Cleft Lip and PalateNCT05009472
Rapid Maxillary Expansion and Protraction by Expander Differential Opening EDO in Cleft Lip and Palate Patients
A study testing expander with deferential opening and petit face mask in people with Cleft Lip and Palate, run by Faculty of Dental Medicine for Girls at 2 sites in Egypt.
Trial summary
maxillary expansion in cleft palate patient with expander and using face mask. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- expander with deferential opening 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
- 2 sitesEgypt
- Study dates
- 26 Jun 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
- No healthy volunteers
- Child
Who may be able to join
- ● Patients of both sexes.
- Cleft lip and palate patients.
- All patient age range 8-12 years.
- All the case showed maxillary arch constriction and deficiency.
- All patients had maxillary permanent first molars.
- Primary lip adhesion and palatal closure.
Who cannot join
- • Absent maxillary permanent first molars.
- Patients had received any surgical assisted rapid maxillary expansion, maxillary protraction or fixed orthodontics before.
- Less than two dental unit beside maxillary first molar.
- Uncooperative patients/parents.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of Dental Medicine for Girls Al-Azhar University
Cairo, Nasr City, 0000
taghreed alazzawi, master, 00201001581382, taghreedalazzawi.p5821@azhar.edu.eg
amira eldawr, master, 00201112788674, amiraeldawy.p5821@azhar.edu.eg
- Recruiting
Taghreddd
Cairo
taghreed alazzawi, master, 00201001581382, TaghreedAlazzawi.p5821@azhar.edu.eg
amira eldawy, master, 00201112788674, amiraeldawy.p5821@azhar.edu.eg
About this study
Official title: Evaluation of the Treatment Outcome of Cleft Palate Patients Treated With Differential Opening Expander With Rapid Protocol and Face Mask Using CBCT
maxillary expansion in cleft palate patient with expander and using face mask.
Read the detailed description
patient with cleft palate and maxillary constriction, deficiency will be treat using expander with differential opening which has two screws on anteriorly and another posteriorly positional in midline palate anteriorly as much as possible.
rapid maxillary expansion will be using one turns in day(two turns in the morning and two turns in the evening).
with petit face mask for maxillary protraction and superimposition CBCT will be taken between before and after treatment .
- Conditions
- Cleft Lip and Palate
- Being tested
- expander with deferential opening and petit face mask
- Keywords
- cleft palate patient, Rapid maxillary expansion RME, cone beam computed tomography CBCT, expansion, face mask
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
expander with deferential opening and petit face maskDevice
bonded expander with two screws and vertical hooks for attachment face mask. adjustment face mask with forehead and chin anchorage
| Study group | Role | What they receive |
|---|---|---|
| Cleft Lip and Palate Patient | Experimental | Cleft patient with transverse maxillary constriction and anteroposterior deficiency Receives: Device: expander with deferential opening and 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 posted17 Aug 2021
- Study start26 Jun 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.
- 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, Taghreed riyadh saleh alazzawi, Faculty of Dental Medicine for Girls
- Investigators
- dr. mohsena ahmad, phd, Study director, Lecturer of orthodontics department Faculty of Dental Medicine for Girls Alazhar univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009472
- Sponsor's protocol ID
- ORTHO-109-2-E
- Status last verified
- Aug 2021
- First submitted
- 29 Jul 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: treatment cleft lip and palate patient with EDO with rapid protocol and face mask
Study at a glance
From the registry record, last updated by the sponsor on 17 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 Rapid Protocol and Face Mask Using CBCT
- ClinicalTrials.gov ID
- NCT05009472
- Acronym / sponsor ID
- ORTHO-109-2-E
- Conditions
- Cleft Lip and Palate
- Keywords
- cleft palate patient, Rapid maxillary expansion RME, cone beam computed tomography CBCT, expansion, face mask
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 26 Jun 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 17 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.
maxillary expansion in cleft palate patient with expander and using face mask.
Detailed description
patient with cleft palate and maxillary constriction, deficiency will be treat using expander with differential opening which has two screws on anteriorly and another posteriorly positional in midline palate anteriorly as much as possible.
rapid maxillary expansion will be using one turns in day(two turns in the morning and two turns in the evening).
with petit face mask for maxillary protraction and superimposition CBCT will be taken between before and after treatment .
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 Patient | Experimental | Device: expander with deferential opening and petit face maskCleft patient with transverse maxillary constriction and anteroposterior deficiency |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- ● Patients of both sexes.
Key exclusion criteria (4 listed)
- • Absent maxillary permanent first molars.
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 |
|---|---|---|
| expander with deferential opening and petit face maskbonded expander with two screws and vertical hooks for attachment face mask. adjustment face mask with forehead and chin anchorage | Device | Cleft Lip and Palate Patient |
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 17 Aug 2021.
- Rapid maxillary expansion and face mask with class III malocclusionLink provided by the sponsor.
- Individual participant dataSharing planned: No. treatment cleft lip and palate patient with EDO with rapid protocol and face mask
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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.
dr. mohsena ahmad, phd study director
Lecturer of orthodontics department Faculty of Dental Medicine for Girls Alazhar univercity
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing expander with deferential opening and petit face mask in people with Cleft Lip and Palate, run by Faculty of Dental Medicine for Girls at 2 sites 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 17 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 2 sites 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 taghreed alazzawi, master (00201001581382, TaghreedAlazzawi.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?
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 17 Aug 2021.