Maxillary Sinus Floor Elevation Using DENSAH Burs Versus Summers Osteotomes

November 5, 2018 updated by: Sohaib Mohamed Alzamzamy Mohamed Elsheikh, Cairo University

Crestal Maxillary Sinus Floor Elevation Using Osseodensification Drills (Densah Burs) Versus Summers Osteotomes

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11311
        • Sohaib M Elsheikh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: densah burs drilling group
maxillary sinus floor elevation during implant placement using Densah burs
Device: densah burs osseo densification drills
maxillary sinus floor elevation during implant placement using Densah burs
Experimental: Summers osteotomes
maxillary sinus floor elevation during implant placement using Summer's Osteotomes
Device: Summer's Osteotomes
maxillary sinus floor elevation during implant placement using Summer's Osteotomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implant stability
Time Frame: 6 months after surgery
measurement of implant stability using the Ostell
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone gain
Time Frame: 6 months after surgery
measurement of bone gain around implant using cone-beam computed tomography CBCT
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

April 15, 2019

Study Completion (Anticipated)

July 15, 2019

Study Registration Dates

First Submitted

October 30, 2018

First Submitted That Met QC Criteria

November 5, 2018

First Posted (Actual)

November 7, 2018

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NCT035

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Implant Tissue Failure

Clinical Trials on densah burs osseo densification drills

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe