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

NCT ID: NCT03010345

Last Updated: 2017-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-12-31

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.

Conditions

Cleft of Alveolar Ridge

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Osmed self inflating tissue expanders

Intervention Type: DEVICE

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

Iliac bone graft

Placement of bone graft without the use of self inflating expanders

Group Type: EXPERIMENTAL

Iliac bone graft

Intervention Type: OTHER

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

Interventions

Osmed self inflating tissue expanders

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

Intervention Type: DEVICE

Iliac bone graft

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sherif Hany shams

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Galal El Behiry, Phd

Role: STUDY_DIRECTOR

Cairo University

Locations

Cairo university

Giza, , Egypt

Countries

Egypt

Other Identifiers

Cairo university kasr el ainy

Identifier Type: -

Identifier Source: org_study_id