Titanium Mesh Versus Collagen Membrane for Closure of Window in Maxillary Sinus Elevation With Implant Placement

January 16, 2018 updated by: mostafa mahmoud abd el fattah, Cairo University

Titanium Mesh Versus Collagen Membrane for Closure of Lateral Window Approach in Maxillary Sinus Floor Elevation With Simultaneous Implant Placement. Randomized Controlled Clinical Trial

Evaluation the amount of bone height gained when using titanium mesh in closing the lateral window of the sinus compared to collagen membrane.Evaluation the quality of new bone gained when using of the titanium mesh to close the lateral window of the maxillary sinus as a new option for tenting compared to collagen membrane.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

this study is aimed to review the bone height, quality and closure of lateral osteotomy used for maxillary sinus floor lifting comparing titanium mesh to collagen membrane.

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • Egypt
    • الجيزة
      • Cairo, الجيزة, Egypt
        • Faculty of Dentistry, Cairo University

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • no signs of sinus pathology non or light smokers less than 20 cigarettes per day no systemic disease that may affect normal healing no pscychiatric problems no history of neoplasms or radiation therapy to the head and neck no previous bone augmentation to implant site

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: collagen membrane group
Sinus floor elevation with simultaneous implant placement and closure of the osteotomy with collagen membrane
Procedure: collagen membrane
closing the lateral window for maxillary sinus floor elevaion with collagen membrane
EXPERIMENTAL: titanium mesh group
Sinus floor elevation with simultaneous implant placement and closure of the osteotomy with titanium mesh
Procedure: titanium mesh
closing the lateral window for maxillary sinus floor elevation with titanium mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone height
Time Frame: 6 months
Evaluation the amount of bone height gained when using titanium mesh in closing the lateral window of the sinus compared to collagen membrane .
6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mostafa Mahmoud, Bds, Study Principal Investigator

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 (ACTUAL)

May 13, 2017

Primary Completion (ACTUAL)

November 22, 2017

Study Completion (ACTUAL)

December 17, 2017

Study Registration Dates

First Submitted

January 6, 2018

First Submitted That Met QC Criteria

January 16, 2018

First Posted (ACTUAL)

January 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBC.CU6.1.2018

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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