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).

An In Vivo Study to Compare the Clinical Effectiveness of Clear Retainer Made on a Conventional and a Digitally Fabricated Model Over a Six-Month Period After Debonding.

Background With the advent of 3D printing, many more possibilities have arisen for treatment planning. 3D rapid prototyping has enabled us to see a whole other dimension that has helped us to give the best possible care for our patients. With more and more advancements being made in this subject, it becomes necessary to check the reliability of the equipment and its effectiveness in the management of the problem at hand. This original study was conducted with the aim of checking the accuracy, dimensional stability, and reliability of orthodontic retainers made on a conventional and digitally fabricated model over a six-month period after debonding. Material and methods The patients were selected from those who have completed fixed orthodontic mechanotherapy from the Department of Orthodontics and Dentofacial Orthopaedics, Sri Guru Ram Das Institute of Dental Sciences and Research, Sri Amritsar. Fifty patients received a clear retainer, which was fabricated for the upper and lower arch after removing the brackets. Patients were included in this study irrespective of their age groups. The manual method used a vacuum-forming machine to fabricate six retainers on stone models. In the digital method, new impressions were taken after three months, and digital models were obtained through 3D scanning and printing, followed by clear retainer fabrication. The data were gathered through a systematic process involving manual and digital methods for clear retainer fabrication and subsequent evaluation. The data obtained was computed for statistical evaluation and comparison. Results Mean and standard deviations of conventional (manual) and digital variables in the two groups were calculated. An ANOVA test was used to evaluate statistically significant differences for mesiodistal width and buccolingual width, and a post hoc Tuckey test was applied for multiple comparisons. The results indicated that most mesiodistal and buccolingual width measurements showed non-significant variations and exhibited a good correlation. Extraction space opening, assessed through an independent t-test for both the maxilla and mandible, also yielded non-significant and comparable results. Additionally, intra-operator and inter-operator measurements using a digital caliper demonstrated high agreement. Intra-class correlation (ICC) values exceeded 0.75, and inter-operator ICC results reflected a high level of agreement ranging from 0.8 to 0.99. Conclusion The primary objective of this study was to establish a correlation between the accuracy, dependability, and clinical efficacy of orthodontic retainers produced using both conventional and digitally created models. This investigation spanned a duration of six months following the removal of orthodontic brackets. The results showed that most of the statistically significant values were due to the inherent potential of the 3D printer for polymerization shrinkage, which, being a stereolithographic 3D printer, had a potential for a slight dimensional shift in the transverse dimension. However, the mean difference between all the models printed was slight and clinically insignificant.

The Soft Palate Friendly Speech Bulb for Velopharyngeal Insufficiency.

Velopharyngeal insufficiency is an anatomic defect of the soft palate making palatopharyngeal sphincter incomplete. It is an important concern to address in patients with bilateral cleft lip and palate. Speech aid prosthesis or speech bulbs are best choice in cases where surgically repaired soft palate is too short to contact pharyngeal walls during function but these prosthesis have been associated with inadequate marginal closure, ulcerations and patient discomfort. Here is a case report of untreated bilateral cleft lip and palate associated with palatal insufficiency treated by means of palate friendly innovative speech bulb. This modified speech bulb is a combination of hard acrylic and soft lining material. The hard self-curing acrylic resin covers only the hard palate area and a permanent soft silicone lining material covering the soft palate area. A claw-shaped wire component was extended backwards from acrylic and was embedded in soft silicone to aid in retention and approximation of two materials. The advantage of adding the soft lining material in posterior area helped in covering the adequate superior extension and margins for maximal pharyngeal activity. This also improved the hypernasality, speech, comfort and overall patient acceptance.