Transverse Dento-skeletal Effects of Two Rapid Palatal Expansion Appliances in Cleft Lip and Palate Patients

Not Applicable

• Conditions: Cleft Lip and Palate

• Registration Number: NCT04236466
• Lead Sponsor: Cairo University

Brief Summary

Aim of the study: to compare the effect of Hyrax appliance and the Haas appliance improving the transverse skeletal and dental dimensions in cleft lip and palate patients during mixed dentition.

Detailed Description

•Steps in short Full records pre-treatment. Bands selection for upper first molars then construction of expansion appliances(Haas or Hyrax) . Delivery of appliances and instructions to the patients and their parents about their activation regimen 2 quarter turns in the morning and 2 in the evening.The posterior crossbite will be measured as the distance from the palatal cusp tips of upper first molars to central fossae of lower first molars then the needed time for expansion will be calculated .When the time calculated for correction ends, we will stop activation, we will take impressions for digital models to see if real expansion occurred or not and so testing the efficiency of the two appliances.

Afterthat, if correction was not yet achieved, activation of the appliances will continue till overcorrection at the molar region with the palatal cusp tip of the maxillary posterior teeth contacting the buccal cusp tip of the mandibular posterior teeth. We will then leave the appliance insitu for retention.

After 6 months from the first CBCT we will take a second CBCT to see any bony changes .

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-17
• Last Update Submitted: 2020-01-17
• Study First Posted: 2020-01-22
• Last Update Posted: 2020-01-22
• Study Start: 2020-03
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• (1) Mixed dentition; (2) Both males and females; (3) Lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age; (4) Presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft; (5) Permanent first maxillary molars present; (6) Good periodontal health; (7) No previous orthodontic treatment;

Exclusion Criteria

• (1) Presence of a syndrome in companion with the present cleft defect (2) Previous secondary alveolar bone grafting (3)Taking medications affecting growth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tranverse skeletal changes	6 months	assessed on CBCT by linear and angular measurements(mm and angles)
Tranverse dental changes	6 months	assessed on digital models by linear measurements(mm)

Secondary Outcome Measures

Name	Time	Method
Maxillary and mandibular anteroposterior measurements	6 months	They will be measured on CBCT by linear and angular measurements(mm and angles)
Vertical skeletal measurents	6 months	They will be measured on CBCT by linear and angular measurements(mm and angles)