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

Phase 1

• Conditions: Cleft of Alveolar Ridge
• Interventions: Device: Osmed self inflating tissue expanders; Other: Iliac bone graft

• 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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.

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Exclusion Criteria

• non motivated patients

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osmed self inflating tissue expanders	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
Iliac bone graft	Iliac bone graft	Placement of bone graft without the use of self inflating expanders

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