Rapid Maxillary Expansion and Protraction by Expander Differential Opening EDO in Cleft Lip and Palate Patients

Not Applicable

• Conditions: Cleft Lip and Palate
• Interventions: Device: expander with deferential opening and petit face mask

• Registration Number: NCT05009472
• Lead Sponsor: Faculty of Dental Medicine for Girls

Brief Summary

maxillary expansion in cleft palate patient with expander and using face mask.

Detailed Description

patient with cleft palate and maxillary constriction, deficiency will be treat using expander with differential opening which has two screws on anteriorly and another posteriorly positional in midline palate anteriorly as much as possible.

rapid maxillary expansion will be using one turns in day(two turns in the morning and two turns in the evening).

with petit face mask for maxillary protraction and superimposition CBCT will be taken between before and after treatment .

Study Timeline

• Study Start: 2021-06-26
• Study First Submitted: 2021-07-29
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-11
• Last Update Submitted: 2021-08-11
• Study First Posted: 2021-08-17
• Last Update Posted: 2021-08-17
• Primary Completion: 2022-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• ● Patients of both sexes.

  • Cleft lip and palate patients.
  • All patient age range 8-12 years.
  • All the case showed maxillary arch constriction and deficiency.
  • All patients had maxillary permanent first molars.
  • Primary lip adhesion and palatal closure.

Exclusion Criteria

• • Absent maxillary permanent first molars.

  • Patients had received any surgical assisted rapid maxillary expansion, maxillary protraction or fixed orthodontics before.
  • Less than two dental unit beside maxillary first molar.
  • Uncooperative patients/parents.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cleft Lip and Palate Patient	expander with deferential opening and petit face mask	Cleft patient with transverse maxillary constriction and anteroposterior deficiency

Primary Outcome Measures

Name	Time	Method
Changes in 3 dimensions of skull before and after expansion	Six months	Full skull Cone Beam Computerized Tomography

Trial Locations

Locations (2)

Faculty of Dental Medicine for Girls Al-Azhar University; 🇪🇬 Cairo, Nasr City, Egypt

Taghreddd; 🇪🇬 Cairo, Egypt