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

Primary Purpose

Bone Regeneration

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GUIDOR® membrane with FDBA
GUIDOR® membrane
Bio-Gide® membrane with FDBA
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Regeneration

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Southern California
  • University of North Carolina School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

GUIDOR® membrane with FDBA

GUIDOR® membrane alone

Bio-Gide® membrane with FDBA

Arm Description

horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA

horizontal bone augmentation with synthetic GUIDOR® membrane

xenograft BioGide® membrane + FDBA

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
Membrane Exposure
The presence of membrane exposure or soft tissue dehiscence will be visually assessed.

Full Information

First Posted
February 11, 2015
Last Updated
September 12, 2019
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Sunstar Americas
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1. Study Identification

Unique Protocol Identification Number
NCT02387008
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
This study was halted prematurely by UNC for low accrual.
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Sunstar Americas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Regeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GUIDOR® membrane with FDBA
Arm Type
Active Comparator
Arm Description
horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA
Arm Title
GUIDOR® membrane alone
Arm Type
Active Comparator
Arm Description
horizontal bone augmentation with synthetic GUIDOR® membrane
Arm Title
Bio-Gide® membrane with FDBA
Arm Type
Active Comparator
Arm Description
xenograft BioGide® membrane + FDBA
Intervention Type
Device
Intervention Name(s)
GUIDOR® membrane with FDBA
Intervention Description
horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA
Intervention Type
Device
Intervention Name(s)
GUIDOR® membrane
Intervention Description
horizontal bone augmentation with synthetic GUIDOR® membrane
Intervention Type
Device
Intervention Name(s)
Bio-Gide® membrane with FDBA
Intervention Description
xenograft BioGide® membrane + FDBA
Primary Outcome Measure Information:
Title
Dimensional Bone Changes at 6 Months
Description
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
Secondary Outcome Measure Information:
Title
Inflammation
Description
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
Title
Infection
Description
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
Title
Membrane Exposure
Description
The presence of membrane exposure or soft tissue dehiscence will be visually assessed.
Time Frame
7 days, 14 days, 28 days, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Cook, DDS MS
Organizational Affiliation
UNC School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of North Carolina School of Dentistry
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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