Effects of AlignBabyCleft (ABaCleft)

Launched by UNIVERSIDAD COMPLUTENSE DE MADRID · Apr 26, 2022

Keywords

ClinConnect Summary

The clinical trial titled "Effects of AlignBabyCleft (ABaCleft)" is exploring a new way to help babies born with cleft lip and cleft palate. The researchers are studying the use of a digital approach to presurgical infant orthopedic treatment, which aims to align the baby's jaw and improve the results of surgery. This study hopes to simplify the current treatment methods, which can be complicated and uncomfortable for both babies and their families. By using digital techniques, the goal is to reduce the need for painful adjustments and make the process safer and more comfortable.

To take part in this trial, babies must be between 7 days and 1 month old and born at full term, with no other syndromes related to cleft lip and palate. Importantly, families must be able to communicate in Spanish and commit to attending regular check-ups to monitor the baby's progress. Participants will receive care that is designed to be more comfortable and effective, helping to improve their overall treatment experience. If you think your baby might be eligible, reach out to your healthcare provider for more information about this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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 Criteria:
• • 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.