Gingival RecessionNCT00881959
Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®
A study testing Puros® Dermis versus Alloderm® in people with Gingival Recession, run by Zimmer Biomet at 4 sites in United States.
Trial summary
The purpose of the study is to evaluate whether clinical parameters for Puros Dermis are, at minimum, equivalent when compared to AlloDerm, the current industry standard, for the treatment of single, non-adjacent Miller's Class I or II gingival recession. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Puros® Dermis versus Alloderm®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2009to Jun 2012
- 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.
- No known allergies to study material.
- Able to communicate with the investigator and read, understand, and sign the informed consent form.
- Maxillary incisor, canine, or premolar with at least one Miller's Class I or II gingival recession defects that are not adjacent to one another.
- Depth of the gingival recession defects of 2mm or greater.
- No gingival surgery within the past 12 months at the defect site. No prior antibiotic use within 3 months with less than 2 weeks durations.
- Ability to maintain good oral hygiene.
Who cannot join
- Patients taking any medications known to cause gingival enlargement.
- Patients with unstable systemic diseases.
- Patients with compromised immune systems or unstable bleeding disorders.
- Patients with active infectious diseases (e.g. hepatitis, tuberculosis, HIV, 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.).
- Patients taking steroid medications.
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- Tobacco use or smoking within 1 year of screening visit (e.g. cigarettes, pipes, cigars, chew).
- Pregnant females or females attempting to get pregnant.
- Other conditions the investigator feels would inhibit from a good candidate for the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48109-1078
University of Alabama
Birmingham, Alabama, 35294
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, 07103-0009
University of Rochester
Rochester, New York, 14620
About this study
Official title: Multi-center, Post-market, Prospective, Randomized, Examiner-Only-Masked Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®
The purpose of the study is to evaluate whether clinical parameters for Puros Dermis are, at minimum, equivalent when compared to AlloDerm, the current industry standard, for the treatment of single, non-adjacent Miller's Class I or II gingival recession.
Read the detailed description
This is a prospective, Post-market, Randomized, Examiner-Only Masked multi-center study to evaluate whether clinical parameters for Puros Dermis are at minimum, equivalent when compared to Alloderm, the current industry standard for the treatment of single, non-adjacent Miller's Class I or II gingival recession.
- Conditions
- Gingival Recession
- Being tested
- Puros® Dermis versus Alloderm®
- Keywords
- exposed Root Surface or Tooth, Tooth Sensitivity Miller Class I, Miller Class II, Gingival Margin
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puros® Dermis versus Alloderm®Device
Also called Allograft Tissue Matrix, Human Acellular Dermal Matrix (ACDM)
Puros Dermis and Alloderm (both Allograft Tissue Matrix)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Puros Dermis | Experimental | Experimental treatment group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. Receives: Device: Puros® Dermis versus Alloderm® |
| Group 2: Alloderm | Active comparator | Control group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. Receives: Device: Puros® Dermis versus Alloderm® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non -Inferiority of Dermis to Alloderm
Non -inferiority of Dermis to Alloderm will be assessed by comparison of the average change (from the preoperative value) in gingival recession measured at 12 months between defects receiving Puros Dermis and those receiving Alloderm.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2012
- Study completionJun 2012
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 Gingival RecessionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zimmer Dental
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881959
- Sponsor's protocol ID
- 07-800
- Status last verified
- May 2015
- First submitted
- 14 Apr 2009
- Last updated
- 27 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Post-market, Prospective, Randomized, Examiner-Only-Masked Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®
- ClinicalTrials.gov ID
- NCT00881959
- Acronym / sponsor ID
- 07-800
- Conditions
- Gingival Recession
- Keywords
- exposed Root Surface or Tooth, Tooth Sensitivity Miller Class I, Miller Class II, Gingival Margin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Zimmer Dental
- Study start
- Aug 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Apr 2009 (estimated)
- Results
- Posted 27 May 2015
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 the study is to evaluate whether clinical parameters for Puros Dermis are, at minimum, equivalent when compared to AlloDerm, the current industry standard, for the treatment of single, non-adjacent Miller's Class I or II gingival recession.
Detailed description
This is a prospective, Post-market, Randomized, Examiner-Only Masked multi-center study to evaluate whether clinical parameters for Puros Dermis are at minimum, equivalent when compared to Alloderm, the current industry standard for the treatment of single, non-adjacent Miller's Class I or II gingival recession.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Puros Dermis | Experimental | Device: Puros® Dermis versus Alloderm®Experimental treatment group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. |
| Group 2: Alloderm | Active comparator | Device: Puros® Dermis versus Alloderm®Control group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, of any ethnicity, between 18 and 99 years of age.
- No known allergies to study material.
- Able to communicate with the investigator and read, understand, and sign the informed consent form.
- Maxillary incisor, canine, or premolar with at least one Miller's Class I or II gingival recession defects that are not adjacent to one another.
- Depth of the gingival recession defects of 2mm or greater.
Key exclusion criteria (9 listed)
- Patients taking any medications known to cause gingival enlargement.
- Patients with unstable systemic diseases.
- Patients with compromised immune systems or unstable bleeding disorders.
- Patients with active infectious diseases (e.g. hepatitis, tuberculosis, HIV, 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.).
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 |
|---|---|---|
| Puros® Dermis versus Alloderm®Also: Allograft Tissue Matrix, Human Acellular Dermal Matrix (ACDM)Puros Dermis and Alloderm (both Allograft Tissue Matrix) | Device | Group 1: Puros Dermis, Group 2: Alloderm |
Primary outcome
Non -Inferiority of Dermis to Alloderm
Time frame: 12 months
Non -inferiority of Dermis to Alloderm will be assessed by comparison of the average change (from the preoperative value) in gingival recession measured at 12 months between defects receiving Puros Dermis and those receiving Alloderm.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Puros® Dermis versus Alloderm® in people with Gingival Recession, 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 7 inclusion and 9 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 27 May 2015. 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 27 May 2015). 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?
Non -Inferiority of Dermis to Alloderm (time frame: 12 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 27 May 2015; AzTrials last refreshed its copy on 1 Nov 2026.