Health Condition 1: null- Completely edentulous maxillae with severe bone loss
Conditions
Interventions
Intervention1: Zygomatic Implant: Branemark System Zygoma Ti-Unite Implants RP from Nobel Biocare Gothenburg Sweden) having the following lengths: 30, 35, 40, 42.5, 45, 47.5, 50 and 52.5 mm
Control In
Sponsors
Dr Gunaseelan Rajan
Dr B Praveen
Eligibility
Inclusion criteria
Inclusion criteria: Patients with fully edentulous and atrophic maxilla not having sufficient bone volumes for placing dental implants at all or when it is possible to place only 2 implants in the front area (minimal diameter 3.5 mm and length of 8 mm) as evaluated on TC scans. No more than 4 mm of bone height should be available subantrally.
Exclusion criteria
Exclusion criteria: General contraindications to implant surgery such as Patient irradiated in the head and neck region with greater than 70 Gray. Immunosuppressed or immunocompromised patients. Patients who took or are taking amino-bisphosphonates intravenously. Patients with poor oral hygiene and motivation. Patients with untreated periodontitis. Uncontrolled diabetes. Pregnancy or lactation. Addiction to alcohol or drugs. Psychiatric problems. Lack of opposite occluding dentition or prosthesis. Restricted mouth opening of less than 3.5 cm inter-arch anteriorly. Patients with an acute or chronic infection or inflammation in the area intended for implant placement. Patient unable to commit to 15 year follow-up. Patients participating in other investigations if the present protocol cannot be properly adhered to. Patients referred only for implant placement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant mobility assessed manually with the removed prosthesis and/or any infection dictating implant removal. Assessments will be done at 1, 3, 5, 7, 10, 15 years of loading. Implants, if not rotating, will be considered as successful.Timepoint: Assessments will be done at 1,3,5,7,10 years of loading | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Marginal bone levels on intra-oral radiographs. 2. Oral Health Impact Profile OHIP-14 (quality of life) 3. Patientsâ?? number of days with total or partial impaired activity assessed at delivery of the provisional prosthesis. 4.Time to function 5.Number of sessions with the dentistTimepoint: 1, 3, 5, 7, 10 and 15 years after loading. | — |
Countries
Belgium, China, Germany, India, Italy, Spain, Switzerland, United Kingdom
Contacts
Public ContactDr Gunaseelan Rajan
Chennai Dental Research Foundation
Outcome results
None listed