Bone RegenerationNCT02387008
Prospective, Comparative Assessment of Alveolar Bone Augmentation Using GUIDOR® Membrane in the Bound Edentulous Space
A study testing GUIDOR® membrane with FDBA, GUIDOR® membrane and Bio-Gide® membrane with FDBA in people with Bone Regeneration, run by University of North Carolina, Chapel Hill at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Regeneration
- What is being tested?
- GUIDOR® membrane with FDBA, GUIDOR® membrane and Bio-Gide® membrane with FDBA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jun 2017to 28 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina School of Dentistry
Chapel Hill, North Carolina, 27599
University of Southern California
Los Angeles, California, 90033
About this study
Official title: Prospective, Comparative Assessment of Alveolar Bone Augmentation Using Guidor Membrane in the Bound Edentulous Space
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
- Being tested
- GUIDOR® membrane with FDBA, GUIDOR® membrane, Bio-Gide® membrane with FDBA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GUIDOR® membrane with FDBADevice
horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA
GUIDOR® membraneDevice
horizontal bone augmentation with synthetic GUIDOR® membrane
Bio-Gide® membrane with FDBADevice
xenograft BioGide® membrane + FDBA
| Study group | Role | What they receive |
|---|---|---|
| GUIDOR® membrane with FDBA | Active comparator | horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA Receives: Device: GUIDOR® membrane with FDBA |
| GUIDOR® membrane alone | Active comparator | horizontal bone augmentation with synthetic GUIDOR® membrane Receives: Device: GUIDOR® membrane |
| Bio-Gide® membrane with FDBA | Active comparator | xenograft BioGide® membrane + FDBA Receives: Device: Bio-Gide® membrane with FDBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months after treatment
Secondary outcomes (3)
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.
Measured: 7 days, 14 days, 28 days, 6 months
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.
Measured: 7 days, 14 days, 28 days, 6 months
Membrane Exposure
The presence of membrane exposure or soft tissue dehiscence will be visually assessed.
Measured: 7 days, 14 days, 28 days, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study start30 Jun 2017
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
Why it stopped: This study was halted prematurely by UNC for low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone RegenerationStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Sunstar Americas
- Responsible party
- Sponsor
- Investigators
- Ryan Cook, DDS MS, Principal investigator, UNC School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387008
- Sponsor's protocol ID
- 13-2429
- Status last verified
- Sep 2019
- First submitted
- 11 Feb 2015
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Comparative Assessment of Alveolar Bone Augmentation Using Guidor Membrane in the Bound Edentulous Space
- ClinicalTrials.gov ID
- NCT02387008
- Acronym / sponsor ID
- 13-2429
- Conditions
- Bone Regeneration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was halted prematurely by UNC for low accrual.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Sunstar Americas
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 12 Mar 2015 (estimated)
- Results
- Posted 19 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GUIDOR® membrane with FDBA | Active comparator | Device: GUIDOR® membrane with FDBAhorizontal bone augmentation with synthetic GUIDOR® membrane + FDBA |
| GUIDOR® membrane alone | Active comparator | Device: GUIDOR® membranehorizontal bone augmentation with synthetic GUIDOR® membrane |
| Bio-Gide® membrane with FDBA | Active comparator | Device: Bio-Gide® membrane with FDBAxenograft BioGide® membrane + FDBA |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GUIDOR® membrane with FDBAhorizontal bone augmentation with synthetic GUIDOR® membrane + FDBA | Device | GUIDOR® membrane with FDBA |
| GUIDOR® membranehorizontal bone augmentation with synthetic GUIDOR® membrane | Device | GUIDOR® membrane alone |
| Bio-Gide® membrane with FDBAxenograft BioGide® membrane + FDBA | Device | Bio-Gide® membrane with FDBA |
Primary outcome
Dimensional Bone Changes at 6 Months
Time frame: 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).
3 secondary outcomes
Inflammation
Time frame: 7 days, 14 days, 28 days, 6 months
Infection
Time frame: 7 days, 14 days, 28 days, 6 months
Membrane Exposure
Time frame: 7 days, 14 days, 28 days, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Bone Regeneration
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Alveolar Bone Regeneration, Advanced Platelet-Rich Fibrin
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruitingObservational study
Impact of Gingival Phenotype on Guided Bone Regeneration in the Maxillary Anterior Region
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Clinical Efficacy Assessment of Digitally Fabricated PEEK Barrier Membranes for Guided Bone Regeneration in Severe Bone Defects
Guided Bone Regeneration
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Cook, DDS MS principal investigator
UNC School of Dentistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GUIDOR® membrane with FDBA, GUIDOR® membrane and Bio-Gide® membrane with FDBA in people with Bone Regeneration, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dimensional Bone Changes at 6 Months (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.