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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT02844569
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be adult males or females age 18 to 80 years (inclusive).
* Subjects must be able and willing to follow study procedures and instructions in English.
* Subjects must have read, understood and signed an informed consent form in English.
* Subjects must have a maxillary premolar, canine, lateral incisor, or central incisor with a restorative or periodontal hopeless prognosis (Kwok and Caton 2007), in which an implant is indicated without any sinus lift required.
* Subjects undergoing implant placement should be in adequate periodontal health prior to implant placement. This includes having probing depth ≤ 4 mm for all remaining teeth at the same quadrant of the proposed implant placement. Patients with periodontal probing sites with probing depths of up to 5 mm may also be included if bleeding on probing in these sites is absent. Each subject should be considered to be periodontally stable prior to the implant surgery.
Exclusion Criteria:
* Individuals who have a chronic disease with oral manifestations.
* Individuals who exhibit gross oral pathology.
* The use of either antibiotics or chronic use (more than 7 days) of NSAIDs within 1 month prior to screening examination.
* Individuals that require antibiotic prophylaxis prior to dental treatment.
* Chronic treatment (i.e. two weeks or more) with any medication known to affect periodontal status (e.g. phenytoin, calcium antagonists, cyclosporine, Coumadin) within 1 month prior to screening examination.
* Uncontrolled diabetes mellitus (HbA1c \>7) within 3 months prior to screening examination.
* Individual with uncontrolled parafunctional habits, such as clenching and bruxing on objects, that could adversely impact implant survival.
* Individuals with a history of intravenous bisphosphonates.
* Individuals with active infectious diseases such as hepatitis, HIV or tuberculosis.
* Current cigarette smokers.
* Individuals who are known to be pregnant, breastfeeding or planning to become pregnant within 6 months.
* Individuals with blood disorders (hemophilia) and /or currently taking anticoagulant medications, such as heparin, warfarin, or clopidogrel.
* Individuals receiving any therapy known to affect healing, such as high dose corticosteroids, radiation therapy or chemotherapy.
* Individuals allergic to topical or local anesthesia.
* Individuals who require maxillary sinus augmentation prior to dental implant therapy.
* Individuals with dehisced, fenestrated, or fractured labial/buccal alveolar bone plate determined after baseline CBCT or after tooth extraction where more than 50% of the buccal bone height is not present. In this case, if the surgeon determines that guided bone regeneration (bone graft and membrane) is needed to repair the defect, it will be done at no cost to the subject, but the subject will be excluded from the study protocol.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02844569
Study Brief:
Protocol Section:
NCT02844569