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出境医 / 临床实验 / Three Dimensional Changes on Nasal Septum and Alveolar Cleft After Maxillary Expansion

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

Study Description
Brief 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.

Condition or disease Intervention/treatment
Nasal Septum; Deviation, Congenital Cleft Lip and Palate Maxillary Hypoplasia Procedure: Maxillary Expansion

Detailed 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.

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Three Dimensional Changes on Nasal Septum and Alveolar Cleft After Maxillary Expansion: A Case Series
Actual Study Start Date : February 2009
Actual Primary Completion Date : March 2019
Actual Study Completion Date : May 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date June 4, 2019
First Posted Date June 6, 2019
Last Update Posted Date June 7, 2019
Actual Study Start Date February 2009
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 4, 2019) 		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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Three Dimensional Changes on Nasal Septum and Alveolar Cleft After Maxillary Expansion
Official Title Three Dimensional Changes on Nasal Septum and Alveolar Cleft After Maxillary Expansion: A Case Series
Brief 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.
Detailed 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 40 unilateral cleft lip and palate patients (UCLP) (23 male and 17 female), aging from 8 to 14 years old (mean age of 11.1 years ± 2.2). All subjects were in prepubertal or pubertal stage of maturation based on the cervical vertebrae maturation19 assessed on reconstructed lateral cephalograms generated from CBCT.
Condition
  • Nasal Septum; Deviation, Congenital
  • Cleft Lip and Palate
  • Maxillary Hypoplasia
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.
Other Name: Palatal expansion technique
Study Groups/Cohorts Not Provided
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 4, 2019) 		40
Original Actual Enrollment Same as current
Actual Study Completion Date May 2019
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 14 Years   (Child)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03976609
Other Study ID Numbers Maxillary Expansion Cleft Pts
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Patient's individual data might be available upon a reasonable request
Responsible Party Ildeu Andrade Jr., Pontifícia Universidade Católica de Minas Gerais
Study Sponsor Pontifícia Universidade Católica de Minas Gerais
Collaborators Not Provided
Investigators
Principal Investigator: Ildeu Andrade Jr., DDS, MS, PhD Pontifícia Universidade Católica de Minas Gerais
PRS Account Pontifícia Universidade Católica de Minas Gerais
Verification Date June 2019

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