A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus and palate (NAMUC study): a study protocol for a randomized controlled trial

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Abstract

Background

Cleft lip and palate (CLP) are among the most common congenital anomaly that affects up to 33,000 newborns in India every year. Nasoalveolar moulding (NAM) is a non-surgical treatment performed between 0 and 6 months of age to reduce the cleft and improve nasal aesthetics prior to lip surgery. The NAM treatment has been a controversial treatment option with 51% of the cleft teams in Europe, 37% of teams in the USA and 25 of cleft teams in India adopting this methodology. This treatment adds to the already existing high burden of care for these patients. Furthermore, the supporting evidence for this technique is limited with no high-quality long-term clinical trials available on the effectiveness of this treatment.

Method

The NAMUC study is an investigator-initiated, multi-centre, single-blinded randomized controlled trial with a parallel group design. The study will compare the effectiveness of NAM treatment provided prior to lip surgery against the no-treatment control group in 274 patients with non-syndromic unilateral complete cleft lip and palate. The primary endpoint of the trial is the nasolabial aesthetics measured using the Asher McDade index at 5 years of age. The secondary outcomes include dentofacial development, speech, hearing, cost-effectiveness, quality of life, patient perception, feeding and intangible benefits. Randomization will be carried out via central online system and stratified based on cleft width, birth weight and clinical trial site.

Discussion

We expect the results from this study on the effectiveness of treatment with NAM appliance in the long term along with the cost-effectiveness evaluation can eliminate the dilemma and differences in clinical care across the globe.

Trial registration

ClinicalTrials.gov CTRI/2022/11/047426 (Clinical Trials Registry India). Registered on 18 November 2022. The first patient was recruited on 11 December 2022. CTR India does not pick up on Google search with just the trial number. The following steps have to be carried out to pick up.

How to search: ( https://ctri.nic.in/Clinicaltrials/advsearch.php—use the search boxes by entering the following details: Interventional trial > November 2022 > NAMUC).

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-024-08229-z.

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Most cited references 25

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Incidence of cleft lip, cleft palate, and cleft lip and palate among races: a review.

Apostole P Vanderas (1987)

A review of the literature pertaining to the incidence of cleft lip, cleft palate, and cleft lip and palate in different races is presented. The studies have been evaluated according to the method used to record the incidence rate. Half of the studies include in their base population livebirths, stillbirths, and abortions, or livebirths and stillbirths to record the incidence rate. In addition, in most of the studies, clefts with associated malformations and possible syndromes are included in the reported incidence. There is evidence, however, to suggest that the risk of developing clefts in stillbirths and abortions is three times as frequent as in livebirths and that clefts with associated malformations behave differently epidemiologically from clefts without associated malformations. It is suggested, therefore, that the incidence of cleft lip, cleft palate, and cleft lip and palate should be studied separately for each group, namely for livebirths, stillbirths, and abortions and should be reported separately for clefts without associated malformations, clefts with associated malformations, and syndromes. More research is needed to study the risk of developing clefts among the various groups that exhibit different epidemiologic behavior for each race.

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The Eurocleft project 1996-2000: overview.

W Shaw, G Semb, Pierre Nelson … (2001)

The original Eurocleft project, a European intercentre comparison study, revealed dramatic differences in outcome, which were a powerful stimulus for improvement in the services of respective teams. The study developed a preliminary methodology to compare practices and the potential for wider European collaboration including opportunities for the promotion of clinical trials and intercentre comparison was recognized by the European Commission. Therefore, the project: 'Standards of Care for Cleft Lip and Palate in Europe: Eurocleft' ran between 1996 and 2000 and aimed to promote a broad uplift in the quality of care and research in the area of cleft lip and palate.

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Is Open Access

Addressing the challenges of cleft lip and palate research in India

Peter Mossey, Julian Little (2009)

The Indian sub-continent remains one of the most populous areas of the world with an estimated population of 1.1 billion in India alone. This yields an estimated 24.5 million births per year and the birth prevalence of clefts is somewhere between 27,000 and 33,000 clefts per year. Inequalities exist, both in access to and quality of cleft care with distinct differences in urban versus rural access and over the years the accumulation of unrepaired clefts of the lip and palate make this a significant health care problem in India. In recent years the situation has been significantly improved through the intervention of Non Governmental Organisations such as SmileTrain and Transforming Faces Worldwide participating in primary surgical repair programmes. The cause of clefts is multi factorial with both genetic and environmental input and intensive research efforts have yielded significant advances in recent years facilitated by molecular technologies in the genetic field. India has tremendous potential to contribute by virtue of improving research expertise and a population that has genetic, cultural and socio-economic diversity. In 2008, the World Health Organisation (WHO) has recognised that non-communicable diseases, including birth defects cause significant infant mortality and childhood morbidity and have included cleft lip and palate in their Global Burden of Disease (GBD) initiative. This will fuel the interest of India in birth defects registration and international efforts aimed at improving quality of care and ultimately prevention of non-syndromic clefts of the lip and palate.

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Author and article information

Contributors

Badri Thiruvenkatachari:

ORCID: http://orcid.org/0000-0002-7809-8111

badri.t.chari@gmail.com

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 4 July 2024

Publication date PMC-release: 4 July 2024

Publication date Collection: 2024

Volume: 25

Electronic Location Identifier: 453

Affiliations

[1 ]GRID grid.416254.0, ISNI 0000 0004 0505 0832, Cleft and Craniofacial Department, , Sree Balaji Dental College and Hospital, Bharath Institute of Higher Education and Research, ; Velachery Main Road, Chennai, Tamil Nadu 600100 India

[2 ]Bhagavan Mahaveer Jain Hospital, ( https://ror.org/058wvcm81) Bangalore, India

[3 ]GRID grid.4830.f, ISNI 0000 0004 0407 1981, Department of Orthodontics, , University Medical Centre Groningen, University of Groningen, ; Groningen, The Netherlands

[4 ]Department of Orthodontics and Dentofacial Orthopedics, School of Dental Medicine/Medical Faculty, University of Bern, ( https://ror.org/02k7v4d05) Bern, Switzerland

[5 ]GRID grid.413868.0, ISNI 0000 0004 0417 2571, Chesterfield Royal Hospital, Chesterfield Royal Hospital NHS Foundation Trust, ; Calow, England

[6 ]GRID grid.414956.b, ISNI 0000 0004 1765 8386, Jawaharlal Nehru Medical College, , KLE Academy of Higher Education and Research, ; Belagavi, Karnataka India

[7 ]GRID grid.444347.4, ISNI 0000 0004 1796 3866, Sree Balaji Medical College and Hospital, Bharath Institute of Higher Education and Research, ; Chrompet, Chennai, India

[8 ]Shri Sharad Pawar Dental College and Hospital (SPDC), ( https://ror.org/05wnp6x23) Wardha, Maharashtra India

[9 ]Yenepoya University: Yenepoya (Deemed to Be University), ( https://ror.org/029zfa075) Mangaluru, Karnataka India

[10 ]Isha Hospital, Vadodara, Gurajat India

[11 ] John’s Research Institute, Bangalore, India

[12 ]Manav Rachna Dental College, Faridabad, Haryana India

[13 ]Amandeep Hospital, Amritsar, Punjab India

[14 ]Sant Parmanand Hospital, ( https://ror.org/03x295n29) Delhi, India

[15 ]Vishwanath Katti Institute of Dental Sciences, KLE Academy of Higher Education & Research, ( https://ror.org/013x70191) Belagavi, India

[16 ]Samarth, Chennai, India

[17 ]Heidelberg University BIOMS: Universitat Heidelberg Bioquant, ( https://ror.org/038t36y30) Heidelberg, Germany

[18 ]Radboud Universiteit Nijmegen: Radboud Universiteit, ( https://ror.org/016xsfp80) Nijmegen, The Netherlands

Author information

Badri Thiruvenkatachari http://orcid.org/0000-0002-7809-8111

Article

Publisher ID: 8229

DOI: 10.1186/s13063-024-08229-z

PMC ID: 11223389

PubMed ID: 38965585

SO-VID: 388f58f0-b40d-450a-acad-67e1a6a8c3b8

License:

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 25 May 2024

Date accepted : 4 June 2024

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100009053, The Wellcome Trust DBT India Alliance;

Award ID: IA/CPHS/20/1/505255

Award Recipient : Badri Thiruvenkatachari

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ScienceOpen disciplines: Medicine

Keywords: randomized controlled trials,cleft lip and palate,nasoalveolar moulding,nam treatment,clp,psio,presurgical infant orthopaedics

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ScienceOpen disciplines: Medicine

Keywords: randomized controlled trials, cleft lip and palate, nasoalveolar moulding, nam treatment, clp, psio, presurgical infant orthopaedics

A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus and palate (NAMUC study): a study protocol for a randomized controlled trial

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Abstract

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Discussion

Trial registration

Supplementary Information

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Karger: Nephrology

Most cited references 25

Incidence of cleft lip, cleft palate, and cleft lip and palate among races: a review.

The Eurocleft project 1996-2000: overview.

Addressing the challenges of cleft lip and palate research in India

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