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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT06286605
Eligibility Criteria:
Inclusion Criteria:
* Patients that required an implant supported restoration and staged horizontal guided bone regeneration (defect of class IV according to Cawed and Howell) in both mandible or maxilla.
* Patents able to understand and sign an informed consent.
* Patients were to be 18 years or older with a residual horizontal ridge thickness of 4 mm or less (Cawood-Howell Class III- IV) in the intended implant site.
* Smokers will be categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day). Only categories 1 and 2 will be included.
Exclusion Criteria:
* General contraindications to implant surgery.
* Patients irradiated in the head and neck area.
* Immunosuppressed or immunocompromised patients.
* Patients treated or under treatment with intravenous amino-bisphosphonates.
* Patients with untreated periodontitis.
* Patients with poor oral hygiene and motivation.
* Uncontrolled diabetes.
* Pregnancy or nursing.
* Substance abuser.
* Heavy smokers (smoking more than 11 cigarettes/day).
* Psychiatric problems or unrealistic expectations.
* Lack of opposite occluding dentition in the area intended for implant placement.
* Immediate implants (extractive sites will have to be healed from 6-8 weeks).
* Patients participating in other studies, if the present protocol cannot be properly adhered to.
* Patients referred only for implant placement and cannot be followed ant the treating centre.
* Patients unable to be followed for 5 years
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06286605
Study Brief:
Protocol Section:
NCT06286605