An interventional study of Appliance. Orthodontic appliance to carry out dentoalveolar movement in Cleft Lip and Cleft Palate, sponsored by Universidad Complutense de Madrid. Not yet recruiting. Open to participants aged 7 Days to 1 Month. Per ClinicalTrials.gov, last updated 2025-04-25.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
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.
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 planned as soon as possible after the patient's birth, once the patient has been diagnosed with CLP and once the caregivers have been duly informed about the clinical trial, as well as its advantages and disadvantages.
The main objective (MO) of this study is to analyze the changes that occur in the dental arches of a newborn patient, diagnosed with CLP, with PSIO performed with transparent aligners, a technique that is very different from that performed in this type of surgery in patients to date.
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 116 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →Universidad Complutense de Madrid is the lead sponsor of 206 studies on the registry; 64 are open to participants now.
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.
Patients selected for the clinical trial must meet these criteria after randomization:
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.
Patients treated with clear aligners to bring cleft segments closer previous to primary lip surgery. An average of 15 aligners will be needed although it depends on the cleft.
Device: Appliance. Orthodontic appliance to carry out dentoalveolar movement
The reference therapeutic action (no pre-surgical orthopedic intervention previous to primary lip surgery)
A 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.
Also known as: Clear Aligners
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)
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)
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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