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
Badri Thiruvenkatachari,
Krishnamurthy Bonanthaya,
Anne Marie Kuijpers Jagtman,
Jonathan Sandler,
Rajesh S Powar,
Syed Altaf Hussain,
B. Subramaniyan,
Nitin Bhola,
Hari Kishore Bhat,
Varun Ramachandra,
Sylvia Jayakumar,
Puneet Batra,
Subhiksha Chakkaravarthi,
V. Thailavathy,
Manoj Prathap,
Thulasiram Elumalai,
Karthika Nambiar,
Charanya Vijayakumar,
Ravi Kumar Mahajan,
Sundereshwer Chander Sood,
Sukhdeep Singh Kahlon,
Shruti Bijapur,
Ranjit Haridas Kamble,
K. M. Keluskar,
Amit Nilgar,
Faizan Ahmed Khan,
Devika Das,
Swetha Sridhar,
Adrija Buch,
Shuba Kumar,
Rani Mohanraj,
Stefan Listl,
Samiksha Chopra,
Vikrant Jadhav,
Anika Arora,
Chintan Valiya,
Madhuri Pattamata
Affiliations
Badri Thiruvenkatachari
Cleft and Craniofacial Department, Sree Balaji Dental College and Hospital, Bharath Institute of Higher Education and Research
Krishnamurthy Bonanthaya
Bhagavan Mahaveer Jain Hospital
Anne Marie Kuijpers Jagtman
Department of Orthodontics, University Medical Centre Groningen, University of Groningen
Jonathan Sandler
Chesterfield Royal Hospital, Chesterfield Royal Hospital NHS Foundation Trust
Rajesh S Powar
Jawaharlal Nehru Medical College, KLE Academy of Higher Education and Research
Syed Altaf Hussain
Sree Balaji Medical College and Hospital, Bharath Institute of Higher Education and Research
B. Subramaniyan
Sree Balaji Medical College and Hospital, Bharath Institute of Higher Education and Research
Nitin Bhola
Shri Sharad Pawar Dental College and Hospital (SPDC)
Hari Kishore Bhat
Yenepoya University: Yenepoya (Deemed to Be University)
Varun Ramachandra
Isha Hospital
Sylvia Jayakumar
John’s Research Institute
Puneet Batra
Manav Rachna Dental College
Subhiksha Chakkaravarthi
Cleft and Craniofacial Department, Sree Balaji Dental College and Hospital, Bharath Institute of Higher Education and Research
V. Thailavathy
Cleft and Craniofacial Department, Sree Balaji Dental College and Hospital, Bharath Institute of Higher Education and Research
Manoj Prathap
Cleft and Craniofacial Department, Sree Balaji Dental College and Hospital, Bharath Institute of Higher Education and Research
Thulasiram Elumalai
Cleft and Craniofacial Department, Sree Balaji Dental College and Hospital, Bharath Institute of Higher Education and Research
Karthika Nambiar
Cleft and Craniofacial Department, Sree Balaji Dental College and Hospital, Bharath Institute of Higher Education and Research
Charanya Vijayakumar
Sree Balaji Medical College and Hospital, Bharath Institute of Higher Education and Research
Ravi Kumar Mahajan
Amandeep Hospital
Sundereshwer Chander Sood
Sant Parmanand Hospital
Sukhdeep Singh Kahlon
Amandeep Hospital
Shruti Bijapur
Bhagavan Mahaveer Jain Hospital
Ranjit Haridas Kamble
Shri Sharad Pawar Dental College and Hospital (SPDC)
K. M. Keluskar
Vishwanath Katti Institute of Dental Sciences, KLE Academy of Higher Education & Research
Amit Nilgar
Vishwanath Katti Institute of Dental Sciences, KLE Academy of Higher Education & Research
Faizan Ahmed Khan
Yenepoya University: Yenepoya (Deemed to Be University)
Devika Das
Isha Hospital
Swetha Sridhar
Sree Balaji Medical College and Hospital, Bharath Institute of Higher Education and Research
Adrija Buch
Isha Hospital
Shuba Kumar
Samarth
Rani Mohanraj
Samarth
Stefan Listl
Heidelberg University BIOMS: Universitat Heidelberg Bioquant
Samiksha Chopra
Amandeep Hospital
Vikrant Jadhav
Shri Sharad Pawar Dental College and Hospital (SPDC)
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).
