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
About this trial
This is an interventional treatment trial for Cleft Lip focused on measuring "cleft lip", " Cleft palate", "presurgical orthopedics"
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.
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
NCT ID
NCT05357092
First Posted
March 22, 2022
Last Updated
April 26, 2022
Sponsor
Universidad Complutense de Madrid
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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