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.

Autor: Thiruvenkatachari B; 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. badri.t.chari@gmail.com., Bonanthaya K; Bhagavan Mahaveer Jain Hospital, Bangalore, India., Kuijpers Jagtman AM; Department of Orthodontics, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.; Department of Orthodontics and Dentofacial Orthopedics, School of Dental Medicine/Medical Faculty, University of Bern, Bern, Switzerland., Sandler J; Chesterfield Royal Hospital, Chesterfield Royal Hospital NHS Foundation Trust, Calow, England., Powar RS; Jawaharlal Nehru Medical College, KLE Academy of Higher Education and Research, Belagavi, Karnataka, India., Hussain SA; Sree Balaji Medical College and Hospital, Bharath Institute of Higher Education and Research, Chrompet, Chennai, India., Subramaniyan B; Sree Balaji Medical College and Hospital, Bharath Institute of Higher Education and Research, Chrompet, Chennai, India., Bhola N; Shri Sharad Pawar Dental College and Hospital (SPDC), Wardha, Maharashtra, India., Bhat HK; Yenepoya University: Yenepoya (Deemed to Be University), Mangaluru, Karnataka, India., Ramachandra V; Isha Hospital, Vadodara, Gurajat, India., Jayakumar S; John's Research Institute, Bangalore, India., Batra P; Manav Rachna Dental College, Faridabad, Haryana, India., Chakkaravarthi S; 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., Thailavathy V; 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., Prathap M; 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., Elumalai T; 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., Nambiar K; 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., Vijayakumar C; Sree Balaji Medical College and Hospital, Bharath Institute of Higher Education and Research, Chrompet, Chennai, India., Mahajan RK; Amandeep Hospital, Amritsar, Punjab, India., Sood SC; Sant Parmanand Hospital, Delhi, India., Kahlon SS; Amandeep Hospital, Amritsar, Punjab, India., Bijapur S; Bhagavan Mahaveer Jain Hospital, Bangalore, India., Kamble RH; Shri Sharad Pawar Dental College and Hospital (SPDC), Wardha, Maharashtra, India., Keluskar KM; Vishwanath Katti Institute of Dental Sciences, KLE Academy of Higher Education & Research, Belagavi, India., Nilgar A; Vishwanath Katti Institute of Dental Sciences, KLE Academy of Higher Education & Research, Belagavi, India., Khan FA; Yenepoya University: Yenepoya (Deemed to Be University), Mangaluru, Karnataka, India., Das D; Isha Hospital, Vadodara, Gurajat, India., Sridhar S; Sree Balaji Medical College and Hospital, Bharath Institute of Higher Education and Research, Chrompet, Chennai, India., Buch A; Isha Hospital, Vadodara, Gurajat, India., Kumar S; Samarth, Chennai, India., Mohanraj R; Samarth, Chennai, India., Listl S; Heidelberg University BIOMS: Universitat Heidelberg Bioquant, Heidelberg, Germany., Chopra S; Amandeep Hospital, Amritsar, Punjab, India., Jadhav V; Shri Sharad Pawar Dental College and Hospital (SPDC), Wardha, Maharashtra, India., Arora A; Manav Rachna Dental College, Faridabad, Haryana, India., Valiya C; Isha Hospital, Vadodara, Gurajat, India., Pattamata M; Radboud Universiteit Nijmegen: Radboud Universiteit, Nijmegen, The Netherlands.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 Jul 04; Vol. 25 (1), pp. 453. Date of Electronic Publication: 2024 Jul 04.
DOI: 10.1186/s13063-024-08229-z
Abstrakt: 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).
(© 2024. The Author(s).)
Databáze: MEDLINE
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