Bone Loss in Jaw
Conditions
Keywords
Tooth loss, Bone Resorption, Xenograft, Allograft
Brief summary
The purpose of this clinical trial is to assess if the addition of DFDBA fibers to DBBM results in greater vital bone formation than the addition of DFDBA particles to DBBM. The study team will examine the effects of the addition of DFDBA fibers to DBBM on vital bone formation. Specifically, we will assess histologically the percent vital bone formation with each of the groups during implant placement, six months after the sinus augmentation procedure. We will also evaluate the radiographic volume achieved with both groups of materials.
Detailed description
This entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. Patients needing maxillary sinus augmentation will be enrolled. There will be two subject groups in this study both of which will randomized to one of two standard care procedures. No risk or benefit is expected from being assigned to either group as both procedures are both standard care. In both groups a bone sample (core) will be obtained as a by-product of implant placement. Bone will not be extracted solely for research purposes, the bone sample attained for research will only be from bone left over after the SOC implant placement. Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.
Interventions
DEVICEDFDBA fibers
Bone Allograft fibers used in dental sinus reconstruction surgery
DEVICEDFDBA particles
Bone Allograft particles used in dental sinus reconstruction surgery
DEVICEDBBM
DBBM is routinely used in sinus augmentation to support dental implant placement and restoration of missing teeth.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Only investigators will know which material was used for the sinus lift.
Intervention model description
This is a two-independent arm, parallel-design randomized, prospective trial designed to compare two standard of care techniques
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients between age 18 and 89 * Patients needing sinus augmentation to support implant placement in the posterior maxilla * Patients must be nonsmokers, former smokers, or current smokers who smoke \<10 cigarettes per day, by self-report * Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential.
Exclusion criteria
* Patients who disclose that they will not be able to cooperate with the follow-up schedule. * Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report) * Pregnant women or women intending to become pregnant during study period * Smokers who smoke \> 10 cigarettes per day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Vital Bone Formation | Baseline to 6 months | Each side of the maxillary sinus will be used as a separate unit of analysis. The assumption is that each patient will have only one side of the maxillary sinus; however, it is common for some patients to need both maxillary sinuses augmented (2 sites in a single patient). Change in vital bone formation will be measured from baseline (surgery) to 6 months post surgery. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAngela Palaiologou-Gallis, DDS, MS
The University of Texas Health Science Center at San Antonio
Outcome results
None listed