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

Phase 1

• Conditions: Cleft of Alveolar Ridge

• Registration Number: NCT03010345
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-27
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-04
• Last Update Submitted: 2017-01-04
• Study First Posted: 2017-01-05
• Last Update Posted: 2017-01-05
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Giza, Egypt