Histologic Evaluation of Healing Following Tooth Extraction With Ridge Preservation Using NuOss XC and NuOss Particulate

Completed

• Conditions: Oral Ridge Preservation
• Interventions: Device: NuOss XC

• Registration Number: NCT01391767
• Lead Sponsor: University of Oklahoma

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-01
• Study First Submitted QC: 2011-07-08
• Study First Posted: 2011-07-12
• Primary Completion: 2013-01
• Study Completion: 2013-05
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-05
• Last Update Posted: 2013-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

• have any requirements for antibiotic premedication for heart murmurs, artificial joints, or any other condition
• have a history of significant heart, stomach, liver, kidney, blood, immune system or other organ impairment or systemic disease that would prevent their undergoing the proposed treatment
• smoke ≥ 10 cigarettes per day or use other tobacco products
• have a religious or philosophical aversion to having processed bovine bone or collagen used in their mouth
• have taken any investigational drugs anytime in the previous month
• have dental conditions likely to require treatment, necessitating exit from the study such as deep caries, abscesses, or moderate-severe periodontal disease(s).
• have sockets that do not have four bony walls intact.
• cannot comply with treatment and follow-up visits for 6 months
• have had significant radiation exposure (occupational, therapeutic, diagnostic).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NuOss XC	NuOss XC	Bone grafting material used in this group will be NuOss XC.

Primary Outcome Measures

Name	Time	Method
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	12-18 months	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.

Trial Locations

Locations (1)

University of Oklahoma College of Dentistry; 🇺🇸 Oklahoma City, Oklahoma, United States