Cleft Lip and PalateNCT04997083
Slow Expansion and Protraction in Cleft Lip and Palate Patients
A study testing Maxillary Expander with Differential Opening (EDO) and Petit face mask in people with Cleft Lip and Palate, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
Evaluate the treatment outcome of slow maxillary expansion protocol on patients with cleft lip and palate, using a differential opening expander and face mask which will be measured and recorded by cone beam computed tomography (CBCT). Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Maxillary Expander with Differential Opening (EDO) and Petit face mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2021to Jul 2023
- Phase
- Interventional
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All patient age ranges from 8 to 12 years.
- Patients of both sexes.
- Cleft lip and palate patients.
- All the cases showed maxillary arch constriction and deficiency.
- All patients had maxillary permanent first molars.
- Primary lip adhesion and palatal closure.
Who cannot join
- Patients had received any surgical assisted rapid maxillary expansion or maxillary protraction of fixed orthodontics before.
- Maxillary dentition unsuitable to bond the expander (less than two dental units beside permanent first molar).
- Absent maxillary permanent first molars.
- Uncooperative patients/parents.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dental medicine for girls, Al-Azhar University
Cairo, Nasr City, 0000
Mohsena A. Abdelrazq, PhD, +201005839539, MohsenaAhmad.el.8.383@azhar.edu.eg
About this study
Official title: Evaluation of the Treatment Outcome of Cleft Palate Patients Treated With Differential Opening Expander With Slow Protocol and Face Mask
Evaluate the treatment outcome of slow maxillary expansion protocol on patients with cleft lip and palate, using a differential opening expander and face mask which will be measured and recorded by cone beam computed tomography (CBCT).
Read the detailed description
Cleft lip and palate are among the most common deformities in children. Cleft patients are usually having orofacial problems as missing or unerupted permanent teeth, alveolar bone defect, speech difficulty. Patients with cleft lip and palate (CLP) commonly have maxillary arch constriction (maxillary hypoplasia) and Class III malocclusions due to deficient of maxillary growth. The upper jaw of patients with cleft palate will be expanded using maxillary Expander with Differential Opening (EDO) which has two screws; one anterior and one posterior. This will be done with slow expansion protocol, which is one 1/4 turn three times weekly. Petit facemask will be used to protract the retracted maxilla. The differences in measurements between before and after treatment will be assessed by cone beam computed tomography (CBCT).
- Conditions
- Cleft Lip and Palate
- Being tested
- Maxillary Expander with Differential Opening (EDO), Petit face mask
- Keywords
- Cleft lip and palate, Expansion, Slow expansion, Maxillary expander with differential opening (EDO), Protraction, Face mask, Cone beam computed tomography (CBCT)
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary Expander with Differential Opening (EDO)Device
The EDO is designed with two expansion screws positioned transversely. When more expansion is required between the canines, the anterior screw can be further activated. Both expansion screws can be activated to open in a parallel configuration. Pivoting corner screws allow for different amounts of expansion without significant risk of binding during activation.
Petit face maskDevice
The face mask is anatomical, multi-adjustable, lightweight and an ideal therapeutic alternative for the correction of Class III malocclusion. It consists of forehead cap, chin cap, and cross bar.
| Study group | Role | What they receive |
|---|---|---|
| cleft lip and palate patients | Experimental | Cleft patients with transverse maxillary constriction and anteroposterior deficiency Receives: Device: Maxillary Expander with Differential Opening (EDO); Device: Petit face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 3 dimensions of skull before and after expansion
Full skull Cone Beam Computerized Tomography
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start15 Jul 2021
- Primary completionJul 2022 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cleft Lip and PalateStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amira Helmy Abdulsattar Eldawy, Faculty of Dental Medicine for Girls
- Investigators
- Amany M. Diab, PhD, Study director, Lecturer of Orthodontics Department, Faculty of Dental Medicine for Girls, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997083
- Sponsor's protocol ID
- ORTHO-109-2-D
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Evaluation of EDO, Slow maxillary expansion and facemask in patients with cleft lip and palate (CLP) using Cone Beam Computed Tomography (CBCT)
Publications
Alves ACM, Janson G, Mcnamara JA Jr, Lauris JRP, Garib DG. Maxillary expander with differential opening vs Hyrax expander: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 Jan;157(1):7-18. doi: 10.1016/j.ajodo.2019.07.010.
PubMed 31901284Massaro C, Garib D, Cevidanes L, Janson G, Yatabe M, Lauris JRP, Ruellas AC. Maxillary dentoskeletal outcomes of the expander with differential opening and the fan-type expander: a randomized controlled trial. Clin Oral Investig. 2021 Sep;25(9):5247-5256. doi: 10.1007/s00784-021-03832-9. Epub 2021 Feb 12.
PubMed 33580351
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Treatment Outcome of Cleft Palate Patients Treated With Differential Opening Expander With Slow Protocol and Face Mask
- ClinicalTrials.gov ID
- NCT04997083
- Acronym / sponsor ID
- ORTHO-109-2-D
- Conditions
- Cleft Lip and Palate
- Keywords
- Cleft lip and palate, Expansion, Slow expansion, Maxillary expander with differential opening (EDO), Protraction, Face mask, Cone beam computed tomography (CBCT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 9 Aug 2021 (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.
Evaluate the treatment outcome of slow maxillary expansion protocol on patients with cleft lip and palate, using a differential opening expander and face mask which will be measured and recorded by cone beam computed tomography (CBCT).
Detailed description
Cleft lip and palate are among the most common deformities in children. Cleft patients are usually having orofacial problems as missing or unerupted permanent teeth, alveolar bone defect, speech difficulty. Patients with cleft lip and palate (CLP) commonly have maxillary arch constriction (maxillary hypoplasia) and Class III malocclusions due to deficient of maxillary growth. The upper jaw of patients with cleft palate will be expanded using maxillary Expander with Differential Opening (EDO) which has two screws; one anterior and one posterior. This will be done with slow expansion protocol, which is one 1/4 turn three times weekly. Petit facemask will be used to protract the retracted maxilla. The differences in measurements between before and after treatment will be assessed by cone beam computed tomography (CBCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cleft lip and palate patients | Experimental | Device: Maxillary Expander with Differential Opening (EDO), Device: Petit face maskCleft patients with transverse maxillary constriction and anteroposterior deficiency |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- All patient age ranges from 8 to 12 years.
- Patients of both sexes.
- Cleft lip and palate patients.
- All the cases showed maxillary arch constriction and deficiency.
- All patients had maxillary permanent first molars.
Key exclusion criteria (4 listed)
- Patients had received any surgical assisted rapid maxillary expansion or maxillary protraction of fixed orthodontics before.
- Maxillary dentition unsuitable to bond the expander (less than two dental units beside permanent first molar).
- Absent maxillary permanent first molars.
- Uncooperative patients/parents.
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 Expander with Differential Opening (EDO)The EDO is designed with two expansion screws positioned transversely. When more expansion is required between the canines, the anterior screw can be further activated. Both expansion screws can be activated to open in a parallel configuration. Pivoting corner screws allow for different amounts of expansion without significant risk of binding during activation. | Device | cleft lip and palate patients |
| Petit face maskThe face mask is anatomical, multi-adjustable, lightweight and an ideal therapeutic alternative for the correction of Class III malocclusion. It consists of forehead cap, chin cap, and cross bar. | Device | cleft lip and palate patients |
Primary outcome
Changes in 3 dimensions of skull before and after expansion
Time frame: Six months
Full skull Cone Beam Computerized Tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Background: PubMed 31901284Alves ACM, Janson G, Mcnamara JA Jr, Lauris JRP, Garib DG. Maxillary expander with differential opening vs Hyrax expander: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 Jan;157(1):7-18. doi: 10.1016/j.ajodo.2019.07.010.
- Background: PubMed 33580351Massaro C, Garib D, Cevidanes L, Janson G, Yatabe M, Lauris JRP, Ruellas AC. Maxillary dentoskeletal outcomes of the expander with differential opening and the fan-type expander: a randomized controlled trial. Clin Oral Investig. 2021 Sep;25(9):5247-5256. doi: 10.1007/s00784-021-03832-9. Epub 2021 Feb 12.
- Maxillary dentoskeletal outcomes of the expander with differential opening and the fan-type expander: a randomized controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: No. Evaluation of EDO, Slow maxillary expansion and facemask in patients with cleft lip and palate (CLP) using Cone Beam Computed Tomography (CBCT)
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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.
Amany M. Diab, PhD study director
Lecturer of Orthodontics Department, Faculty of Dental Medicine for Girls, Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary Expander with Differential Opening (EDO) and Petit face mask in people with Cleft Lip and Palate, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira H. Eldawy, Master (+201112788674, amiraeldawy.p5821@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 3 dimensions of skull before and after expansion (time frame: Six months). 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 NCT04997083, which also lists 2 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 9 Aug 2021.