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

University of Oklahoma (OU)

Status

Completed

Conditions

Oral Ridge Preservation

Treatments

Device: NuOss XC

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT01391767

Nuoss-15852

Details and patient eligibility

About

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).

Full 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.

Enrollment

22 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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).