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

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

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.

Study Overview

• Status: Unknown
• Conditions: Maxillary Sinus Floor Elevation
• Intervention / Treatment: Procedure: sinus lift,implant placement,tenting; Procedure: sinus lift,implant placement,bovine bone

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)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2017
• Last Update Submitted That Met QC Criteria: June 1, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: grafting; tenting; implant placement
• Other Study ID Numbers: cebc.cu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No