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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT02387008
Eligibility Criteria:
Inclusion Criteria:
1. Provide written informed consent
2. ≥ 21 years and ≤ 75 years
3. In need of one or more implants replacing missing or non-restorable teeth in the maxilla within region 14 to 24 or the mandible within region 34 to 44
4. Edentulous for at least 6 months at study site
5. A buccal-lingual ridge width at study site of ≤ 4 mm
6. A mesial-distal distance between adjacent teeth at study site at bone level of at least 5 mm
7. A keratinized mid-buccal mucosal thickness of at least 2 mm at study site (measured buccally at MD midline from the mucogingival junction to the projected alveolar ridge crest)
8. Teeth adjacent (mesial and distal) to study site must consist of two stable, natural teeth without signs of periodontal bone loss (\> 3 mm) and/or significant soft tissue loss
9. A minimum of twenty teeth in good repair
Exclusion Criteria:
1. Insufficient interocclusal distance for implant placement and restoration at study site
2. More than 3 mm vertical bone loss at study site as measured from the mid-buccal crest of bone on the adjacent teeth
3. Previous site development (soft and/or bone tissue) performed at the study site
4. Untreated rampant caries and uncontrolled periodontal disease
5. A history within the last 6 months of the daily use of any non-cigarette tobacco products (smokeless chewing tobacco, e-cigarette, pipe or cigar smoking), or of smoking more than 10 cigarettes per day.
6. Current alcohol dependency, alcohol abuse or chemical dependency based on DSM-IV Criteria or drug abuse
7. Subjects having uncontrolled endocrine-induced diseases (e.g. uncontrolled diabetes mellitus)
8. Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
9. Use of any substance or medication that will influence bone metabolism (e.g. intravenous bisphosphonates)
10. Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
11. History of radiation in the head and neck region
12. Subject is pregnant as reported at time of enrollment
13. Unable or unwilling to return for follow-up visits for a period of 6 months
14. Unlikely to be able to comply with study procedures according to Investigators judgement
15. Previous enrollment or randomization of treatment in the present study
16. Involvement in the planning/conduct of the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT02387008
Study Brief:
Protocol Section:
NCT02387008