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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT02931968
Eligibility Criteria:
Inclusion Criteria
* 18 years and older
* Good physical health (American Society of Anesthesiologist classification I (ASA I) and II (ASA II) to undergo routine comprehensive recall examination
1. ASA I - A normal healthy patient
2. ASA II - A patient with mild systemic health.
* Able to give informed consent
* At least one edentulous arch (maxilla and/or mandible) that were treatment planned and restored with full arch MZISFDP by UNC Graduate Prosthodontic clinic and/or UNC Dental Faculty Practice between January 1, 2008- September 1, 2015
* Pregnancy status during the time of recall
1. Women of non-childbearing potential - defined as those who have no uterus, ligation of the fallopian tubes, or permanent cessation of ovarian function due to ovarian failure or surgical removal of the ovaries (i.e. permanently sterilized, postmenopausal). Postmenopausal is defined as 12 months with no menses without an alternative medical cause "Non-childbearing potential" status will be determined with a questionnaire.
2. Women of childbearing potential - Female patient who don't fulfill the "non-childbearing potential" status will be considered of childbearing potential. Status of pregnancy will be determined by administering urine pregnancy tests If a subject is found to be pregnant and they consent to remaining in the study then any data from the intraoral exam will be included and the subject will be excluded from the radiographic examination.
Exclusion Criteria
* History of radiotherapy in the head and neck region
* History of intravenous bisphosphonate therapy
* Medical conditions that contraindicate elective dental therapy and routine recall appointment
* American Society of Anesthesiologist Classification III (ASA III), IV (ASA IV), V (ASA V) and VI (ASA VI)
1. ASA III - a patient with severe systemic disease
2. ASA IV -a patient with severe systemic disease that is a constant threat to life.
3. ASA V - a moribund patient who is not expected to survive without the operation.
4. ASA VI - a declared brain-dead patient whose organs are being removed for donor purposes.
* Psychological and/or behavioral conditions that make routine recall appointments very difficult to impossible
* Known alcohol and/or drug abuse
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02931968
Study Brief:
Protocol Section:
NCT02931968