Prospective, Comparative Assessment of Alveolar Bone Augmentation Using GUIDOR® Membrane in the Bound Edentulous Space

Not Applicable

Terminated

Interventions: Device: Bio-Gide® membrane with FDBA
Device: GUIDOR® membrane with FDBA
Device: GUIDOR® membrane

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.

Recruitment & Eligibility

Inclusion Criteria

Provide written informed consent
≥ 21 years and ≤ 75 years
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
Edentulous for at least 6 months at study site
A buccal-lingual ridge width at study site of ≤ 4 mm
A mesial-distal distance between adjacent teeth at study site at bone level of at least 5 mm
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)
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
A minimum of twenty teeth in good repair

Exclusion Criteria

Insufficient interocclusal distance for implant placement and restoration at study site
More than 3 mm vertical bone loss at study site as measured from the mid-buccal crest of bone on the adjacent teeth
Previous site development (soft and/or bone tissue) performed at the study site
Untreated rampant caries and uncontrolled periodontal disease
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.
Current alcohol dependency, alcohol abuse or chemical dependency based on DSM-IV Criteria or drug abuse
Subjects having uncontrolled endocrine-induced diseases (e.g. uncontrolled diabetes mellitus)
Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
Use of any substance or medication that will influence bone metabolism (e.g. intravenous bisphosphonates)
Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
History of radiation in the head and neck region
Subject is pregnant as reported at time of enrollment
Unable or unwilling to return for follow-up visits for a period of 6 months
Unlikely to be able to comply with study procedures according to Investigators judgement
Previous enrollment or randomization of treatment in the present study
Involvement in the planning/conduct of the study.

Arm && Interventions

Group	Intervention	Description
Bio-Gide® membrane with FDBA	Bio-Gide® membrane with FDBA	xenograft BioGide® membrane + FDBA
GUIDOR® membrane with FDBA	GUIDOR® membrane with FDBA	horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA
GUIDOR® membrane alone	GUIDOR® membrane	horizontal bone augmentation with synthetic GUIDOR® membrane

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Membrane Exposure	7 days, 14 days, 28 days, 6 months	The presence of membrane exposure or soft tissue dehiscence will be visually assessed.
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.

Locations (2): University of Southern California
🇺🇸
Los Angeles, California, United States
University of North Carolina School of Dentistry
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Chapel Hill, North Carolina, United States