Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT01391767
Eligibility 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01391767
Study Brief:
Protocol Section:
NCT01391767