Histologic Evaluation of Healing Following Tooth Extraction With Ridge Preservation Using NuOss XC and NuOss Particulate
This study histologically evaluates sites grafted with NuOss XC using ridge preservation techniques prior to placement of dental implants. Sites grafted with NuOss XC (bovine bone mineral with self-expanding collagen) will be compared to sites grafted with NuOss particulate (bovine bone mineral).
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Histologic Evaluation of Healing Following Tooth Extraction With Ridge Preservation Using NuOss XC and NuOss Particulate|
- Histological analysis: All sections removed from the osteotomy (hole where implant will be placed) at time of implant placement to be evaluated by a single evaluator, using a semi-quantitative scoring system [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]
Histological processing: Specimens to be trimmed and embedded in methyl methacrylate (MMA). One hematoxylin and eosin (H&E) stained section, and one Goldner's trichrome-stained section to be taken from each block in a longitudinal plane through the approximate center of each defect.
Goldner's trichrome-stained slides to be scored for the presence of bone and bone marrow as a percent of the total defect area.
H&E-stained slides to be used to evaluate residual collagen and residual bone mineral as a percent of the total defect area.
Biospecimen Retention: Samples Without DNA
Hard tissue histological evaluation
|Study Start Date:||July 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Bone grafting material used in this group will be NuOss XC.
Device: NuOss XC
NuOss XC is a bone grafting material that will be placed in extraction socket site.
Bone grafting material used in this group will be NuOss Particulate.
Patients presenting to the University of Oklahoma College of Dentistry Graduate Periodontics Clinic who are treatment planned for tooth extraction and placement of dental implant(s) will be interviewed for possible participation in the study. Forty extraction sites will be included in this study to provide statistical significance.
The ridge preservation sites, using either NuOss XC or NuOss particulate, will be selected randomly. The first site will be selected using the flip of a coin. Thereafter, every other site will be grafted using NuOs XC. The ridge preservation procedure will involve tooth extraction with as little trauma as possible to preserve all four bony socket walls, curettage of the socket to remove all periodontal ligament fibers and granulation tissue, placement of the graft material into the socket and coverings the graft material with long-lasting collagen membrane. Facial and lingual mucoperiosteal flaps will be elevated to facilitate securing of the membrane with long-lasting absorbable sutures. Patient will be given prescriptions for analgesics and antibiotics as necessary.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01391767
|United States, Oklahoma|
|University of Oklahoma College of Dentistry|
|Oklahoma City, Oklahoma, United States, 73126|
|Principal Investigator:||Robert Carson, DMD, MS||University of Oklahoma College of Dentistry|