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

NCT ID: NCT04236466

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2021-03-31

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 .

Conditions

Cleft Lip and Palate

Study Design

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

Study Groups

hyrax group

cleft lip and palate patients with hyrax appliance

Group Type: EXPERIMENTAL

hyrax appliance

Intervention Type: DEVICE

Hyrax will be constructed with bands on maxillary first molars and wire extending on palatal surfaces of teeth till the upper canines.

haas group

cleft lip and palate patients with haas appliance

Group Type: EXPERIMENTAL

haas appliance

Intervention Type: DEVICE

Haas will be constructed with bands on maxillary first molars and wire extending on palatal surfaces of teeth till the upper canines. Acrylic part will be added on palate

Interventions

hyrax appliance

Hyrax will be constructed with bands on maxillary first molars and wire extending on palatal surfaces of teeth till the upper canines.

Intervention Type: DEVICE

haas appliance

Haas will be constructed with bands on maxillary first molars and wire extending on palatal surfaces of teeth till the upper canines. Acrylic part will be added on palate

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yomna Elfiky

teaching assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yomna ElFiky

Role: CONTACT

princessyomna7@outlook.com

01001987078 ext. 01001987078

Other Identifiers

3-3-4

Identifier Type: -

Identifier Source: org_study_id