The Use of Self Inflating Tissue Expanders In The Treatment Of Alveolar Cleft

January 4, 2017 updated by: Sherif Hany shams, Cairo University
patient receiving treatment using the osmed expander will have enough soft tissue coverage securing the bone graft which will be placed in a later stage to close the alveolar cleft.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

to prove that the group treated with osmed expanders will suffer no soft tissue dehiscence and will have a higher volume of soft tissue at the stage of bone grafting.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

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
      • Giza, Egypt
        • 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

7 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medically free patients.
  • Patients suffering from alveolar cleft with anterior fistulas.
  • Age Between 7 and 13 Years
  • Both sexes.
  • Patients physically able to tolerate surgical and restorative procedures. Good oral hygiene.
  • Highly motivated patients.

Exclusion Criteria:

  • non motivated patients

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: Osmed self inflating tissue expanders
All patients will undergo a two-stage procedure ,second stage under General endotracheal anesthesia. The first stage will be placement of the expanders. The second stage will be 21 days later, with removal of the expanders, palatal revision, and closure of the oronasal fistula
Device: Osmed self inflating tissue expanders
Osmed self inflating tissue expanders will be placed 21 days before bone grafting the cleft to gain soft tissue coverage
Experimental: Iliac bone graft
Placement of bone graft without the use of self inflating expanders
Other: Iliac bone graft
Bone grafting the cleft without the use of osmed self inflating tissue expander

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary Outcome : Absence of nasal regurgitation. Binary (Yes/No)
Time Frame: 21 days
21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary Outcome : absence of soft tissue Dehiscence and preservation of bone graft volume , volume per cubic meter(Measured by cbct)
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Galal El Behiry, Phd, 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

December 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 27, 2016

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 5, 2017

Study Record Updates

Last Update Posted (Estimate)

January 5, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Cairo university kasr el ainy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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