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:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT00067392
Eligibility Criteria:
Inclusion Criteria:
* All patients will be willing to be present for examination two times a year for at least three years, as well as maintenance cleanings twice a year 3 months prior to the data collection visit.
* All patients will be free of uncontrolled diabetes (any type), existing malignancy, and will not be receiving any therapy that suppresses their immune system, such as radiation, chemotherapy, or chronic steroid usage
* Need for extraction of a single rooted maxillary central or lateral incisor, canine, or premolar, with no signs of acute infection (purulent exudate, erythema, pain, and swelling).
* Patients will have bone present on all surfaces of the tooth within 3 mm of the gingival margin of the planned restoration, in order to provide sufficient bone to circumferentially cover the implant.
* All patients will have adequate space for satisfactory restoration of the edentulous space.
* Each patient's dentition will be free of active periodontal disease or exhibit controllable periodontal disease such that their teeth will clinically be non-mobile and have probing depths less than 3 mm.
* All prospective sites will have at least 2mm of attached or keratinized gingiva.
* The crestal bone width should be enough to accommodate either a 3.75 diameter implant for the central incisor, canine, and premolar sites, or a 3.25 mm diameter implant for the lateral incisor tooth sites. Bone height should be at least 14 mm for accommodation of the implant.
Exclusion Criteria:
* Patients with labial dehiscence defects greater than 3 mm from the proposed gingival margin of the planned restoration will be excluded from this study.
* Patients who cannot come for follow up due to conflicts of schedules will not be accepted into the study.
* Patients with advanced cardiovascular, pulmonary, renal, liver disease that place them in an ASA III or IV rating will be excluded. Post-menopausal women with known osteoporosis as determined by their medical internist, will be excluded. Patients with known alcohol abuse will be excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Months
Maximum Age:
65 Years
Study:
NCT00067392
Study Brief:
Protocol Section:
NCT00067392