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OpenTrials
Completed

NCT Number: NCT04331977

Effectiveness of Two Maxillary Expanders in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate

This randomized controlled trial is designed to compare between quadlelix appliance vs hyrax expander regrading the their effectiveness in maxillary expansion in patients with cleft.

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Key information

Conditions

Cleft Lip and Palate Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lip Diseases Maxillary Expansion Mouth Abnormalities Mouth Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Cairo, Giza Governorate, 00202, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mixed dentition stage;
  • Both males and females;
  • Lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age;
  • Presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft;
  • Permanent first maxillary molars present;
  • Good periodontal health;
  • No previous orthodontic treatment; and

Exclusion criteria

  • Presence of a syndrome in companion with the present cleft defect.
  • Previous secondary alveolar bone grafting.
  • Taking medications affecting growth.

Treatment and study plan

Maxillary Expansion

Device

2 appliances to expand the maxillary arch

Primary outcomes

  1. Maxillary Expansion

    Time frame: 6 months

    Amount of Maxillary Expansion to be measured as distances (mm) on CBCTs and dental models.

  2. Maxillary Expansion

    Time frame: 6 months

    mount of Maxillary Expansion to be measured as angles (degrees) on CBCTs and dental models.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effectiveness of Two Rapid Maxillary Expanders (Quadhelix vs Hyrax) in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate: A Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 2, 2020
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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