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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT01871220
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or greater
* Subjects requiring replacement of a single-rooted tooth in the maxillary arch from first premolar to first premolar with an implant-supported restoration
* Teeth adjacent (mesial and distal) to study site must consist of two stable, natural teeth without signs of periodontal bone loss (\<2.0mm) and/or significant soft tissue loss
* An opposing dentition with teeth, implants, or fixed prosthesis
* Subjects must be willing to follow instructions related to the study procedures
* Subjects must have read, understood, and signed the informed consent document
Exclusion Criteria:
Exclusion Criteria:
* Insufficient interocclusal space for implant placement and/or restoration at study site
* More than 2.0mm vertical bone loss at study site as measured from the mid-buccal crest of the bone on the adjacent teeth
* Untreated rampant caries
* Tobacco use free for ≤ 6 months
* Liver or kidney disfunction/failure
* Active severe infectious diseases that may affect normal healing and/or bone metabolism (e.g. AIDS)
* Uncontrolled diabetes
* Current alcohol or drug abuse
* Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
* History of relevant head/neck cancer and/or radiation of the head/neck
* Subjects who currently use bisphosphonates or have a history of bisphosphonate use
* Subjects with metabolic bone diseases such as osteoporosis or Paget's disease of bone
* Known pregnancy or nursing mothers
* Unable or unwilling to return for follow-up visits for a period of 1 year
* Unlikely to be able to comply with study procedures according to investigators judgement
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01871220
Study Brief:
Protocol Section:
NCT01871220