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

Cairo University8 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cleft of Alveolar Ridge

Interventions

Osmed self inflating tissue expandersDEVICE

Osmed self inflating tissue expanders will be placed 21 days before bone grafting the cleft to gain soft tissue coverage

Iliac bone graftOTHER

Bone grafting the cleft without the use of osmed self inflating tissue expander

Eligibility

Sex: ALLMin age: 7 YearsMax age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cairo university

Giza, Egypt

Outcomes

Primary Outcomes

Primary Outcome : Absence of nasal regurgitation. Binary (Yes/No)

Time frame: 21 days

Secondary Outcomes

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

Time frame: 6 months

Data from ClinicalTrials.gov

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