Effects of AlignBabyCleft (ABaCleft)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-1
SponsorUniversidad Complutense de Madrid
About this trial
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 displaced alveolar segments and restoring the position of the lateral cartilage, thus improving the results of primary surgery. Currently, the most used technique in the different protocols is the nasoalveolar molding (NAM) described by Grayson, from which variants and modifications have emerged in order to improve its results and provide greater comfort for both the patient and their caregivers.
However, the main drawback of traditional acrylic NAM is the need for sequential addition of acrylic to reduce the size of the indentation. These weekly adjustments consume time and resources for the caregiver and the orthodontist. Likewise, it has been observed that acrylic resin can cause inflammation, irritation and gingival ulceration due to excessive pressure.
PSIO treatment in newborns is a complex procedure that could benefit from simplification through digitization, providing accuracy and precision, avoiding risks such as respiratory obstruction and cyanosis that can be produced by taking impressions with alginates or silicones, most of them needing to be performed under general anesthesia.
Until now, infant care has been left out of such digitization, despite the fact that the majority of babies who need early orthodontic treatment often suffer from craniofacial disorders. However, in recent years numerous advances have been made in this type of treatment, both in taking records, and in the application of more physiological, lighter and constant forces, providing greater comfort, better acceptance and less pain for the patient . These changes represent a great advance applicable to patients with CLP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Appliance. Orthodontic appliance to carry out dentoalveolar movement
DeviceA digital 3D model obtained with a 3D scanner: (T1,baseline), (T2, aprox 8 weeks), and at the end of othopedic treatment previous to primary lip surgery (T3, aprox 16 weeks). Once a week, clinical check.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Gold StandardNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Inter arch dimensions
For the analysis of inter-arch dimensions and their clinical significance, 15 arch analysis variables will be studied. An intraoral scan of the patient will be performed to obtain the digitized models in different phases of the treatment. Before the start of treatment with PSIO (0 months), before lip closure (3 months), before palate closure surgery (6 months). The following variables will be recorded anonymously for each patient: * Measurements of arch width: Transverse dimension ( measured in millimeters). * Measurementes of arch depth: Sagital dimension ( mesaured in millimeters). * Alveolar arch length (measured in millimeters). * Arch circumference ( measured in millimeters). * Measurements of alignment of the segments ( measured in millimeters).
Time frame
1 year ( Primary completion)Secondary outcomes
1
Positive aspects for caregivers
Surveys of caregivers reflecting, for later analysis, certain aspects considered positive, provided by the treatment and which will be evaluated as variables in the study. For the answers, a scale with 4 points will be used: 1. Very satisfactory, very happy, more than adequate. 2. Satisfactory, happy, adequate. 3. Unsatisfactory, unhappy, inadequate. 4. Very unsatisfactory, very unhappy, very inadequate.
Time frame
1 year ( primary completion)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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