One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis

Study Overview
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Brief Summary
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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
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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.

Official Title
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One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis: (A Randomized Controlled Trial)

Conditions
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Atrophied Posterior Maxilla

Intervention / Treatment
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* Procedure: Open sinus lift using chin bone graft
* Procedure: Sinus lift using bone ring containing the implant.


Participation Criteria
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Eligibility Criteria
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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. ]
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open sinus lift using chin bone graft<br>Patients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach. | Procedure: Open sinus lift using chin bone graft<br>* Patients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach.<br>* Other names: Lateral sinus approach with chin graft;|
| Experimental: Sinus lift using bone ring containing the implant<br>Patients with atrophied posterior maxilla will undergo sinus lift using bone ring containing the implant. | Procedure: Sinus lift using bone ring containing the implant.<br>* Patients with atrophied posterior maxilla will undergo sinus lift with chin bone ring containing the implant.<br>* Other names: One stage sinus lift using bone ring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate of implant | The estimated annual failure rate will be assessed via clinical assessment, measuring unit (Binary yes\ no) | One year post-operative. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal bone loss around implant | Bone loss around implant will be assessed using Cone Beam Computed Tomography, measuring unit (millimeter). | one year post operative | 
| Pain intensity | Intensity of pain will be assessed using Visual analog scale (0 -10), 0 indicate no pain,10 indicate unbearable pain. | One month post-operative. | 
| Sinus membrane perforation | Perforation of sinus lining will be assessed clinically, (Binary yes\no). | During operation | 
| Established bone integration | Structural and functional integration of bone around implant will be assessed using a device with measuring unit scale of 1-100. | Six months post operative. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implant, Bone ring, Sinus lift.