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Status unknownNCT03732885Updated Nov 7, 2018

Maxillary Sinus Floor Elevation Using DENSAH Burs Versus Summers Osteotomes

An interventional study of densah burs osseo densification drills and Summer's Osteotomes in Implant Tissue Failure, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-07.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
25 Years to 55 Years
Sex
All
01

Study summary

To investigate the efficacy of osseodensification drills (Densah bure) as a new closed sinus lift tool and to compare the effect of it in bone gaine versus traditional osteotomes.

02

Conditions studied

  • Implant Tissue Failure

Keywords

  • Sinus
  • Stability
  • Bone gain
  • Osseodensification
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients with partially edentulous in the posterior area of the maxilla, with a residual ridge that allowed insertion of ≤8 mm length implants.
  • both sexes.
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement.

Exclusion criteria

Exclusion Criteria:

  • Sinus pathology.
  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems.
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    densah burs drilling group

    maxillary sinus floor elevation during implant placement using Densah burs

    Device: densah burs osseo densification drills

  • Experimental
    Summers osteotomes

    maxillary sinus floor elevation during implant placement using Summer's Osteotomes

    Device: Summer's Osteotomes

Interventions

  • Devicedensah burs osseo densification drills

    maxillary sinus floor elevation during implant placement using Densah burs

  • DeviceSummer's Osteotomes

    maxillary sinus floor elevation during implant placement using Summer's Osteotomes

06

What researchers measure

Primary outcomes

  1. implant stability

    measurement of implant stability using the Ostell

    Time frame: 6 months after surgery

Secondary outcomes

  1. bone gain

    measurement of bone gain around implant using cone-beam computed tomography CBCT

    Time frame: 6 months after surgery

07

Study locations

1 site
  • Sohaib M Elsheikh
    Cairo, 11311, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03732885
Lead sponsor
Cairo University
Responsible party
Sohaib Mohamed Alzamzamy Mohamed Elsheikh (principal investigator, Cairo University) — Principal investigator
First posted
Nov 7, 2018
Start date
Nov 1, 2018 (estimated)
Primary completion
Apr 15, 2019 (estimated)
Completion
Jul 15, 2019 (estimated)
Last update
Nov 7, 2018

Study contacts

Sohaib M Elsheikh, masters
Contact
alzamzamy44@hotmail.com
00201222500517 ext. 0

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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