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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT05166434
Eligibility Criteria:
Inclusion Criteria:
* Patients with edentulous vertically deficient posterior maxillary ridge a minimum 4 mm height of alveolar bone, and 6 mm in width.
* Both males as well as females without any active periodontal disease.
* All patients are in a good health with no systemic, immunologic or debilitating diseases that could affect normal bone healing.
* All selected patients are non-smokers and non-alcoholics.
* Patients are free from T.M.J troubles, abnormal oral habits such as bruxism.
* The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.
* Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.
Exclusion Criteria:
1. On the local level, patients with maxillary sinus diseases, former sinus surgery and unfavorable inter maxillary relationship will be excluded.
2. General contraindications to implant surgery.
3. Subjected to irradiation in the head and neck area less than 1 year before implantation.
4. Untreated periodontitis.
5. Poor oral hygiene and motivation.
6. Uncontrolled diabetes.
7. Pregnant or nursing.
8. Substance abuse.
9. Psychiatric problems or unrealistic expectations.
10. Severe bruxism or clenching.
11. Immunosuppressed or immunocompromised.
12. Treated or under treatment with intravenous amino-bisphosphonates.
13. Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
14. Active infection or severe inflammation in the area intended for implant placement.
15. Need of bone augmentation procedures at implant placement.
16. Unable to open mouth sufficiently to accommodate the surgical tooling.
17. Patients participating in other studies, if the present protocol could not be properly followed.
18. Referred only for implant placement or unable to attend a 5-year follow-up.
19. Requiring only single implant-supported crowns.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05166434
Study Brief:
Protocol Section:
NCT05166434