Clinical trial NCT02387008: Prospective, Comparative Assessment of Alveolar Bone Augmentation Using GUIDOR® Membrane in the Bound Edentulous Space
Official title: Prospective, Comparative Assessment of Alveolar Bone Augmentation Using Guidor Membrane in the Bound Edentulous Space
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bone Regeneration
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Sunstar Americas
First posted: 2015-03-12
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dimensional Bone Changes at 6 Months
timeFrame: 6 months after treatment
Secondary outcomes:
measure: Inflammation
timeFrame: 7 days, 14 days, 28 days, 6 months
measure: Infection
timeFrame: 7 days, 14 days, 28 days, 6 months
measure: Membrane Exposure
timeFrame: 7 days, 14 days, 28 days, 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Chapel Hill
country: United States
facility: University of North Carolina School of Dentistry
state: North Carolina
Study officials:
affiliation: UNC School of Dentistry
name: Ryan Cook, DDS MS
role: PRINCIPAL_INVESTIGATOR
References: