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.

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).

Riga-Fede Disease Associated with Syndactyly and Oligodactyly: A rare Occurrence.

Background: Eruption of first primary tooth starts on an average at around six to seven months of age. Presence of teeth at birth or within a month after birth is considered rare. Natal teeth are those present in the oral cavity at the time of birth. These teeth can cause ulcers on the ventral surface of the tongue, lip, and the mother's breast characterizing the Riga Fede Disease. Exact aetiology of natal and neonatal teeth is still unclear. The treatment depends on its mobility of teeth as it is associated with the risk of aspiration or swallowing, whether the natal tooth is supernumerary or primary, causing any problems in breast feeding, presence of soft tissue injuries on tongue of the child or mother's breast and overall health of child. Case presentation: A fifteen day old girl reported with large ulceration on ventral surface of tongue due to sharp natal teeth present at mandibular anterior region which was also associated with feeding difficulties. Along with Riga Fede disease Syndactyly and Oligodactyly in left and right legs respectively was also observed. Extraction of the teeth has been carried out and complete healing of ulceration has been achieved within 30 days. Conclusion: The present case report describes a rare occurrence of Riga Fede disease with Syndactyly and Oligodactyly and highlights its symptomatology and therapeutic approach.