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

NCT ID: NCT02387008

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2018-11-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GUIDOR® membrane with FDBA

horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA

Group Type: ACTIVE_COMPARATOR

GUIDOR® membrane with FDBA

Intervention Type: DEVICE

horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA

GUIDOR® membrane alone

horizontal bone augmentation with synthetic GUIDOR® membrane

Group Type: ACTIVE_COMPARATOR

GUIDOR® membrane

Intervention Type: DEVICE

horizontal bone augmentation with synthetic GUIDOR® membrane

Bio-Gide® membrane with FDBA

xenograft BioGide® membrane + FDBA

Group Type: ACTIVE_COMPARATOR

Bio-Gide® membrane with FDBA

Intervention Type: DEVICE

xenograft BioGide® membrane + FDBA

Interventions

GUIDOR® membrane with FDBA

horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA

Intervention Type: DEVICE

GUIDOR® membrane

horizontal bone augmentation with synthetic GUIDOR® membrane

Intervention Type: DEVICE

Bio-Gide® membrane with FDBA

xenograft BioGide® membrane + FDBA

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunstar Americas

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Cook, DDS MS

Role: PRINCIPAL_INVESTIGATOR

UNC School of Dentistry

Locations

University of Southern California

Los Angeles, California, United States

University of North Carolina School of Dentistry

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

13-2429

Identifier Type: -

Identifier Source: org_study_id