Clinical trial NCT01154868: Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation
Official title: Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Dental Implantation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2010-07-01
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 may help to rebuild bone width for dental implant placement. The ultimate goal of this study is to evaluate how this graft material can help bone healing.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: horizontal (width) bone gain or loss in millimeters.
timeFrame: 18 weeks
Secondary outcomes:
measure: radiographic bone changes measured using computer tomography
timeFrame: 18 weeks
measure: percentage of new bone formation in the alveolar bone core biopsies.
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Center for Oral Health Research
state: Michigan
Study officials:
affiliation: University of Michigan
name: William Giannobile, DDS, DMedSc
role: PRINCIPAL_INVESTIGATOR
References:
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