Bone Regeneration
Conditions
Brief summary
Purpose: The goal of guided bone augmentation is to provide an alveolar ridge of sufficient dimension to permit dental implant placement. While a wide variety of bone graft and barrier membrane products are commercially available, limited evidence exists supporting the use of one technique over another. The purpose of this study is to radiographically define the dimensional bone changes following horizontal bone augmentation using a synthetic GUIDOR® (Sunstar, Inc.) membrane. Secondary outcome measurements will include the assessment of inflammation, infection, or other wound healing complications. Participants: A total of 60 patients requiring bone augmentation of a single bound edentulous site prior to dental implant placement will be selected for this study. This is a multicenter study with 30 patients receiving treatment at each study site. Procedures (methods): Patients will be randomly allocated to receive horizontal bone augmentation with synthetic GUIDOR® membrane + freeze dried bone augmentation (FDBA), synthetic GUIDOR® membrane alone, or xenograft BioGide® membrane + FDBA. Cone beam computed tomography (CBCT) imaging will be obtained at baseline and 6 months post-operatively to assess dimensional alveolar ridge changes. Additionally, post-operative appointments at 1, 2, and 4 weeks post-grafting will be completed to assess the presence of inflammation, infection, wound dehiscence, or membrane exposure.
Interventions
DEVICEGUIDOR® membrane with FDBA
horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA
DEVICEGUIDOR® membrane
horizontal bone augmentation with synthetic GUIDOR® membrane
DEVICEBio-Gide® membrane with FDBA
xenograft BioGide® membrane + FDBA
Sponsors
Sunstar Americas
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provide written informed consent 2. ≥ 21 years and ≤ 75 years 3. In need of one or more implants replacing missing or non-restorable teeth in the maxilla within region 14 to 24 or the mandible within region 34 to 44 4. Edentulous for at least 6 months at study site 5. A buccal-lingual ridge width at study site of ≤ 4 mm 6. A mesial-distal distance between adjacent teeth at study site at bone level of at least 5 mm 7. A keratinized mid-buccal mucosal thickness of at least 2 mm at study site (measured buccally at MD midline from the mucogingival junction to the projected alveolar ridge crest) 8. Teeth adjacent (mesial and distal) to study site must consist of two stable, natural teeth without signs of periodontal bone loss (\> 3 mm) and/or significant soft tissue loss 9. A minimum of twenty teeth in good repair
Exclusion criteria
1. Insufficient interocclusal distance for implant placement and restoration at study site 2. More than 3 mm vertical bone loss at study site as measured from the mid-buccal crest of bone on the adjacent teeth 3. Previous site development (soft and/or bone tissue) performed at the study site 4. Untreated rampant caries and uncontrolled periodontal disease 5. A history within the last 6 months of the daily use of any non-cigarette tobacco products (smokeless chewing tobacco, e-cigarette, pipe or cigar smoking), or of smoking more than 10 cigarettes per day. 6. Current alcohol dependency, alcohol abuse or chemical dependency based on DSM-IV Criteria or drug abuse 7. Subjects having uncontrolled endocrine-induced diseases (e.g. uncontrolled diabetes mellitus) 8. Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration 9. Use of any substance or medication that will influence bone metabolism (e.g. intravenous bisphosphonates) 10. Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration 11. History of radiation in the head and neck region 12. Subject is pregnant as reported at time of enrollment 13. Unable or unwilling to return for follow-up visits for a period of 6 months 14. Unlikely to be able to comply with study procedures according to Investigators judgement 15. Previous enrollment or randomization of treatment in the present study 16. Involvement in the planning/conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dimensional Bone Changes at 6 Months | 6 months after treatment | Dimensional bone changes will assessed by calculating horizontal width and vertical height changes using data from DICOM images acquired by Cone beam computed tomography (CBCT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation | 7 days, 14 days, 28 days, 6 months | The presence or absence of soft tissue erythema within 3 mm from the crestal incision in the edentulous site will be visually assessed at post-operative evaluations. |
| Infection | 7 days, 14 days, 28 days, 6 months | The presence or absence of infection in the area of ridge augmentation will be assessed through visual evaluation and palpation. The presence of suppuration from the crestal incision or soft tissues adjacent to the localized ridge augmentation will be assessed through visual evaluation. Fluctuance in the area of the augmentation will be assessed through gentle palpation of the surgical site. |
| Membrane Exposure | 7 days, 14 days, 28 days, 6 months | The presence of membrane exposure or soft tissue dehiscence will be visually assessed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GUIDOR® Membrane With FDBA Horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA
GUIDOR® membrane with FDBA: horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA | 2 |
| GUIDOR® Membrane Alone Horizontal bone augmentation with synthetic GUIDOR® membrane
GUIDOR® membrane: horizontal bone augmentation with synthetic GUIDOR® membrane | 0 |
| Bio-Gide® Membrane With FDBA Xenograft BioGide® membrane + FDBA
Bio-Gide® membrane with FDBA: xenograft BioGide® membrane + FDBA | 4 |
| Total | 6 |
Baseline characteristics
| Characteristic | GUIDOR® Membrane With FDBA | Bio-Gide® Membrane With FDBA | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 6 Participants |
| Region of Enrollment United States | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 0 | 0 / 4 |
| other Total, other adverse events | 0 / 2 | 0 / 0 | 0 / 4 |
| serious Total, serious adverse events | 0 / 2 | 0 / 0 | 0 / 4 |
Outcome results
Primary
Dimensional Bone Changes at 6 Months
Dimensional bone changes will assessed by calculating horizontal width and vertical height changes using data from DICOM images acquired by Cone beam computed tomography (CBCT).
Time frame: 6 months after treatment
Population: Protocol-defined collection intervals were not achieved for any subjects enrolled; therefore, no data available for this measure.
Secondary
Infection
The presence or absence of infection in the area of ridge augmentation will be assessed through visual evaluation and palpation. The presence of suppuration from the crestal incision or soft tissues adjacent to the localized ridge augmentation will be assessed through visual evaluation. Fluctuance in the area of the augmentation will be assessed through gentle palpation of the surgical site.
Time frame: 7 days, 14 days, 28 days, 6 months
Population: No participants were randomized to the GUIDOR® Membrane Alone Arm
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GUIDOR® Membrane With FDBA | Infection | Infection present | 0 Participants |
| GUIDOR® Membrane With FDBA | Infection | Infection absent | 2 Participants |
| GUIDOR® Membrane Alone | Infection | Infection present | 0 Participants |
| GUIDOR® Membrane Alone | Infection | Infection absent | 0 Participants |
| Bio-Gide® Membrane With FDBA | Infection | Infection present | 0 Participants |
| Bio-Gide® Membrane With FDBA | Infection | Infection absent | 4 Participants |
Secondary
Inflammation
The presence or absence of soft tissue erythema within 3 mm from the crestal incision in the edentulous site will be visually assessed at post-operative evaluations.
Time frame: 7 days, 14 days, 28 days, 6 months
Population: No participants were randomized to the GUIDOR® Membrane Alone Arm
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GUIDOR® Membrane With FDBA | Inflammation | Inflammation Absent | 2 Participants |
| GUIDOR® Membrane With FDBA | Inflammation | Inflammation Present | 0 Participants |
| GUIDOR® Membrane Alone | Inflammation | Inflammation Present | 0 Participants |
| GUIDOR® Membrane Alone | Inflammation | Inflammation Absent | 0 Participants |
| Bio-Gide® Membrane With FDBA | Inflammation | Inflammation Present | 0 Participants |
| Bio-Gide® Membrane With FDBA | Inflammation | Inflammation Absent | 4 Participants |
Secondary
Membrane Exposure
The presence of membrane exposure or soft tissue dehiscence will be visually assessed.
Time frame: 7 days, 14 days, 28 days, 6 months
Population: No participants were randomized to the GUIDOR® Membrane Alone Arm
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GUIDOR® Membrane With FDBA | Membrane Exposure | membrane exposure or soft tissue dehiscencePresent | 0 Participants |
| GUIDOR® Membrane With FDBA | Membrane Exposure | membrane exposure or soft tissue dehiscence Absent | 2 Participants |
| GUIDOR® Membrane Alone | Membrane Exposure | membrane exposure or soft tissue dehiscencePresent | 0 Participants |
| GUIDOR® Membrane Alone | Membrane Exposure | membrane exposure or soft tissue dehiscence Absent | 0 Participants |
| Bio-Gide® Membrane With FDBA | Membrane Exposure | membrane exposure or soft tissue dehiscencePresent | 0 Participants |
| Bio-Gide® Membrane With FDBA | Membrane Exposure | membrane exposure or soft tissue dehiscence Absent | 4 Participants |