Transverse Dento-skeletal Effects of Two Rapid Palatal Expansion Appliances in Cleft Lip and Palate Patients
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2020
CompletedFirst Posted
Study publicly available on registry
January 22, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedJanuary 22, 2020
January 1, 2020
1 year
January 15, 2020
January 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Tranverse dental changes
assessed on digital models by linear measurements (mm)
3 months
Tranverse dental changes
assessed on digital models by linear measurements(mm)
6 months
Tranverse skeletal changes
assessed on CBCT by linear and angular measurements(mm and angles)
6 months
Secondary Outcomes (4)
Maxillary and mandibular anteroposterior measurements
3 months
Maxillary and mandibular anteroposterior measurements
6 months
Maxillary and mandibular anteroposterior measurements
6 months
Vertical skeletal measurents
6 months
Study Arms (2)
hyrax group
EXPERIMENTALcleft lip and palate patients with hyrax appliance
haas group
EXPERIMENTALcleft lip and palate patients with haas appliance
Interventions
Hyrax will be constructed with bands on maxillary first molars and wire extending on palatal surfaces of teeth till the upper canines.
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
Eligibility Criteria
You may qualify if:
- (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;
You may not qualify if:
- (1) Presence of a syndrome in companion with the present cleft defect (2) Previous secondary alveolar bone grafting (3)Taking medications affecting growth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- teaching assistant
Study Record Dates
First Submitted
January 15, 2020
First Posted
January 22, 2020
Study Start
March 1, 2020
Primary Completion
March 1, 2021
Study Completion
March 1, 2021
Last Updated
January 22, 2020
Record last verified: 2020-01