantitis using a conventional collagen membrane as the barrier membrane during surgical treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioXclude Amnion Chorion MembraneAlso: Amnion Chorion Membrane, ACMA 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. | Device | Amnion Chorion Membrane |
| Collagen MembraneA 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. | Device | Collagen Membrane |
Primary outcome
Peri-Implant Probing Depths
Time frame: Baseline, 3, 6, 12, 18, and 24 months post-operatively
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.
2 secondary outcomes
Radiographic Bone Fill
Time frame: Over 2 years
PROMS
Time frame: Baseline, 3, 6, 12, 18, and 24 months post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Results publication: PubMed 36935269Sadowsky 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.
- Results publication: PubMed 31087457Monje 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.
- Results publication: PubMed 36017594Baima 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.
- Results publication: PubMed 35472107Bhide 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.
- Results publication: PubMed 34547066Miller 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.
- Results publication: PubMed 29926484Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Clin Periodontol. 2018 Jun;45 Suppl 20:S246-S266. doi: 10.1111/jcpe.12954.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaime Lozada principal investigator
Department Chair
Questions about this trial
What is this clinical trial studying?
A study testing BioXclude Amnion Chorion Membrane and Collagen Membrane in people with Peri-Implantitis, run by Loma Linda University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandon Kim (805-305-0826, Bykim1@students.llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-Implant Probing Depths (time frame: Baseline, 3, 6, 12, 18, and 24 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07032259, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.