Gingival Recession
Conditions
Keywords
exposed Root Surface or Tooth, Tooth Sensitivity Miller Class I, Miller Class II, Gingival Margin
Brief 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.
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.
Interventions
DEVICEPuros® Dermis versus Alloderm®
Puros Dermis and Alloderm (both Allograft Tissue Matrix)
Sponsors
Zimmer Dental
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non -Inferiority of Dermis to Alloderm | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment period was from 08 25 2009 to 04 24 2011. Subjects had a single non-adjacent Miller's class I or II gingival recession defect, greater than or equal to 2mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. Subjects for this study were recruited from the PI's clinic.
Pre-assignment details
Randomized
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Puros Dermis 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.
Puros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix) | 38 |
| Group 2: 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.
Puros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix) | 42 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 |
Baseline characteristics
| Characteristic | Group 2: Alloderm | Total | Group 1: Puros Dermis |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 5 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 75 Participants | 37 Participants |
| Age, Continuous | 47.4 years STANDARD_DEVIATION 14 | 46.4 years STANDARD_DEVIATION 14.4 | 43.1 years STANDARD_DEVIATION 13.7 |
| Region of Enrollment United States | 42 participants | 80 participants | 38 participants |
| Sex: Female, Male Female | 26 Participants | 54 Participants | 28 Participants |
| Sex: Female, Male Male | 16 Participants | 26 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 38 | 0 / 42 |
| serious Total, serious adverse events | 0 / 38 | 0 / 42 |
Outcome results
Primary
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Puros Dermis | Non -Inferiority of Dermis to Alloderm | 2.06 mm | Standard Deviation 1.11 |
| Arm 2: Alloderm | Non -Inferiority of Dermis to Alloderm | 2.00 mm | Standard Deviation 0.87 |