Alveolar Ridge DefectNCT00889265
CopiOs® Pericardium Membrane for Localized Alveolar Ridge Augmentation
A study testing CopiOs Pericardium Membrane in people with Alveolar Ridge Defect, run by Zimmer Biomet at 4 sites in United States.
Trial summary
This is a prospective, multi-center study to evaluate the use of CopiOs Pericardium Membrane, a bovine xenograft, with use of Puros Cancellous Particulate Allograft, for the augmentation of localized alveolar ridge defects on either the maxilla or mandible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Ridge Defect
- What is being tested?
- CopiOs Pericardium Membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, of any ethnicity, between 18 and 99 years of age
- Health status of P1(ASA I) or P2 (ASA II), as classified by the American Academy of Anesthesiologists
- Able to communicate with the investigator and read, understand, and sign the informed consent form
- No evidence of active moderate or severe periodontitis
- Must be available for multiple follow-up visits for the duration of the study
- The study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5 mm in its smallest buccolingual dimension as measured by ridge-mapping calipers (#RIDGE-CALIPER, Salvin Dental Specialties, Inc., Charlotte, NC).
Who cannot join
- Inability or failure to maintain adequate oral hygiene
- Women who are bread-feeding, pregnant, or who intend to become pregnant during this study period. Women of childbearing potential should be practicing a medically accepted method of birth control
- Patients with unstable systemic diseases
- Patients with compromised immune system (e.g. uncontrolled diabetes, etc.) or unstable bleeding disorder
- Patients with active infectious diseases (e.g. hepatitis, tuberculosis, HEV, etc.)
- Patients with a mental disability that may hinder participation in the study (e.g. inability to follow through with oral hygiene instructions, postoperative instructions, follow-up commitments, etc.)
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- Patients taking steroid medications or undergoing other immunosuppressive therapy
- Radiation, cancer therapy, and/or radiation specifically at the oral cavity within the last 6 months
- History of previous ridge augmentation at the site of interest
- Augmentation sites with localized pathology
- Patient who has participated in a clinical trial within 30 days of being enrolled in this study, is currently enrolled in another study, or plans to enroll in another study before the completion of of this study.
- Unresolved oral pathologies (e.g. periodontal disease, caries, etc.)
- Medications or conditions contraindicated for bone regeneration: methotrexate, corticosteroids, history of bisphosphonate use, cyclosporine-A, etc.
- Patients who have more than a minimal tobacco use (e.g. >10 cigarettes per day)
- Other conditions the investigator may feel would inhibit the patient from being a good candidate for this study or which are contraindicated in the Directions for Use.
- Note: Careful consideration should be given to alternative therapies prior to performing bone grafting in patients who have severe endocrine-induced bone diseases (e.g.hyperparathyroidism), or who are undergoing current therapy with drugs that intervene in calcium metabolism.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Colorado Denver School of Dental Medicine
Aurora, Colorado, 80045
University of Texas Health Sciences Center at Houston
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, 78229-3900
About this study
Official title: Prospective, Multi-Center Study of CopiOs® Pericardium Membrane With Puros® Cancellous Particulate Allograft for Localized Alveolar Ridge Augmentation
This is a prospective, multi-center study to evaluate the use of CopiOs Pericardium Membrane, a bovine xenograft, with use of Puros Cancellous Particulate Allograft, for the augmentation of localized alveolar ridge defects on either the maxilla or mandible.
Read the detailed description
The study will evaluate the use of CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft, with the use of Puros Cancellous Particulate Allograft (Puros Cancellous), a mineralized allograft, for the augmentation of localized alveolar ridge defects in edentulous sites. The purpose of the study will be to determine placement time, ease of use, stability, esthetics and to clinically evaluate the efficacy of the list products. A biopsy will be taken from a subset of the patient population, at one investigational site, to evaluate the grafted site's formation of new bone. The study hypothesis is that if CopiOs Pericardium and Puros Cancellous are used, the a single, localized alveolar ridge defect will clinically improve at an edentulous site.
- Conditions
- Alveolar Ridge Defect
- Being tested
- CopiOs Pericardium Membrane
- Keywords
- Alveolar Bone Augmentation, Implant Surgery, Guided Bone Regeneration (GBR), Guided Tissue Regeneration (GTR), Bone Graft, Periodontal Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CopiOs Pericardium MembraneDevice
Also called Pericardium Membrane, Bovine Xenograft, Cancellous Particulate, Human Allograft
CopiOs Pericardium, Puros Cancellous
| Study group | Role | What they receive |
|---|---|---|
| CopiOs Pericardium Membrane | Experimental | Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers. Receives: Device: CopiOs Pericardium Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Horizontal Ridge Widths From Baseline to 6 Months
The primary outcome measure of the study was the average change in ridge width from baseline (pre operative/pre grafting) to 6 months post surgery. The ridge measurements were taken using ridge mapping calipers and recorded for each patient at baseline and 6 months. Baseline measurements were taken at the site of greatest ridge width deficiency as determined by the investigator and repeated at the same location for subsequent measurements. A radiographic template with a radiopaque foil was utilized to standardize clinical and radiographic measurements for each patient.
Measured: 6 months
Secondary outcomes (1)
Mean Wound Healing Index at 6 Months
Score Description
- Uneventful wound healing with no gingival edema, erythema, suppuration, patient discomfort or flap dehiscence
- Uneventful wound healing with slight gingival edema, erythema, patient discomfort or flap dehiscence but no suppuration
- Poor wound healing with significant gingival edema, erythema, patient discomfort or flap dehiscence with suppuration
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alveolar Ridge DefectStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zimmer Dental
- Responsible party
- Sponsor
- Investigators
- Brian Mealy, Principal investigator, University of Texas Health Sciences Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889265
- Sponsor's protocol ID
- 07-801
- Status last verified
- Aug 2014
- First submitted
- 26 Apr 2009
- Last updated
- 11 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center Study of CopiOs® Pericardium Membrane With Puros® Cancellous Particulate Allograft for Localized Alveolar Ridge Augmentation
- ClinicalTrials.gov ID
- NCT00889265
- Acronym / sponsor ID
- 07-801
- Conditions
- Alveolar Ridge Defect
- Keywords
- Alveolar Bone Augmentation, Implant Surgery, Guided Bone Regeneration (GBR), Guided Tissue Regeneration (GTR), Bone Graft, Periodontal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Zimmer Dental
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Posted 7 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center study to evaluate the use of CopiOs Pericardium Membrane, a bovine xenograft, with use of Puros Cancellous Particulate Allograft, for the augmentation of localized alveolar ridge defects on either the maxilla or mandible.
Detailed description
The study will evaluate the use of CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft, with the use of Puros Cancellous Particulate Allograft (Puros Cancellous), a mineralized allograft, for the augmentation of localized alveolar ridge defects in edentulous sites. The purpose of the study will be to determine placement time, ease of use, stability, esthetics and to clinically evaluate the efficacy of the list products. A biopsy will be taken from a subset of the patient population, at one investigational site, to evaluate the grafted site's formation of new bone. The study hypothesis is that if CopiOs Pericardium and Puros Cancellous are used, the a single, localized alveolar ridge defect will clinically improve at an edentulous site.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CopiOs Pericardium Membrane | Experimental | Device: CopiOs Pericardium MembraneSubject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, of any ethnicity, between 18 and 99 years of age
- Health status of P1(ASA I) or P2 (ASA II), as classified by the American Academy of Anesthesiologists
- Able to communicate with the investigator and read, understand, and sign the informed consent form
- No evidence of active moderate or severe periodontitis
- Must be available for multiple follow-up visits for the duration of the study
Key exclusion criteria (16 listed)
- Inability or failure to maintain adequate oral hygiene
- Women who are bread-feeding, pregnant, or who intend to become pregnant during this study period. Women of childbearing potential should be practicing a medically accepted method of birth control
- Patients with unstable systemic diseases
- Patients with compromised immune system (e.g. uncontrolled diabetes, etc.) or unstable bleeding disorder
- Patients with active infectious diseases (e.g. hepatitis, tuberculosis, HEV, etc.)
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 |
|---|---|---|
| CopiOs Pericardium MembraneAlso: Pericardium Membrane, Bovine Xenograft, Cancellous Particulate, Human AllograftCopiOs Pericardium, Puros Cancellous | Device | CopiOs Pericardium Membrane |
Primary outcome
Change in Horizontal Ridge Widths From Baseline to 6 Months
Time frame: 6 months
The primary outcome measure of the study was the average change in ridge width from baseline (pre operative/pre grafting) to 6 months post surgery. The ridge measurements were taken using ridge mapping calipers and recorded for each patient at baseline and 6 months. Baseline measurements were taken at the site of greatest ridge width deficiency as determined by the investigator and repeated at the same location for subsequent measurements. A radiographic template with a radiopaque foil was utilized to standardize clinical and radiographic measurements for each patient.
1 secondary outcome
Mean Wound Healing Index at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Orofacial Clefts, Cleft Lip and Palate
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Vestibular Versus Trapezoid Flap in Immediate Implants
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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. This study is not recruiting at the moment.
Brian Mealy principal investigator
University of Texas Health Sciences Center at San Antonio
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CopiOs Pericardium Membrane in people with Alveolar Ridge Defect, run by Zimmer Biomet at 4 sites in United States.
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 6 inclusion and 16 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: finished, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 7 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Horizontal Ridge Widths From Baseline to 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2014; AzTrials last refreshed its copy on 1 Nov 2026.