Localized Alveolar Ridge Augmentation With Space Maintenance Devices (NCT00991432) | Clinical Trial Compass
TerminatedNot Applicable
Localized Alveolar Ridge Augmentation With Space Maintenance Devices
United States10 participantsStarted 2009-10
Plain-language summary
The purpose of this research study is to determine whether this study treatment can improve the bone structure of the upper front part of the jaw in patients who are scheduled for surgery to have a dental implant(s) placed into the upper front part of their mouths and need to have more bone in their jaws to support the implant, so that a dental implant can later be inserted.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able to provide written informed consent
. ≥ 18 years
. Scheduled for dental implant into anterior maxillary alveolar ridge
. Negative urine pregnancy test for patients of child bearing potential and agreement not to become pregnant for at least 12 months after surgery
. Able to comply with all study-related procedures, including exercising good oral hygiene
. A prosthodontic treatment plan has been drafted.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Alveolar ridge bone formation sufficient to place endosseous implants
. Known hypersensitivity to rhBMP-2, bovine Type I collagen or other components of the formulation
. Known hypersensitivity to titanium
. Operative site is in the area of a resected or extant tumor
. Any active malignancy or current treatment for a malignancy
. Active infection at operative site
. History of prior exposure to rhBMP-2/ACS
. Received and failed a previous alveolar ridge augmentation procedure
. Pathology that would either compromise a bone grafting procedure, or interfere with obtaining quantitative measurements from postoperative computer tomography scans