Cleft Lip and PalateNCT04331977
Effectiveness of Two Maxillary Expanders in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate
A study testing Maxillary Expansion in people with Cleft Lip and Palate and Maxillary Expansion, run by Cairo University at 1 site in Egypt.
Trial summary
This randomized controlled trial is designed to compare between quadlelix appliance vs hyrax expander regrading the their effectiveness in maxillary expansion in patients with cleft. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate, Maxillary Expansion
- What is being tested?
- Maxillary Expansion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jul 2020to 30 Dec 2022
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mixed dentition stage;
- Both males and females;
- Lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age;
- Presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft;
- Permanent first maxillary molars present;
- Good periodontal health;
- No previous orthodontic treatment; and
Who cannot join
- Presence of a syndrome in companion with the present cleft defect.
- Previous secondary alveolar bone grafting.
- Taking medications affecting growth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Two Rapid Maxillary Expanders (Quadhelix vs Hyrax) in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate: A Randomized Clinical Trial
This randomized controlled trial is designed to compare between quadlelix appliance vs hyrax expander regrading the their effectiveness in maxillary expansion in patients with cleft.
- Conditions
- Cleft Lip and Palate, Maxillary Expansion
- Being tested
- Maxillary Expansion
- 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 ExpansionDevice
2 appliances to expand the maxillary arch
| Study group | Role | What they receive |
|---|---|---|
| Quadhelix Group | Experimental | Not described Receives: Device: Maxillary Expansion |
| Hyrax Group | Active comparator | Not described Receives: Device: Maxillary Expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary Expansion
Amount of Maxillary Expansion to be measured as distances (mm) on CBCTs and dental models.
Measured: 6 months
Maxillary Expansion
mount of Maxillary Expansion to be measured as angles (degrees) on CBCTs and dental models.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start2 Jul 2020
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abd El-Ghafour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331977
- Sponsor's protocol ID
- 121
- Status last verified
- Feb 2023
- First submitted
- 30 Mar 2020
- Last updated
- 14 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Rapid Maxillary Expanders (Quadhelix vs Hyrax) in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04331977
- Acronym / sponsor ID
- 121
- Conditions
- Cleft Lip and Palate, Maxillary Expansion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 2 Apr 2020 (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 randomized controlled trial is designed to compare between quadlelix appliance vs hyrax expander regrading the their effectiveness in maxillary expansion in patients with cleft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadhelix Group | Experimental | Device: Maxillary Expansion |
| Hyrax Group | Active comparator | Device: Maxillary Expansion |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Mixed dentition stage;
- Both males and females;
- Lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age;
- Presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft;
- Permanent first maxillary molars present;
Key exclusion criteria (3 listed)
- Presence of a syndrome in companion with the present cleft defect.
- Previous secondary alveolar bone grafting.
- Taking medications affecting growth.
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 Expansion2 appliances to expand the maxillary arch | Device | Hyrax Group, Quadhelix Group |
Primary outcome
Maxillary Expansion
Time frame: 6 months
Amount of Maxillary Expansion to be measured as distances (mm) on CBCTs and dental models.
Maxillary Expansion
Time frame: 6 months
mount of Maxillary Expansion to be measured as angles (degrees) on CBCTs and dental models.
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 14 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Expansion in people with Cleft Lip and Palate and Maxillary Expansion, run by Cairo University 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 7 inclusion and 3 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 14 Feb 2023. 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?
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?
Maxillary Expansion (time frame: 6 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?
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 14 Feb 2023.