Non-grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Using Different Implant Lengths

November 3, 2018 updated by: Ahmed Abdulnasser, Cairo University

twenty recruited patients indicated for sinus augmentation and simultaneous implant placement will be divided into two groups (10 in each of the groups).to evaluate & compare bone formation & implant stability after shneiderian membrane elevation and augmentation with graft less tenting technique with different implant lengths.

group one will receive 8mm implant lenght while group two will receive 10mm implants.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

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.

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient with atrophic maxilla & pneumatized maxillary sinus with residual bone height at least 4mm of residual ridge
  • both sexes

Exclusion Criteria:

  • patients with systematic diseases that may affect normal healing
  • sinus pathology
  • heavy smokers more than 20 cigarettes per day

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: placebo
Procedure: maxillary sinus lift
non grafted maxillary sinus floor augmentation with simultaneous implant placement
Experimental: active comparator
Procedure: maxillary sinus lift
non grafted maxillary sinus floor augmentation with simultaneous implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
height of gained bone
Time Frame: 6 months post operative
two cone beam CT will be done for the patients, one immediate post operative & the other 6 months post operative then the amount of gained bone will be assessed by superimposing the same section in the two cone beam CT.
6 months post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implant stability
Time Frame: will be measured intra operative after implant insertion and will be measured once more 6 months post operative after the first operation at the time of implant exposure
measurement of the implant stability using OSSTELL device.
will be measured intra operative after implant insertion and will be measured once more 6 months post operative after the first operation at the time of implant exposure

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)

January 1, 2019

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 15, 2019

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

November 3, 2018

First Posted (Actual)

November 6, 2018

Study Record Updates

Last Update Posted (Actual)

November 6, 2018

Last Update Submitted That Met QC Criteria

November 3, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • aaali.cairo university

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.

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