Effects of AlignBabyCleft (ABaCleft) ((ABaCleft))

April 26, 2022 updated by: Universidad Complutense de Madrid

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: ROSA YAÑEZ VICO
  • Phone Number: 913941982 913941982
  • Email: rosayanez@ucm.es

Study Contact Backup

  • Name: ANA RABAL SOLANS
  • Phone Number: 915756135 915756135
  • Email: anarabal@ucm.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 1 month (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group

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

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
NO_INTERVENTION: Gold Standard
The reference therapeutic action (no pre-surgical orthopedic intervention previous to primary lip surgery)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. Very satisfactory, very happy, more than adequate.
  2. Satisfactory, happy, adequate.
  3. Unsatisfactory, unhappy, inadequate.
  4. Very unsatisfactory, very unhappy, very inadequate.
1 year ( primary completion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Investigators

  • Study Director: ROSA YAÑEZ VICO, COMPLUTENSE UNIVERITY OF MADRID

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2022

Primary Completion (ANTICIPATED)

November 1, 2023

Study Completion (ANTICIPATED)

November 1, 2025

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (ACTUAL)

May 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The 360º Cleft Project -ABa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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