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Effects of AlignBabyCleft (ABaCleft) ((ABaCleft))

Primary Purpose

Cleft Lip, Cleft Palate

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Appliance. Orthodontic appliance to carry out dentoalveolar movement
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Lip focused on measuring "cleft lip", " Cleft palate", "presurgical orthopedics"

Eligibility Criteria

7 Days - 1 Month (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Gold Standard

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    March 22, 2022
    Last Updated
    April 26, 2022
    Sponsor
    Universidad Complutense de Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05357092
    Brief Title
    Effects of AlignBabyCleft (ABaCleft)
    Acronym
    (ABaCleft)
    Official Title
    Evaluation of Presurgical Orthopedics in Patients With Cleft Lip and/or Palate, a Randomized Controlled Clinial Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2022 (Anticipated)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    November 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universidad Complutense de Madrid

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cleft Lip, Cleft Palate
    Keywords
    "cleft lip", " Cleft palate", "presurgical orthopedics"

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Gold Standard
    Arm Type
    No Intervention
    Arm Description
    The reference therapeutic action (no pre-surgical orthopedic intervention previous to primary lip surgery)
    Intervention Type
    Device
    Intervention Name(s)
    Appliance. Orthodontic appliance to carry out dentoalveolar movement
    Other Intervention Name(s)
    Clear Aligners
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Inter arch dimensions
    Description
    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)
    Secondary Outcome Measure Information:
    Title
    Positive aspects for caregivers
    Description
    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.
    Time Frame
    1 year ( primary completion)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Days
    Maximum Age & Unit of Time
    1 Month
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ROSA YAÑEZ VICO
    Phone
    913941982
    Ext
    913941982
    Email
    rosayanez@ucm.es
    First Name & Middle Initial & Last Name or Official Title & Degree
    ANA RABAL SOLANS
    Phone
    915756135
    Ext
    915756135
    Email
    anarabal@ucm.es
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ROSA YAÑEZ VICO
    Organizational Affiliation
    COMPLUTENSE UNIVERITY OF MADRID
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32081579
    Citation
    Allareddy V, Shusterman S, Ross E, Palermo V, Ricalde P. Dentofacial Orthopedics for the Cleft Patient: The Latham Approach. Oral Maxillofac Surg Clin North Am. 2020 May;32(2):187-196. doi: 10.1016/j.coms.2020.01.002. Epub 2020 Feb 17.
    Results Reference
    result
    PubMed Identifier
    8547288
    Citation
    Ball JV, DiBiase DD, Sommerlad BC. Transverse maxillary arch changes with the use of preoperative orthopedics in unilateral cleft palate infants. Cleft Palate Craniofac J. 1995 Nov;32(6):483-8. doi: 10.1597/1545-1569_1995_032_0483_tmacwt_2.3.co_2.
    Results Reference
    result
    PubMed Identifier
    14707617
    Citation
    Berkowitz S, Mejia M, Bystrik A. A comparison of the effects of the Latham-Millard procedure with those of a conservative treatment approach for dental occlusion and facial aesthetics in unilateral and bilateral complete cleft lip and palate: part I. Dental occlusion. Plast Reconstr Surg. 2004 Jan;113(1):1-18. doi: 10.1097/01.PRS.0000096710.08123.93.
    Results Reference
    result
    PubMed Identifier
    28921849
    Citation
    Fuchigami T, Kimura N, Kibe T, Tezuka M, Amir MS, Suga H, Takemoto Y, Hashiguchi M, Maeda-Iino A, Nakamura N. Effects of pre-surgical nasoalveolar moulding on maxillary arch and nasal form in unilateral cleft lip and palate before lip surgery. Orthod Craniofac Res. 2017 Nov;20(4):209-215. doi: 10.1111/ocr.12199. Epub 2017 Sep 18.
    Results Reference
    result
    PubMed Identifier
    21823827
    Citation
    Adali N, Mars M, Petrie A, Noar J, Sommerlad B. Presurgical orthopedics has no effect on archform in unilateral cleft lip and palate. Cleft Palate Craniofac J. 2012 Jan;49(1):5-13. doi: 10.1597/11-030. Epub 2011 Aug 8.
    Results Reference
    result
    PubMed Identifier
    1472517
    Citation
    Mars M, Asher-McDade C, Brattstrom V, Dahl E, McWilliam J, Molsted K, Plint DA, Prahl-Andersen B, Semb G, Shaw WC, et al. A six-center international study of treatment outcome in patients with clefts of the lip and palate: Part 3. Dental arch relationships. Cleft Palate Craniofac J. 1992 Sep;29(5):405-8. doi: 10.1597/1545-1569_1992_029_0405_asciso_2.3.co_2.
    Results Reference
    result
    PubMed Identifier
    18452361
    Citation
    Prahl C, Prahl-Andersen B, Van't Hof MA, Kuijpers-Jagtman AM. Presurgical orthopedics and satisfaction in motherhood: a randomized clinical trial (Dutchcleft). Cleft Palate Craniofac J. 2008 May;45(3):284-8. doi: 10.1597/07-045.1.
    Results Reference
    result
    PubMed Identifier
    33107321
    Citation
    Al Khateeb KA, Fotouh MA, Abdelsayed F, Fahim F. Short-Term Efficacy of Presurgical Vacuum Formed Nasoalveolar Molding Aligners on Nose, Lip, and Maxillary Arch Morphology in Infants With Unilateral Cleft Lip and Palate: A Prospective Clinical Trial. Cleft Palate Craniofac J. 2021 Jul;58(7):815-823. doi: 10.1177/1055665620966189. Epub 2020 Oct 27.
    Results Reference
    result
    PubMed Identifier
    32049908
    Citation
    Gong X, Dang R, Xu T, Yu Q, Zheng J. Full Digital Workflow of Nasoalveolar Molding Treatment in Infants With Cleft Lip and Palate. J Craniofac Surg. 2020 Mar/Apr;31(2):367-371. doi: 10.1097/SCS.0000000000006258.
    Results Reference
    result
    PubMed Identifier
    31795731
    Citation
    Batra P, Gribel BF, Abhinav BA, Arora A, Raghavan S. OrthoAligner "NAM": A Case Series of Presurgical Infant Orthopedics (PSIO) Using Clear Aligners. Cleft Palate Craniofac J. 2020 May;57(5):646-655. doi: 10.1177/1055665619889807. Epub 2019 Dec 4.
    Results Reference
    result

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    Effects of AlignBabyCleft (ABaCleft)

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