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NCT Number: NCT05357092

Effects of AlignBabyCleft (ABaCleft)

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.

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Key information

Conditions

Cleft Lip Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Lip Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

7 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Appliance. Orthodontic appliance to carry out dentoalveolar movement

Device

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.

Other names: Clear Aligners

Primary outcomes

Inter arch dimensions

Time frame: 1 year ( Primary completion)
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).

Secondary outcomes

Positive aspects for caregivers

Time frame: 1 year ( primary completion)
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.

Study contacts

Contact information is provided by the study sponsor or research team.

ANA RABAL SOLANS

CONTACT

[email protected]

915756135 ext. 915756135

ROSA YAÑEZ VICO

CONTACT

[email protected]

913941982 ext. 913941982

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Acronym: (ABaCleft)

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: May 2, 2022
Registry last updated: Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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