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

NCT01391767 | Completed

• 1 other identifier: Nuoss-15852
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Oral Ridge Preservation

Keywords

Ridge Preservation; Dental Implant; Histology

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  12-18 months

Study Arms (2)

NuOss XC

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

Device: NuOss XC

NuOss Particulate

Bone grafting material used in this group will be NuOss Particulate.

Interventions

NuOss XC DEVICE

NuOss XC is a bone grafting material that will be placed in extraction socket site.

NuOss XC

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Periodontal Clinic Population at the University of Oklahoma College of Dentistry

You may qualify if:

• may be either male or female
• must be between 18 and 64 years old
• must be of sufficiently good health to undergo routine dental treatment, including the surgical procedures associated with tooth extraction and placement of NuOss XC or NuOss particulate
• must agree to remain in study for 6 months after ridge preservation (grafting)
• must be able to physically, emotionally, and financially undergo the surgical and restorative (implant replacement) procedures planned.
• must not have medical conditions that preclude the removal of indicated teeth and placement of NuOss XC or NuOss particulate
• must have at least one single-rooted tooth to be extracted
• must consent to tooth extractions, socket augmentation and implant placement
• Patients with or without dental insurance

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Oklahoma: lead
• ACE Surgical Supply, Inc.: collaborator

Study Sites (1)

University of Oklahoma College of Dentistry

Oklahoma City, Oklahoma, 73126, United States

Location

Related Publications (2)

• Jemt T, Lekholm U. Implant treatment in edentulous maxillae: a 5-year follow-up report on patients with different degrees of jaw resorption. Int J Oral Maxillofac Implants. 1995 May-Jun;10(3):303-11.

  PMID: 7615326 BACKGROUND

• Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. doi: 10.1902/jop.2003.74.7.990.

  PMID: 12931761 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hard tissue histological evaluation

Study Officials

• Robert Carson, DMD, MS

  University of Oklahoma College of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 12, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 8, 2013

Record last verified: 2013-07

Locations

US (1)