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

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Unknown
Phase 1

Conditions

Cleft of Alveolar Ridge

Treatments

Device: Osmed self inflating tissue expanders
Other: Iliac bone graft

Study type

Interventional

Funder types

Other

Identifiers

NCT03010345
Cairo university kasr el ainy

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

7 to 13 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

8 participants in 2 patient groups

Osmed self inflating tissue expanders
Experimental group
Description:
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
Treatment:
Device: Osmed self inflating tissue expanders
Iliac bone graft
Experimental group
Description:
Placement of bone graft without the use of self inflating expanders
Treatment:
Other: Iliac bone graft

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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