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

Bone Regeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02387008
• Other study ID #: 13-2429
• Status: Terminated
• Phase: N/A
• Start date: June 30, 2017
• Est. completion date: November 28, 2018

Study information

• Verified date: September 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: November 28, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Regeneration
• Mouth, Edentulous

Intervention

Device:
• GUIDOR® membrane with FDBA
horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA
• GUIDOR® membrane
horizontal bone augmentation with synthetic GUIDOR® membrane
• Bio-Gide® membrane with FDBA
xenograft BioGide® membrane + FDBA

Locations

Country	Name	City	State
United States	University of North Carolina School of Dentistry	Chapel Hill	North Carolina
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Sunstar Americas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	7 days, 14 days, 28 days, 6 months
Secondary	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.	7 days, 14 days, 28 days, 6 months
Secondary	Membrane Exposure	The presence of membrane exposure or soft tissue dehiscence will be visually assessed.	7 days, 14 days, 28 days, 6 months