Atrophied Posterior Maxilla
Conditions
Keywords
Implant, Bone ring, Sinus lift.
Brief summary
Two groups of patients with atrophy in posterior maxilla indicated for sinus lift. First group will be subjected to open sinus lift with chin bone graft. Second group will be subjected to sinus floor elevation using a bone ring.
Detailed description
Two groups of patients with atrophy in posterior maxilla indicated for sinus lift. (A) First group will be subjected to open sinus lift with chin bone graft. * All cases will undergo surgery under general anesthesia for sinus lift and other surgery under local anesthesia for implant placement . * Exposure of the anterior wall of maxilla according to standardized surgical approach. * Open sinus lift and bone graft. * After 6 months, implant will be drilled and inserted in the recipient site according to standard protocol. * Loading on implant after 5-6 months. (B)Second group will be subjected to sinus floor elevation using a bone ring. * All cases will undergo surgery under local anesthesia for implant placement in the mandibular chin and other surgery under general anesthesia for sinus lift using bone ring with the implant. * Exposure of the mandibular chin will be done under local anesthesia using a standardized surgical approach. * Implant will be drilled and inserted in the chin according to standard protocol. * After 3 months, second surgery under general anesthesia to place the implant and surrounding ring in the atrophied posterior maxilla. * The bone ring containing the implant allowed to heal for 5-6 months. Follow up: * Clinical evaluation will be performed at the first week post-operative. * Three months post-operative second surgery to put the implant with surrounding ring in atrophied posterior maxilla. * Five months post-operative to the second surgery, implant will be loaded with the final restoration.
Interventions
PROCEDUREOpen sinus lift using chin bone graft
Patients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach.
PROCEDURESinus lift using bone ring containing the implant.
Patients with atrophied posterior maxilla will undergo sinus lift with chin bone ring containing the implant.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Because the two interventions used in this trial are clearly different and easily recognized by the participants and investigators, neither the investigators nor participants can be blinded.
Intervention model description
* A Randomized controlled trial. * Parallel group study. * A trial will be carried out in hospital of Oral and Maxillofacial surgery department- Faculty of Oral and Dental Medicine Cairo University * Equal randomization: participants with equal probabilities for intervention. * Positive controlled: Both groups receiving treatment.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients with at least a unilateral atrophied posterior maxilla indicated for open sinus lift and graft. 2. All ages and both sexes were included in this study. 3. Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome. 4. Patients with good general condition allowing surgical procedure under general anesthesia. 5. Patients with physical and psychological tolerance.
Exclusion criteria
1. Patients with high risk systemic diseases like uncontrolled diabetes. As uncontrolled diabetes has a negative impact on normal bone healing. 2. Patients with chronic sinusitis, maxillary sinus tumor or cyst. As they will affect accuracy of the procedure. 3. Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. \]
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate of implant | One year post-operative. | The estimated annual failure rate will be assessed via clinical assessment, measuring unit (Binary yes\\ no) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marginal bone loss around implant | one year post operative | Bone loss around implant will be assessed using Cone Beam Computed Tomography, measuring unit (millimeter). |
| Pain intensity | One month post-operative. | Intensity of pain will be assessed using Visual analog scale (0 -10), 0 indicate no pain,10 indicate unbearable pain. |
| Sinus membrane perforation | During operation | Perforation of sinus lining will be assessed clinically, (Binary yes\\no). |
| Established bone integration | Six months post operative. | Structural and functional integration of bone around implant will be assessed using a device with measuring unit scale of 1-100. |
Countries
Egypt
Contacts
Primary ContactMohamed K Hassan, MSc.
Outcome results
None listed