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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT00820235
Eligibility Criteria:
Inclusion Criteria:
* Provision of informed consent
* At least 18 years
* In need of one or more single implants replacing missing or non-restorable teeth in the maxilla within region 14 to 24
The following should be considered at inclusion but can not be fulfilled until at Visit 2:
* Edentulous for at least 5 months at study site
* A buccal-lingual bone width at study site of at least 5.5 mm
* A mesial-distal bone level distance between adjacent teeth at study site of at least 5.5 mm
* A keratinized mid-buccal mucosal height of at least 2 mm at study site
* Teeth adjacent (mesial and distal) to study site must consist of two stable teeth on natural roots without signs of periodontal bone loss (\>1 mm) and/or significant soft tissue loss
* Teeth adjacent (mesial and distal) to study site must demonstrate a stable occlusal guidance that will allow non-functional disclusion in all eccentric positions
* An opposing dentition with teeth, implants or prosthesis
Exclusion Criteria:
* Insufficient interocclusal distance for implant placement and restoration at study site
* Tooth adjacent (mesial and/or distal) to study site is ankylosed
* More than 2 mm vertical bone loss at study site as measured from the mid-buccal crest of bone on the adjacent teeth
* Site development (bone tissue) performed at less than 5 months before Visit 2 at study site
* Untreated rampant caries and/or uncontrolled periodontal disease
* Class II division 2 malocclusion (Edward Hartley Angle)
* Use of tobacco within last 6 months
* Uncontrolled diabetes (subjects history does not reveal the absence of control of insulin-dependent/non-insulin dependent Diabetes Mellitus)
* Current alcohol or drug abuse
* Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
* Use of any substance that will influence bone metabolism
* Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
* History of radiation in the head and neck region
* Known pregnancy, pregnancy tests will be performed as per local requirements.
* Unable or unwilling to return for follow-up visits for a period of 5 years
* Unlikely to be able to comply with study procedures according to Investigators judgement
* Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study center)
* Previous enrollment or randomization of treatment in the present study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00820235
Study Brief:
Protocol Section:
NCT00820235