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

NCT03010345 | Unknown Phase 1

• 1 other identifier: Cairo university kasr el ainy
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft of Alveolar Ridge

Outcome Measures

Primary Outcomes (1)

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

  21 days

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

Osmed self inflating tissue expanders

EXPERIMENTAL

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

Device: Osmed self inflating tissue expanders

Iliac bone graft

EXPERIMENTAL

Placement of bone graft without the use of self inflating expanders

Other: Iliac bone graft

Interventions

Osmed self inflating tissue expanders DEVICE

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

Osmed self inflating tissue expanders

Iliac bone graft OTHER

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

Iliac bone graft

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• non motivated patients

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Giza, Egypt

Location

Study Officials

• Galal El Behiry, Phd

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: January 5, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 5, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)