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

Not Applicable

• Conditions: Maxillary Sinus Floor Elevation
• Interventions: Procedure: sinus lift,implant placement,tenting; Procedure: sinus lift,implant placement,bovine bone

• Registration Number: NCT03175458
• Lead Sponsor: Cairo University

Brief Summary

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

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)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2017-05-17
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-01
• Last Update Submitted: 2017-06-01
• Study First Posted: 2017-06-05
• Last Update Posted: 2017-06-05
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

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Exclusion Criteria

• sinus pathology
• heavy smokers(more than 20 cigarettes per day.
• patients with systemic disease that may affect normal healing.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sinus lift,implant placement,tenting	sinus lift,implant placement,tenting	elevation of the sinus membrane with simultaneous implant placement without the use of any bone graft material(tenting technique)
sinus lift,implant placement,bovine bone	sinus lift,implant placement,bovine bone	elevation of the sinus membrane with simultaneous implant placement together with deproteinized bovine bone graft substitute for augmentation

Primary Outcome Measures

Name	Time	Method
patient satisfaction	7 days post operative	evaluation of post operative complications in terms of pain and edema using patient pain chart

Secondary Outcome Measures

Name	Time	Method
implant stability	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	measurement of the implant stability using the osstell device
height of bone gained or lost around the implants	6 months postoperative	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.

Trial Locations

Locations (1)

Faculty of Dentistry Cairo University; 🇪🇬 Cairo, Egypt