Dental Prosthesis Clinical Trial
Official title:
Titanium Versus Soft Metal CAD/CAM Frameworks for All-on-4 Implant Supported Prosthesis. A Study of Peri-implant Changes and Framework Adaptation
This study is aimed to compare between titanium framework and soft metal framework used for mandibular All-on-4 implant supported prosthesis. The evaluation will be for: - Peri-implant soft tissue health including; Plaque index, Probing depth and bleeding index. - Bone level changes around implant using periapical x-ray after 6 months and 12 months and 18 months from insertion of fixed prosthesis. - Framework adaptation of titanium framework and soft metal framework using surface matching software. Patient grouping: • 20 Patients will be classified into 2 equal groups, first group will receive 4 implants placed according to All on 4 concept supporting screw retained prosthesis with titanium framework manufactured by dry milling technique, second group will receive 4 implants placed according to All on 4 concept supporting screw retained prosthesis with metal framework manufactured by dry milling/post sintering of Co-Cr soft metal blocks. The evaluation will be for: • Bone level changes around implant using periapical x-ray after 6 months and 12 months and 18 months from insertion of fixed prosthesis.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | May 20, 2025 |
Est. primary completion date | April 20, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 40 Years to 60 Years |
Eligibility | Inclusion Criteria: - Completely edentulous maxillary and mandibular ridges with sufficient mandibular bone height in the inter-foraminal area confirmed with panoramic x-rays. - All selected patients will be with sufficient inter-arch space and restorative space. - All selected patients will have apparently healthy ridge covered by compressible oral mucosa and free from any ridge flabbiness. Exclusion Criteria: - Patients with systemic diseases that contraindicate implant placement such as hematologic diseases, serious problems of coagulation and diseases of the immune system. Also, metabolic diseases related to bone resorption such as uncontrolled diabetics or osteoporosis will be also excluded - History of para-functional habits (Bruxism, clenching), smoking and alcoholism. - History of radiation therapy in the head and neck region. |
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura University, Faculty of dentistry | Mansoura |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peri-implant crestal bone resorption | Crestal bone level will be evaluated by Periapical x-ray | at time of insertion of prosthesis procedure T(0), 6 months after insertion T(6), 12 months after insertion T(12), 18 months after insertion (T18) |
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