Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-25 @ 1:58 PM
Study NCT ID:
NCT05357092
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-25
First Post:
2022-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of AlignBabyCleft (ABaCleft)
Sponsor:
Universidad Complutense de Madrid
Organization:
Study Overview
Official Title:
Evaluation of Presurgical Orthopedics in Patients With Cleft Lip and/or Palate, a Randomized Controlled Clinial Trial.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
(ABaCleft)
Brief Summary:
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.
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:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: