A comparative evaluation of presurgical infant orthopedics of modified Grayson's technique with clear aligners incorporating a nasal elevator in patients with unilateral cleft lip and palate.

OBJECTIVE: To assess the differences between 2 methods of presurgical infant orthopedics: the modified Grayson's technique and a new technique using clear aligners in patients with complete unilateral cleft lip and palate. METHODS: For this prospective comparative cohort study, 30 patients were divided into 2 groups: group A (modified Grayson technique) and group B (clear aligner trays), with 15 patients each. Scanned cast measurements were taken before and after treatment and evaluated using an appropriate 3-dimensional software assessing treatment changes in the alveolus (eg, reduction of width between major and minor segment, angulation change of each respective segment [intragroup and intergroup, respectively]). This was supplemented with standardized anterioposterior, Worms-eye view, and profile photographs assessing changes in columellar angle, nostril width, height, nasolabial angle, and soft-tissue cleft gap. Furthermore, the number of visits for each patient group was also tabulated and assessed. The differences were compared using the independent t test and Mann-Whitney U test for the respective parameters. RESULTS: Groups A and B showed similar posttreatment changes, with no overt significant differences. However, there was a statistically significant difference in the number of visits (P <0.05), with group B having much lower visits to the center than group A. The posttreatment values matched previously established growth reference values. The analysis of photographic measurements showed improved nasal asymmetry in both groups without any significant difference. CONCLUSIONS: Because there was no difference in the treatment results between the 2 methods and a reduction in the number of required patient visits, presurgical infant orthopedics via clear aligners could pave the way for a more patient-efficient approach.

OrthoAligner "NAM": A Case Series of Presurgical Infant Orthopedics (PSIO) Using Clear Aligners.

Presurgical infant orthopedics (PSIO) is done to reduce the size of the cleft defect along with improving the arch alignment and nasolabial aesthetics in patients with cleft lip and palate, leading to an improvement of nasolabial aesthetics allowing for a tidier and more aesthetic reparative procedure and postsurgical scar. Since the 2000s, clear aligners have slowly and steadily treaded their way as an acceptable orthodontic modality, with their usage and acceptability increasing considerably over the past decade. Thus, from the knowledge gathered in its 10 years working with 3-dimensional (3-D) diagnosis, treatment planning, and 3-D Printing services, Compass 3D (Belo Horizonte, Brazil) developed the OrthoAligner NAM system. This case series highlights one of the world's first documented cases of PSIO treated with a series of clear aligners.

Comparative assessment of facemask therapy with and without skeletal anchorage in growing Class III patients with unilateral cleft lip and palate (UCLP): A single-center, prospective randomized clinical trial.

OBJECTIVE: The purpose of this study was to evaluate the maxillary protraction effect of facemask therapy with and without skeletal anchorage in growing Class III patients with unilateral cleft lip and palate (UCLP). MATERIALS AND METHODS: Thirty patients (aged 9-13 years) with UCLP having a GOSLON score 3 were selected for this prospective clinical study. The patients were allocated into two groups using computer generated random number table. Group I (facemask therapy along with two I shaped miniplates, FM + MP) and Group II (facemask mask along with tooth-anchored appliance, FM). Skeletal and dental parameters were evaluated on pre- and post-treatment lateral cephalograms and pharyngeal airway on cone-beam computed tomography systems (CBCT) for assessment of the treatment changes. RESULTS: Both methods proved to be effective with statistically significant improvements in skeletal and dental parameters (p < .05). Skeletal parameters (e.g., SNA, convexity-point A, ANB) with the FM + MP group showed greater change compared to those with FM group (SNA, 2.56°; convexity-point A, 1.22°; ANB, 0.35°). Significant proclination of maxillary incisors was observed in the FM group as compared to FM + MP group (U1 to NA, 5.4°; 3.37 mm). A statistically significant increase in pharyngeal airway volume was noted in both groups (p < .05). CONCLUSION: While both therapies are effective in protracting the maxilla in growing patients with UCLP, the FM + MP allows for a greater skeletal correction, minimizing the dental side effects seen with FM therapy alone. Thus, FM + MP appears to be a promising adjunct in reducing the severity of Class III skeletal correction needed in patients with cleft lip and palate (CLP).

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).

Comparison of dentofacial morphology between parents of children with and without craniofacial anomalies using cephalogram imaging.

Objective: To compare cephalometric parameters in parents of children with bilateral cleft lip and palate (BCLP) and parents of children without any craniofacial anomaly. Methods: A sample of 100 sets of parents were segregated into two groups of 50 parents each. The two groups included parents of children with BCLP and the parents of children with no craniofacial anomaly. Lateral cephalograms and postero-anterior (PA) cephalograms were examined for 100 parents of both the BCLP and control group, respectively. Tracings were scrutinized for 34 linear and angular parameters of dentocraniofacial skeleton. Data were analysed using unpaired Student's t-test. Result: Evaluated lateral cephalograms revealed 15 significant parameters in parents of children with BCLP including a significant increase in Ptm-S, maxillary length, SNA, articular angle and gonial angle. A significant decrease was noted in SN length, cranial base flexion, mandibular length, mandibular body length, total facial height, upper facial height, posterior facial height, Y-axis length and soft tissue total anterior facial height. Upon evaluation of PA cephalograms, four significant parameters were found in parents of children with BCLP. Cranial width, bizygomatic width, maxillary width and lateral interorbital width were significantly decreased in the parents of children with BCLP. Conclusion: Distinct dentocraniofacial morphological features have been found in parents of children with BCLP. Evaluation of these features might be the key to predicting the occurrence of clefts in their children and also planning for future linkage analysis studies amongst them.