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NCT Number: NCT03976609

Three Dimensional Changes on Nasal Septum and Alveolar Cleft After Maxillary Expansion

This study evaluates, by means of cone beam computed tomography (CBCT), the alterations in the nasal septum and alveolar cleft volume that occur in cleft lip and palate (CLP) patients after rapid maxillary expansion(RME). 40 unilateral CLP patients (mean age, 11.1 ± 2.2 years) with transverse maxillary deficiency that underwent to RME will be evaluated in this investigation. CBCT images were taken prior to RME (T0) and after the removal of the expander (T1), for adequate secondary bone graft surgical planning. The scans will be used to analyze the effects on the nasal septum, anterior and posterior maxillary basal width (MBW) and alveolar cleft volume.

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Key information

About this study

Rapid maxillary expansion (RME) is performed to correct crossbite in CLP patients as part of the orthodontic treatment, being able to improve the maxillary transverse dimension, that is an essential condition for alveolar bone grafting. The primary aim of the secondary graft surgery is to restore the function and structure of the maxillary arch at the cleft side, providing support to arch width, minimizing its transverse collapse. However, since RME exert heavy forces to separate the two maxillary helves, it may significantly widen the alveolar cleft defect, possibly compromising bone graft success.

Moreover, RME has an important impact on the geometry and function of the nasal cavity, providing a lateral displacement of the walls and facilitating the airflow through the upper airways. These effects are very important to CLP patients, since they usually present reduced upper airway dimensions, adenoid hypertrophy, sleep disorders, oral breathing, and a marked nasal septal deviation. The nasal septal deviation is one of the major causes of nasal obstruction in non-cleft patients, and often results in blocking of the nasolacrimal ducts, sinusitis, ear infections and mouth breathing. However, nasal septum deviation in CLP patients commonly persists even after surgical repair of the cleft, leading to a chronic obstruction of the air passage, until the septorhinoplasty, at the age of 14-18 years.

Each expander was cemented with a fluoride releasing cement, and the activation regimen was established at 2 turns/day until the tip of the lingual cusps of the maxillary teeth touched the tips of the buccal cusps of the mandibular teeth. After the 3-month retention period, the expander was removed, and a post-expansion CBCT scanning (T1) was acquired for adequate secondary bone graft surgical planning.

Who can participate

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

Inclusion criteria

  • The inclusion criteria comprehended the presence of unilateral cleft lip and palate, rapid maxillary expansion as an initial part of the orthodontic treatment, and absence of previous orthodontic treatment.

Exclusion criteria

  • The exclusion criteria were absent maxillary permanent first molars, signs of active periodontal disease, and presence of any additional craniofacial syndrome.

Treatment and study plan

Maxillary expansion

Procedure

The patients with maxillary transverse deficiency were treated with Haas expander is a tooth and tissue-borne appliance with a jackscrew located at the anterior region of the arch with its arms bent posteriorly and soldered to the first permanent molar bands. Once activated, the appliances opens the palatal suture and increase the transverse dimension of the maxilla.

Other names: Palatal expansion technique

Primary outcomes

  1. Alterations on Nasal septum

    Time frame: 1 - 2 months

    Maxillary expansion performed with 2 activations per day until the tip of the lingual cusps of the maxillary teeth touched the tips of the buccal cusps of the mandibular teeth.

  2. Changes in the alveolar cleft dimensions

    Time frame: 1 - 2 months

    Maxillary expansion performed with 2 activations per day until the tip of the lingual cusps of the maxillary teeth touched the tips of the buccal cusps of the mandibular teeth.

Secondary outcomes

  1. Anterior and posterior maxillary basal width changes

    Time frame: 1 - 2 months

    Maxillary expansion performed with 2 activations per day until the tip of the lingual cusps of the maxillary teeth touched the tips of the buccal cusps of the mandibular teeth.

Sponsors and collaborators

Lead sponsor

Pontifícia Universidade Católica de Minas Gerais

Other

Registry information

Official study title

Three Dimensional Changes on Nasal Septum and Alveolar Cleft After Maxillary Expansion: A Case Series

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Jun 6, 2019
Registry last updated
Jun 7, 2019

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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