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

NCT02387008 | Terminated Results FDA Device

• 1 other identifier: 13-2429
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Bone Regeneration

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months after treatment

Secondary Outcomes (3)

• Inflammation

  7 days, 14 days, 28 days, 6 months

• Infection

  7 days, 14 days, 28 days, 6 months

• Membrane Exposure

  7 days, 14 days, 28 days, 6 months

Study Arms (3)

GUIDOR® membrane with FDBA

ACTIVE COMPARATOR

horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA

Device: GUIDOR® membrane with FDBA

GUIDOR® membrane alone

ACTIVE COMPARATOR

horizontal bone augmentation with synthetic GUIDOR® membrane

Device: GUIDOR® membrane

Bio-Gide® membrane with FDBA

ACTIVE COMPARATOR

xenograft BioGide® membrane + FDBA

Device: Bio-Gide® membrane with FDBA

Interventions

GUIDOR® membrane with FDBA DEVICE

horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA

GUIDOR® membrane with FDBA

GUIDOR® membrane DEVICE

horizontal bone augmentation with synthetic GUIDOR® membrane

GUIDOR® membrane alone

Bio-Gide® membrane with FDBA DEVICE

xenograft BioGide® membrane + FDBA

Bio-Gide® membrane with FDBA

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Sunstar Americas: collaborator

Study Sites (2)

University of Southern California

Los Angeles, California, 90033, United States

Location

University of North Carolina School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

Limitations and Caveats

Slow progression of recruitment and consequent enrollment of only 6 out of 60 planned participants lead to study termination and insufficient data to provide a substantive analysis. Thus data analysis was not performed.

Results Point of Contact

• Title: Gidgetta Kang
• Organization: University of North Carolina at Chapel Hill

gidget_jenkins@unc.edu

919-537-3968

Study Officials

• Ryan Cook, DDS MS

  UNC School of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: March 12, 2015
• Study Start: June 30, 2017
• Primary Completion: November 28, 2018
• Study Completion: November 28, 2018
• Last Updated: September 25, 2019
• Results First Posted: June 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)