Cleft of Alveolar Ridge
Conditions
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.
Interventions
DEVICEOsmed self inflating tissue expanders
Osmed self inflating tissue expanders will be placed 21 days before bone grafting the cleft to gain soft tissue coverage
OTHERIliac bone graft
Bone grafting the cleft without the use of osmed self inflating tissue expander
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 13 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome : Absence of nasal regurgitation. Binary (Yes/No) | 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome : absence of soft tissue Dehiscence and preservation of bone graft volume , volume per cubic meter(Measured by cbct) | 6 months |
Countries
Egypt
Outcome results
None listed