Status:
NOT_YET_RECRUITING
Effects of AlignBabyCleft (ABaCleft)
Lead Sponsor:
Universidad Complutense de Madrid
Conditions:
Cleft Lip
Cleft Palate
Eligibility:
All Genders
7-1 years
Phase:
NA
Brief Summary
Since the appearance of presurgical infant orthopedic (PSIO) as a treatment for patients with cleft lip and palate ( CLP) , numerous techniques have been described with the aim of aligning the displac...
Detailed Description
The AlingBabyCleft (AbaCleft) trial will be designed as a randomized controlled clinical trial, with an investigator blinded, superiority trial with two parallel arms. Active treatment will be planne...
Eligibility Criteria
Inclusion
- Patients selected for the clinical trial must meet these criteria after randomization:
- All patients born at term, without any syndrome associated with CLP, aged between 7 days and one month of life, referred from the different hospitals of the Spanish Health System, will be included in the study.
- No distinction will be made on the basis of race or ethnic group to which the participants belong.
- Any patient will be discriminated due to distance from their place of residence.
- Participants must agree to attend regular check-ups.
- All patients who agree to be part of the experimental study must previously sign the specific informed consent designed for this purpose.
Exclusion
- Caregivers who are not fluent in the Spanish language will be excluded in order to understand and assimilate all the instructions provided for treatment compliance.
- Patients who do not comply with the regimen of visits to the orthodontic department, and for whom a correct control of the evolution of the treatment cannot be guaranteed, will be excluded from the study.
- Lack of collaboration or non-compliance with the use of the clear aligners will also be considered grounds for exclusion.
- Patients with soft tissue bands should also be excluded from our study.
Key Trial Info
Start Date :
November 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05357092
Start Date
November 21 2025
End Date
November 1 2028
Last Update
April 25 2025
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