Effects of AlignBabyCleft (ABaCleft)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Presurgical Orthopedics in Patients With Cleft Lip and/or Palate, a Randomized Controlled Clinial Trial.

Conditions
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Cleft Lip, Cleft Palate

Intervention / Treatment
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* Device: Appliance. Orthodontic appliance to carry out dentoalveolar movement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 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.<br>* Other names: Clear Aligners;|
| No Intervention: Gold Standard<br>The reference therapeutic action (no pre-surgical orthopedic intervention previous to primary lip surgery) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 year ( Primary completion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: Very satisfactory, very happy, more than adequate. Satisfactory, happy, adequate. Unsatisfactory, unhappy, inadequate. Very unsatisfactory, very unhappy, very inadequate. | 1 year ( primary completion) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cleft lip,  Cleft palate, presurgical orthopedics