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

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.

Study Overview

• Status: Unknown
• Conditions: Cleft Lip and Palate
• Intervention / Treatment: Device: hyrax appliance; Device: haas appliance

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: hyrax group; cleft lip and palate patients with hyrax appliance	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.
EXPERIMENTAL: haas group; cleft lip and palate patients with haas appliance	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maxillary and mandibular anteroposterior measurements	They will be measured on digital casts by linear measurements(mm)	3 months
Maxillary and mandibular anteroposterior measurements	They will be measured on digital casts by linear measurements(mm)	6 months
Maxillary and mandibular anteroposterior measurements	They will be measured on CBCT by linear and angular measurements(mm and angles)	6 months
Vertical skeletal measurents	They will be measured on CBCT by linear and angular measurements(mm and angles)	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2020
• Primary Completion (ANTICIPATED): March 1, 2021
• Study Completion (ANTICIPATED): March 1, 2021

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (ACTUAL): January 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: maxillary expansion
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: 3-3-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No