Prospective, Comparative Assessment of Alveolar Bone Augmentation Using GUIDOR® Membrane in the Bound Edentulous Space
| Status: | Active, not recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 2/23/2019 |
| Start Date: | June 30, 2017 |
| End Date: | March 2019 |
Prospective, Comparative Assessment of Alveolar Bone Augmentation Using Guidor Membrane in the Bound Edentulous Space
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. 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.
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. 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.
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.
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