Nasal Septum; Deviation, CongenitalNCT03976609
Three Dimensional Changes on Nasal Septum and Alveolar Cleft After Maxillary Expansion
An observational study of Nasal Septum; Deviation, Congenital and Cleft Lip and Palate, run by Pontifícia Universidade Católica de Minas Gerais.
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). Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Nasal Septum; Deviation, Congenital, Cleft Lip and Palate, Maxillary Hypoplasia
- What is being tested?
- Maxillary Expansion
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- Child
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.
Who may be able to join
- 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.
Who cannot join
- The exclusion criteria were absent maxillary permanent first molars, signs of active periodontal disease, and presence of any additional craniofacial syndrome.
About this study
Official title: Three Dimensional Changes on Nasal Septum and Alveolar Cleft After Maxillary Expansion: A Case Series
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.
Read the 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.
- Being tested
- Maxillary Expansion
- Keywords
- Nasak Septum, Cleft Lip, Cleft palate, Palatal expansion technique
- Medical subject headings
- Cleft Lip, Retrognathia, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary ExpansionProcedure or surgery
Also called Palatal expansion technique
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 - 2 months
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.
Measured: 1 - 2 months
Secondary outcomes (1)
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.
Measured: 1 - 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study startFeb 2009
- Primary completionMar 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nasal Septum; Deviation, CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontifícia Universidade Católica de Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ildeu Andrade Jr., Pontifícia Universidade Católica de Minas Gerais
- Investigators
- Ildeu Andrade Jr., DDS, MS, PhD, Principal investigator, Pontifícia Universidade Católica de Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976609
- Sponsor's protocol ID
- Maxillary Expansion Cleft Pts
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2019
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient's individual data might be available upon a reasonable request
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.
PubMed 24740983Aziz 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.
PubMed 27007761Mordente 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.
PubMed 26595658Quereshy 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.
PubMed 21549490Long RE Jr, Spangler BE, Yow M. Cleft width and secondary alveolar bone graft success. Cleft Palate Craniofac J. 1995 Sep;32(5):420-7. doi: 10.1597/1545-1569_1995_032_0420_cwasab_2.3.co_2.
PubMed 7578207
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Changes on Nasal Septum and Alveolar Cleft After Maxillary Expansion: A Case Series
- ClinicalTrials.gov ID
- NCT03976609
- Acronym / sponsor ID
- Maxillary Expansion Cleft Pts
- Keywords
- Nasak Septum, Cleft Lip, Cleft palate, Palatal expansion technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pontifícia Universidade Católica de Minas GeraisUniversity, hospital or other
- Study start
- Feb 2009 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- The exclusion criteria were absent maxillary permanent first molars, signs of active periodontal disease, and presence of any additional craniofacial syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maxillary ExpansionAlso: Palatal expansion techniqueThe 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. | Procedure or surgery | – |
Primary outcome
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.
1 secondary outcome
Anterior and posterior maxillary basal width changes
Time frame: 1 - 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Background: PubMed 24740983Jiang 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.
- Background: PubMed 27007761Aziz 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.
- Background: PubMed 26595658Mordente 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.
- Background: PubMed 21549490Quereshy 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.
- Background: PubMed 7578207Long RE Jr, Spangler BE, Yow M. Cleft width and secondary alveolar bone graft success. Cleft Palate Craniofac J. 1995 Sep;32(5):420-7. doi: 10.1597/1545-1569_1995_032_0420_cwasab_2.3.co_2.
- Individual participant dataSharing planned: No. Patient's individual data might be available upon a reasonable request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ildeu Andrade Jr., DDS, MS, PhD principal investigator
Pontifícia Universidade Católica de Minas Gerais
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Septum; Deviation, Congenital and Cleft Lip and Palate, run by Pontifícia Universidade Católica de Minas Gerais.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alterations on Nasal septum (time frame: 1 - 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03976609, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.