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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT01628367
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged 18 or older.
* Systemically healthy (American Society of Anesthesiologists I or II).
* Subjects will have one or more anterior or premolar teeth with a hopeless prognosis, with adjacent and opposing teeth present.
* Compliance with all requirements in the study and signing the informed consent
Exclusion Criteria:
* Active acute infection at the extraction site (e.g., sinus tract, swelling)
* Absence of sufficient mesio-distal width to place an implant as per the study protocol.
* Absence of sufficient bone height to house a 10mm long implant.
* The subject lacks a stable occlusion and/or a healthy periodontium.
* Current smokers or quit smoking less than one year
* Chronic use of medications known to affect the periodontal status (calcium antagonists, anticonvulsives, immunosuppressives, anti-inflammatory medications)
* Pregnancy or lactating mothers
* Current orthodontic or periodontal treatments
* History of alcoholism or drug abuse
* Untreated deep carious lesions or defective restorations that can potentially exacerbate during the course of the study
* Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c \>7)
* Bone disorders (hyperparathyroidism, osteoporosis, or Paget's disease)
* Neurologic or psychiatric disorders, systemic infections
* A history of IV bisphosphonate use.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT01628367
Study Brief:
Protocol Section:
NCT01628367