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:
NCT00807456
Eligibility Criteria:
Inclusion Criteria:
* Provision of informed consent
* Aged 18-75 years at enrolment
* A lingual-buccal difference in bone height between 2.0-5.0 mm at the implant site
* History of edentulism in the study area of at least 3 months
* Presence of alveolar bone crest dimensions judged by the investigator to allow ≥1mm of bone circumferential to the implant after implant placement.
* In need for a single implant replacing a missing tooth in any location with an adjacent natural tooth mesially, and an adjacent natural tooth or edentulous space distally to the planned implant position (i.e. no existing or planned implant adjacent to the planned study implant position)
* Deemed by the investigator as likely to present an initially stable implant situation
Exclusion Criteria:
* Uncontrolled pathological processes in the oral cavity
* Known or suspected current malignancy
* History of radiation therapy in the head and neck region
* History of chemotherapy within 5 years prior to surgery
* Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
* Uncontrolled diabetes mellitus
* Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
* Smoking more than 10 cigarettes per day
* Present alcohol and/or drug abuse
* Current need for bone grafting in the planned implant area
* Previous enrolment in the present study
* Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months
* Involvement in the planning and conduct of the study (applies to both Sponsor staff or staff at the study site)
* Unlikely to be able to comply with study procedures, as judged by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00807456
Study Brief:
Protocol Section:
NCT00807456