Status:
WITHDRAWN
Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation
Lead Sponsor:
William Giannobile
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Dental Implantation
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to document and evaluate how a bone graft material (Healos®) can help rebuild bone width. Dental implants can only be placed when enough bone is found and this bone graft ...
Eligibility Criteria
Inclusion
- age 21 and older
- 2-4 ADJACENT maxillary front teeth missing
- require ridge augmentation and dental implant
- nonsmoker for at least 6 months
- willing to follow oral hygiene instruction and other study instruction
- able to read, understand and sign informed consent
Exclusion
- Residual upper jaw bone equal to or narrower than 3mm.
- Insufficient gum tissue to obtain wound closure after surgery.
- Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth; or other kidney, liver, heart, thyroid, blood, autoimmune or acute infectious diseases that makes interpretation of the data more difficult
- A history of head \& neck radiation treatment due to certain medical conditions.
- Taking steroids, tetracycline or tetracycline analogs, bone therapeutic levels of fluorides, bisphosphonates, medications affecting bone turnover, antibiotics for \>7 days or any investigational drug
- Pregnancy or become pregnant during the length of the study
- Wearing removable partial dentures that may put pressure over the area where the bone graft will be placed.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01154868
Start Date
August 1 2010
End Date
February 1 2011
Last Update
December 14 2015
Active Locations (1)
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1
Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106