One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis: (A Randomized Controlled Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrophied Posterior Maxilla
- Sponsor
- Cairo University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Survival rate of implant
- Last Updated
- 7 years ago
Overview
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.
Investigators
Mohamed kamel hassan
Assistant lecturer
Cairo University
Eligibility Criteria
Inclusion Criteria
- •Patients with at least a unilateral atrophied posterior maxilla indicated for open sinus lift and graft.
- •All ages and both sexes were included in this study.
- •Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- •Patients with good general condition allowing surgical procedure under general anesthesia.
- •Patients with physical and psychological tolerance.
Exclusion Criteria
- •Patients with high risk systemic diseases like uncontrolled diabetes. As uncontrolled diabetes has a negative impact on normal bone healing.
- •Patients with chronic sinusitis, maxillary sinus tumor or cyst. As they will affect accuracy of the procedure.
- •Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. \]
Outcomes
Primary Outcomes
Survival rate of implant
Time Frame: One year post-operative.
The estimated annual failure rate will be assessed via clinical assessment, measuring unit (Binary yes\\ no)
Secondary Outcomes
- Pain intensity(One month post-operative.)
- Established bone integration(Six months post operative.)
- Marginal bone loss around implant(one year post operative)
- Sinus membrane perforation(During operation)