Unilateral Cleft Lip and PalateNCT05837780
Effect of Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients
A study testing Nasoalveolar molding device in people with Unilateral Cleft Lip and Palate, run by Minia University at 1 site in Egypt.
Trial summary
This study includes Three Dimensional Evaluation of Maxillary Arch Changes After Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients (Randomized Controlled Trial) Null hypothesis: there is no difference between using conventionally constructed… Read more about this study
- Who is it for?
- Ages 7 days to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Unilateral Cleft Lip and Palate
- What is being tested?
- Nasoalveolar molding device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2023to Oct 2025
- 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 7 days to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Good general health without any systematic disease, disability or other syndromes Non syndromatic unilateral cleft lip and palate Both genders Age less than one month Parents willing to participate in the study and sign informed consent
Who cannot join
- Patients exhibiting systemic disease, disability or other syndrome, parents denying participating in the study or not given their informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three Dimensional Evaluation of Maxillary Arch Changes After Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients (Randomized Controlled Trial)
This study includes Three Dimensional Evaluation of Maxillary Arch Changes After Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients (Randomized Controlled Trial) Null hypothesis: there is no difference between using conventionally constructed nasoalveolar molding device and using digitally constructed nasoalveolar molding device
- Conditions
- Unilateral Cleft Lip and Palate
- Being tested
- Nasoalveolar molding device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasoalveolar molding deviceOther
comparison between using conventionally and digitally constructed nasoalveolar molding devices
| Study group | Role | What they receive |
|---|---|---|
| conventionally constructed nasoalveolar molding devices (control group) | Experimental | control group: patients receiving conventionally constructed nasoalveolar molding devices Receives: Other: Nasoalveolar molding device |
| Digitally constructed nasoalveolar molding devices (test group) | Experimental | test group: patients receiving digitally constructed nasoalveolar molding devices Receives: Other: Nasoalveolar molding device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar cleft width
measurement of width between two alveolar segments
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start3 Jan 2023
- Primary completionJan 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by Minia 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Alaa Abd el Aziz, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837780
- Sponsor's protocol ID
- Clp04042024
- Status last verified
- Jul 2024
- First submitted
- 20 Apr 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Evaluation of Maxillary Arch Changes After Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients (Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT05837780
- Acronym / sponsor ID
- Clp04042024
- Conditions
- Unilateral Cleft Lip and Palate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 1 May 2023 (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 includes Three Dimensional Evaluation of Maxillary Arch Changes After Using Two Different Construction Techniques of Nasoalveolar Molding Devices in Unilateral Cleft Lip and Palate Patients (Randomized Controlled Trial) Null hypothesis: there is no difference between using conventionally constructed nasoalveolar molding device and using digitally constructed nasoalveolar molding device
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventionally constructed nasoalveolar molding devices (control group) | Experimental | Other: Nasoalveolar molding devicecontrol group: patients receiving conventionally constructed nasoalveolar molding devices |
| Digitally constructed nasoalveolar molding devices (test group) | Experimental | Other: Nasoalveolar molding devicetest group: patients receiving digitally constructed nasoalveolar molding devices |
Who may qualify
- Ages
- 7 days to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Good general health without any systematic disease, disability or other syndromes Non syndromatic unilateral cleft lip and palate Both genders Age less than one month Parents willing to participate in the study and sign informed consent
Key exclusion criteria (1 listed)
- Patients exhibiting systemic disease, disability or other syndrome, parents denying participating in the study or not given their informed consent
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 |
|---|---|---|
| Nasoalveolar molding devicecomparison between using conventionally and digitally constructed nasoalveolar molding devices | Other | Digitally constructed nasoalveolar molding devices (test group), conventionally constructed nasoalveolar molding devices (control group) |
Primary outcome
Alveolar cleft width
Time frame: 3 months
measurement of width between two alveolar segments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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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 Nasoalveolar molding device in people with Unilateral Cleft Lip and Palate, run by Minia 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 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: status not confirmed, as of the sponsor's last update on 23 Jul 2024. 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?
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?
Alveolar cleft width (time frame: 3 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 23 Jul 2024.