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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04236466
Enrollment
20
Registered
2020-01-22
Start date
2020-03-31
Completion date
2021-03-31
Last updated
2020-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip and Palate

Keywords

maxillary expansion

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 .

Interventions

DEVICEhyrax appliance

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

DEVICEhaas 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Tranverse dental changes3 monthsassessed on digital models by linear measurements (mm)
Tranverse skeletal changes6 monthsassessed on CBCT by linear and angular measurements(mm and angles)

Secondary

MeasureTime frameDescription
Maxillary and mandibular anteroposterior measurements3 monthsThey will be measured on digital casts by linear measurements(mm)
Vertical skeletal measurents6 monthsThey will be measured on CBCT by linear and angular measurements(mm and angles)

Contacts

Primary ContactYomna ElFiky
princessyomna7@outlook.com01001987078

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026