Schnederian Membrane Elevation and Augmentation With Deproteinized Bovine Bone [Tutu-gen Bone] Versus Graft Less Tenting Technique With Simultaneous Implant Placement

Study Overview
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Brief Summary
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30 recruited patients indicated for sinus membrane elevation with simultaneous implant placement. patients are divided into 2 groups each group contain 15 patients, one group assigned for placement of bovine bone graft after membrane elevation and insertion of the implants while the other group assigned for graft-less tenting technique after membrane elevation and insertion of the implant.

Detailed Description
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On the 2 groups a mucoperiosteal flap is elvated then a lateral wondow is created then sinus membrane is elevated then the implants are placed, in the control group deproteinized bovine bone graft substitute is placed in the sinus for augmentation while in the study group no bone graft is added inside the sinus( graftless tenting technique)

Official Title
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Schnederian Membrane Elevation and Augmentation With Deproteinized Bovine Bone [Tutu-gen Bone] Versus Graft Less Tenting Technique With Simultaneous Implant Placement: Randomized Clinical Trial

Conditions
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Maxillary Sinus Floor Elevation

Intervention / Treatment
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* Procedure: sinus lift,implant placement,tenting
* Procedure: sinus lift,implant placement,bovine bone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with atrophic maxilla and pneumatization of the maxillary sinus with residual bone height at least 5mm as per MISCH criteria. both sexes. Exclusion Criteria: sinus pathology heavy smokers(more than 20 cigarettes per day. patients with systemic disease that may affect normal healing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sinus lift,implant placement,tenting<br>elevation of the sinus membrane with simultaneous implant placement without the use of any bone graft material(tenting technique) | Procedure: sinus lift,implant placement,tenting<br>* elevation of the sinus membrane then insertion of the implants without any bone graft material( graft-less) for augmentation<br>|
| Active Comparator: sinus lift,implant placement,bovine bone<br>elevation of the sinus membrane with simultaneous implant placement together with deproteinized bovine bone graft substitute for augmentation | Procedure: sinus lift,implant placement,bovine bone<br>* sinus membrane elevation then placement of the implants together with deproteinized bovine bone substitute as a graft material for augmentation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction | evaluation of post operative complications in terms of pain and edema using patient pain chart | 7 days post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant stability | measurement of the implant stability using the osstell device | will be measured intraoperatively immediately after insertion of the implants and will be measure one more time 6 months after the 1st operation at the time of exposure of the implants | 
| height of bone gained or lost around the implants | two cone beam computed tomography(CBCT) will be taken for the patient, one immediate postoperative and the other 6 months after the operation then the height of bone gained or lost around the implants will be assessed by superimposing the same section in the two CBCTS. | 6 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tenting, grafting, implant placement