An interventional study of Nasoalveolar molding device in Unilateral Cleft Lip and Palate, sponsored by Minia University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 7 Days to 1 Month, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Minia University · Not applicable, Interventional, and Treatment
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
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 36 is above the median of 30 across 116 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
control group: patients receiving conventionally constructed nasoalveolar molding devices
Other: Nasoalveolar molding device
test group: patients receiving digitally constructed nasoalveolar molding devices
Other: Nasoalveolar molding device
comparison between using conventionally and digitally constructed nasoalveolar molding devices
Alveolar cleft width
measurement of width between two alveolar segments
Time frame: 3 months
Started Jan 2023 (actual). Primary completion is estimated for Jan 2025, 24 months after the start.
Of 64 non-industry interventional studies with no phase under Cleft Lip, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 33. This study's planned 24 months is close to that.
Counting every sponsor, half of 65 studies reached it within 22 months; a quarter within 15 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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