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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03175458
Enrollment
30
Registered
2017-06-05
Start date
2016-07-31
Completion date
2017-07-31
Last updated
2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Sinus Floor Elevation

Keywords

tenting, grafting, implant placement

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)

Interventions

PROCEDUREsinus lift,implant placement,tenting

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

PROCEDUREsinus 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
patient satisfaction7 days post operativeevaluation of post operative complications in terms of pain and edema using patient pain chart

Secondary

MeasureTime frameDescription
implant stabilitywill 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 implantsmeasurement of the implant stability using the osstell device
height of bone gained or lost around the implants6 months postoperativetwo 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026