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

Cleft Lip and Palate Clinical Trial

Official title:

Transverse Dento-skeletal Effects of Two Rapid Palatal Expansion Appliances in Cleft Lip and Palate Patients : A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04236466
• Other study ID #: 3-3-4
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: March 2021

Study information

• Verified date: January 2020
• Source: Cairo University
• Contact: Yomna ElFiky
• Phone: 01001987078
• Email: princessyomna7[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tranverse dental changes	assessed on digital models by linear measurements (mm)	3 months
Primary	Tranverse dental changes	assessed on digital models by linear measurements(mm)	6 months
Primary	Tranverse skeletal changes	assessed on CBCT by linear and angular measurements(mm and angles)	6 months
Secondary	Maxillary and mandibular anteroposterior measurements	They will be measured on digital casts by linear measurements(mm)	3 months
Secondary	Maxillary and mandibular anteroposterior measurements	They will be measured on digital casts by linear measurements(mm)	6 months
Secondary	Maxillary and mandibular anteroposterior measurements	They will be measured on CBCT by linear and angular measurements(mm and angles)	6 months
Secondary	Vertical skeletal measurents	They will be measured on CBCT by linear and angular measurements(mm and angles)	6 months