Cleft Lip(ABaCleft)NCT05357092
Effects of AlignBabyCleft (ABaCleft)
A study testing Appliance. Orthodontic appliance to carry out dentoalveolar movement in people with Cleft Lip and Cleft Palate, run by Universidad Complutense de Madrid.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 days to 1 month
- Conditions the study is for
- Cleft Lip, Cleft Palate
- What is being tested?
- Appliance. Orthodontic appliance to carry out dentoalveolar movement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 21 Nov 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cleft Lip, Cleft Palate
- Being tested
- Appliance. Orthodontic appliance to carry out dentoalveolar movement
- Keywords
- "cleft lip", " Cleft palate", "presurgical orthopedics"
- Medical subject headings
- Cleft Lip, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appliance. Orthodontic appliance to carry out dentoalveolar movementDevice
Also called Clear Aligners
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Device: Appliance. Orthodontic appliance to carry out dentoalveolar movement |
| Gold Standard | No intervention | The reference therapeutic action (no pre-surgical orthopedic intervention previous to primary lip surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year ( Primary completion)
Secondary outcomes (1)
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.
Measured: 1 year ( primary completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start21 Nov 2025 (estimated)
- Primary completion21 Nov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cleft LipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROSA YAÑEZ VICO, Study director, COMPLUTENSE UNIVERITY OF MADRID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357092
- Sponsor's protocol ID
- The 360º Cleft Project -ABa
- Acronym
- (ABaCleft)
- Status last verified
- Nov 2024
- First submitted
- 22 Mar 2022
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32081579Ball 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.
PubMed 8547288Berkowitz 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.
PubMed 14707617Fuchigami 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.
PubMed 28921849Adali 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.
PubMed 21823827Mars 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.
PubMed 1472517Prahl 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.
PubMed 18452361Al 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.
PubMed 33107321Gong 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.
PubMed 32049908Batra 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.
PubMed 31795731
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Presurgical Orthopedics in Patients With Cleft Lip and/or Palate, a Randomized Controlled Clinial Trial.
- ClinicalTrials.gov ID
- NCT05357092
- Acronym / sponsor ID
- (ABaCleft) / The 360º Cleft Project -ABa
- Conditions
- Cleft Lip, Cleft Palate
- Keywords
- "cleft lip", " Cleft palate", "presurgical orthopedics"
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 21 Nov 2025 (estimated)
- Primary completion
- 21 Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Appliance. Orthodontic appliance to carry out dentoalveolar movementPatients 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. |
| Gold Standard | No intervention | –The reference therapeutic action (no pre-surgical orthopedic intervention previous to primary lip surgery) |
Who may qualify
- Ages
- 7 days to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Appliance. Orthodontic appliance to carry out dentoalveolar movementAlso: Clear AlignersA 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. | Device | Intervention group |
Primary outcome
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 secondary outcome
Positive aspects for caregivers
Time frame: 1 year ( primary completion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Results publication: PubMed 32081579Allareddy 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 publication: PubMed 8547288Ball 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 publication: PubMed 14707617Berkowitz 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 publication: PubMed 28921849Fuchigami 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 publication: PubMed 21823827Adali 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 publication: PubMed 1472517Mars 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 publication: PubMed 18452361Prahl 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 publication: PubMed 33107321Al 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 publication: PubMed 32049908Gong 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 publication: PubMed 31795731Batra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ROSA YAÑEZ VICO study director
COMPLUTENSE UNIVERITY OF MADRID
Questions about this trial
What is this clinical trial studying?
A study testing Appliance. Orthodontic appliance to carry out dentoalveolar movement in people with Cleft Lip and Cleft Palate, run by Universidad Complutense de Madrid.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ROSA YAÑEZ VICO (913941982 ext. 913941982, rosayanez@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter arch dimensions (time frame: 1 year ( Primary completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05357092, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.