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

NCT ID: NCT03175458

Last Updated: 2017-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-07-31

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)

Conditions

Maxillary Sinus Floor Elevation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

sinus lift,implant placement,tenting

elevation of the sinus membrane with simultaneous implant placement without the use of any bone graft material(tenting technique)

Group Type: EXPERIMENTAL

sinus lift,implant placement,tenting

Intervention Type: PROCEDURE

elevation of the sinus membrane then insertion of the implants without any bone graft material( graft-less) for augmentation

sinus lift,implant placement,bovine bone

elevation of the sinus membrane with simultaneous implant placement together with deproteinized bovine bone graft substitute for augmentation

Group Type: ACTIVE_COMPARATOR

sinus lift,implant placement,bovine bone

Intervention Type: PROCEDURE

sinus membrane elevation then placement of the implants together with deproteinized bovine bone substitute as a graft material for augmentation

Interventions

sinus lift,implant placement,tenting

elevation of the sinus membrane then insertion of the implants without any bone graft material( graft-less) for augmentation

Intervention Type: PROCEDURE

sinus lift,implant placement,bovine bone

sinus membrane elevation then placement of the implants together with deproteinized bovine bone substitute as a graft material for augmentation

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Waleed Fouad Mahmoud

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

cebc.cu

Identifier Type: -

Identifier Source: org_study_id