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

Cleft Lip and Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03976609
• Other study ID #: Maxillary Expansion Cleft Pts
• Status: Completed
• Start date: February 2009
• Est. completion date: May 2019

Study information

• Verified date: June 2019
• Source: Pontifícia Universidade Católica de Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2019
• Est. primary completion date: March 2019
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate
• Maxillary Hypoplasia
• Nasal Septum; Deviation, Congenital

Intervention

Procedure:
• Maxillary Expansion
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pontifícia Universidade Católica de Minas Gerais

References & Publications (5)

Aziz T, Wheatley FC, Ansari K, Lagravere M, Major M, Flores-Mir C. Nasal septum changes in adolescent patients treated with rapid maxillary expansion. Dental Press J Orthod. 2016 Jan-Feb;21(1):47-53. doi: 10.1590/2177-6709.21.1.047-053.oar. — View Citation

Jiang M, You M, Wang S, Wang K, Feng B, Wang H. Analysis of Nasal Septal Deviation in Cleft Palate and/or Alveolus Patients Using Cone-Beam Computed Tomography. Otolaryngol Head Neck Surg. 2014 Aug;151(2):226-31. doi: 10.1177/0194599814531022. Epub 2014 Apr 16. — View Citation

Long RE Jr, Spangler BE, Yow M. Cleft width and secondary alveolar bone graft success. Cleft Palate Craniofac J. 1995 Sep;32(5):420-7. — View Citation

Mordente CM, Palomo JM, Horta MC, Souki BQ, Oliveira DD, Andrade I Jr. Upper airway assessment using four different maxillary expanders in cleft patients: A cone-beam computed tomography study. Angle Orthod. 2016 Jul;86(4):617-24. doi: 10.2319/032015-174.1. Epub 2015 Nov 23. — View Citation

Quereshy FA, Barnum G, Demko C, Horan M, Palomo JM, Baur DA, Jannuzzi J. Use of cone beam computed tomography to volumetrically assess alveolar cleft defects--preliminary results. J Oral Maxillofac Surg. 2012 Jan;70(1):188-91. doi: 10.1016/j.joms.2011.01.027. Epub 2011 May 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alterations on Nasal septum	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.	1 - 2 months
Primary	Changes in the alveolar cleft dimensions	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.	1 - 2 months
Secondary	Anterior and posterior maxillary basal width changes	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.	1 - 2 months