Marginal Bone Loss, One-piece Implants Versus Two-piece Implants During the Osseointegration Phase
Conditions
Keywords
one-piece implants , All-On-Four, Marginal bone loss
Brief summary
Evaluating the bone changing after receiving one-piece implants supported full arch prosthesis compared to the conventional two-piece implants.
Detailed description
Studying the difference between one-piece and two-piece implants and their effect on bone loss. This will help in simplifying the surgical procedure for full arch implant-supported prosthesis rehabilitation using one-piece implants, eliminating the disturbance of the gum tissue around the implants, potentially reducing the risk of bacterial colonization and inflammation.
Interventions
DEVICEOne-piece dental implants with MUA
one-piece dental implants with multi-units abutment mounted on the implants as a single piece provided with different abutment angulation utilizing these implants for All-On-Four prothesis
DEVICETwo-piece dental implants
Surgical and immediate loading procedures: On the day of implant placement, patients will receive two-piece implant. After crestal incision and full-thickness flap elevation, the implant sites will be prepared aided by a surgical template. 4 implants will be placed, two aligned in an axial orientation and two will be distally aligned (17 degrees). The standard placement procedure as recommended by the manufacturer will be used. The surgical drills with increasing diameters will be used to prepare the implant sites. Implants will be ideally placed at bone level (or 1 mm deeper depending on the soft tissue thickness). After 3 months as a healing phase, a definitive prosthesis will be fabricated using the same abutments, and the marginal bone loss after the osseointegration phase will be assessed.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Completely edentulous patients, who can sign an informed consent will be considered eligible for this trial. * Residual bone height should have sufficient volume and quality for implant placement with a minimum of 12-14 mm in height and 6 mm in width. * Patients who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, technical problems concerning denture design and/or occlusion are found, or who are dissatisfied with the retention and stability of their technically satisfactory mandibular dentures.
Exclusion criteria
* \- Patients with conditions that may contraindicate implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino bisphosphonates, patients undergoing radiotherapy to the head and neck region). * Inadequate mouth opening * Heavy smokers, more than 10 cigarettes/day * Patients with poor oral hygiene and motivation. * Pregnancy or nursing. * Drug abusers. * Psychiatric problems or unrealistic expectations. * Patients with infection and or inflammation in the area intended for implant placement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peri-implant marginal bone loss | From implant placement (baseline) and After 3 months (after the osseointegration phase) | Peri-implant marginal bone loss will be assessed utilizing CBCT. The radiographic evaluation will be performed at baseline and at 3 months after functional loading. Using the first thread of the implant as a standard reference point, the circumference of the Crestal bone level around the implant will be measured in all directions (mesial, distal, buccal, and lingual) in width and height. |
Countries
Egypt
Contacts
Primary ContactEsraa kh Mahdy
Outcome results
None listed