Alveolar Ridge Defect
Conditions
Keywords
Alveolar Bone Augmentation, Implant Surgery, Guided Bone Regeneration (GBR), Guided Tissue Regeneration (GTR), Bone Graft, Periodontal Surgery
Brief 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.
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.
Interventions
DEVICECopiOs Pericardium Membrane
CopiOs Pericardium, Puros Cancellous
Sponsors
Zimmer Dental
Zimmer Biomet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 * 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).
Exclusion criteria
* 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.) * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Horizontal Ridge Widths From Baseline to 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Wound Healing Index at 6 Months | 6 months | Score Description 1. Uneventful wound healing with no gingival edema, erythema, suppuration, patient discomfort or flap dehiscence 2. Uneventful wound healing with slight gingival edema, erythema, patient discomfort or flap dehiscence but no suppuration 3. Poor wound healing with significant gingival edema, erythema, patient discomfort or flap dehiscence with suppuration |
Countries
United States
Participant flow
Recruitment details
Recruitment was from June 2009 to February 2011. Subjects were recruited from patients attenting the PI's clinic and had one edentulous site which required lateral ridge augmentation prior to dental implant placement.
Pre-assignment details
All enrolled participants took part in the study.
Participants by arm
| Arm | Count |
|---|---|
| CopiOs Pericardium 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.
CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um). | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | CopiOs Pericardium |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CopiOs Pericardium | Change in Horizontal Ridge Widths From Baseline to 6 Months | 2.61 mm | Standard Deviation 1.8 |
Secondary
Mean Wound Healing Index at 6 Months
Score Description 1. Uneventful wound healing with no gingival edema, erythema, suppuration, patient discomfort or flap dehiscence 2. Uneventful wound healing with slight gingival edema, erythema, patient discomfort or flap dehiscence but no suppuration 3. Poor wound healing with significant gingival edema, erythema, patient discomfort or flap dehiscence with suppuration
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CopiOs Pericardium | Mean Wound Healing Index at 6 Months | 1.26 units on a scale | Standard Deviation 0.44 |