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

This study has been completed.
Sponsor:
Collaborator:
ACE Surgical Supply, Inc.
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01391767
First received: July 1, 2011
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention
Oral Ridge Preservation
Device: NuOss XC

Study Type: Observational
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

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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


Enrollment: 22
Study Start Date: July 2011
Study Completion Date: May 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NuOss XC
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.
NuOss Particulate
Bone grafting material used in this group will be NuOss Particulate.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Periodontal Clinic Population at the University of Oklahoma College of Dentistry

Criteria

INCLUSION CRITERIA:

  • 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

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391767

Locations
United States, Oklahoma
University of Oklahoma College of Dentistry
Oklahoma City, Oklahoma, United States, 73126
Sponsors and Collaborators
University of Oklahoma
ACE Surgical Supply, Inc.
Investigators
Principal Investigator: Robert Carson, DMD, MS University of Oklahoma College of Dentistry
  More Information

Publications:
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01391767     History of Changes
Other Study ID Numbers: Nuoss-15852
Study First Received: July 1, 2011
Last Updated: July 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Ridge Preservation
Dental Implant
Histology

ClinicalTrials.gov processed this record on September 22, 2014