Schnederian Membrane Elevation and Augmentation With Deproteinized Bovine Bone [Tutu-gen Bone] Versus Graft Less Tenting Technique With Simultaneous Implant Placement
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 17, 2017
CompletedFirst Posted
Study publicly available on registry
June 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJune 5, 2017
June 1, 2017
1 year
May 17, 2017
June 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
patient satisfaction
evaluation of post operative complications in terms of pain and edema using patient pain chart
7 days post operative
Secondary Outcomes (2)
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
height of bone gained or lost around the implants
6 months postoperative
Study Arms (2)
sinus lift,implant placement,tenting
EXPERIMENTALelevation of the sinus membrane with simultaneous implant placement without the use of any bone graft material(tenting technique)
sinus lift,implant placement,bovine bone
ACTIVE COMPARATORelevation of the sinus membrane with simultaneous implant placement together with deproteinized bovine bone graft substitute for augmentation
Interventions
elevation of the sinus membrane then insertion of the implants without any bone graft material( graft-less) for augmentation
sinus membrane elevation then placement of the implants together with deproteinized bovine bone substitute as a graft material for augmentation
Eligibility Criteria
You may qualify if:
- patients with atrophic maxilla and pneumatization of the maxillary sinus with residual bone height at least 5mm as per MISCH criteria.
- both sexes.
You may not qualify if:
- sinus pathology
- heavy smokers(more than 20 cigarettes per day.
- patients with systemic disease that may affect normal healing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry Cairo University
Cairo, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
May 17, 2017
First Posted
June 5, 2017
Study Start
July 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
June 5, 2017
Record last verified: 2017-06