A Comparative Study to Evaluate Bone Height Gain Following Transcrestal Sinus Floor Elevation Using Specially Designed Drills Versus the Conventional Osteotome Technique.

Not Applicable

• Conditions: Compromised Vertical Bone Height in the Maxillary Posterior Region
• Interventions: Device: Dask Advanced Sinus kit

• Registration Number: NCT02926781
• Lead Sponsor: Cairo University

Brief Summary

Radiographic evaluation of the amount of bone height gain and clinical evaluation of the possibility of developing complications after transcrestal sinus floor elevation using drills and the conventional osteotome technique.

Detailed Description

Short implants (\< 10 mm) are one of the options used to overcome low vertical bone height in the maxilla. However, short implants have faced many challenges as smaller implant surface; therefore less bone-to-implant contact after osseointegration with force distribution on a reduced surface after loading. This leads to more crestal bone resorption with more threads exposure decreasing the long term implant success Another treatment option is placing implants in specific anatomical areas, such as the pterygoid region or the zygoma .Many complications are reported as postoperative sinusitis, temporary paresthesia, epistaxis, facial, periorbital hematoma, orbital penetration and prosthetic difficulties due to the implants palatal emergence.

Vertical augmentation with bone grafts is another treatment option. However, it has many drawbacks as the unpredictable graft resorption, low bone to implant contact, higher possibility of wound dehiscence, as well as compromised implant position leading to undesirable prosthetic restorations.

To overcome the problems of the previously mentioned procedures, elevation of the sinus membrane techniques were proposed, it can be performed either through a lateral window , or via a crestal access depending on the remaining bone height (RBH). If the RBH is around 6-9 mm, the crestal approach is indicated. If the RBH is less than 5 mm, a lateral approach should be performed.

For the crestal approach, it could be performed by the conventional osteotome technique. However, it is a visually restrictive technique which may lead to sinus perforation as well as it can cause some complications as headache and paroxysmal positional vertigo (Saker e Ogle, 2005; Peñarrocha-Diago et al., 2008).

To overcome the disadvantages of the conventional osteotome technique, various kits have been developed for transcrestal sinus floor elevations using specially designed drills.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-05
• Last Update Submitted: 2016-10-05
• Study First Posted: 2016-10-06
• Last Update Posted: 2016-10-06
• Study Start: 2016-11
• Primary Completion: 2017-01
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drills	Dask Advanced Sinus kit	transcrestal sinus floor elevation using drills
osteotome technique	Dask Advanced Sinus kit	transcrestal sinus floor elevation using osteotomes

Primary Outcome Measures

Name	Time	Method
bone height gain	6 months