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Computer-aided design and computer-aided manufacturing (CAD/CAM) technology has been implemented in the treatment of cleft lip and palates (CLP) by several research groups. This pilot study presents a technique that combines intraoral molding with a semi-automated plate generation and 3D-printing. The clinical results of two intraoral molding approaches are compared. This is the first clinical investigation of semi-automated intraoral molding. Our study included newborns with unilateral CLP. Plaster models were digitalized and measured by two independent observers. Two methods of CAD/CAM-assisted intraoral molding were compared: (i) stepwise manual design of molding plates (conventional CAD/CAM-intraoral molding) and (ii) a semi-automated approach with an automated detection of alveolar ridges (called RapidNAM) assisted by a graphical user interface (GUI). Both approaches significantly narrowed the clefts and resulted in a harmonic alveolar crest alignment. The GUI was easy to use and generated intraoral molding devices within minutes. The presented design solution is an efficient technical refinement with good clinical results. The semi-automated plate generation with a feasible GUI is fast but allows individual adaptations. This promising technique might facilitate and foster the more widespread use of CAD/CAM-technology in intraoral molding therapy.

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).

Objectives The purpose of this “two-arm parallel” trial was to compare the orthopedic, dental, and alveolar bone plate changes of slow (SME) and rapid (RME) maxillary expansions in patients with complete bilateral cleft lip and palate (BCLP). Material and methods Forty-six patients with BCLP and maxillary arch constriction in the late mixed dentition were randomly and equally allocated into two groups. Computer-generated randomization was used. Allocation was concealed with sequentially, numbered, sealed, opaque envelopes. The SME and RME groups comprised patients treated with quad-helix and Haas/Hyrax-type expanders, respectively. Cone-beam computed tomography (CBCT) exams were performed before expansion and 4 to 6 months post-expansion. Nasal cavity width, maxillary width, alveolar crest width, arch width, palatal cleft width, inclination of posterior teeth, alveolar crest level, and buccal and lingual bone plate thickness were assessed. Blinding was applicable for outcome assessment only. Interphase and intergroup comparisons were performed using paired t tests and t tests, respectively ( p  < 0.05). Results SME and RME similarly promoted significant increase in all the maxillary transverse dimensions at molar and premolar regions with a decreasing expanding effect from the dental arch to the nasal cavity. Palatal cleft width had a significant increase in both groups. Significant buccal inclination of posterior teeth was only observed for RME. Additionally, both expansion procedures promoted a slight reduction of the alveolar crest level and the buccal bone plate thickness. Conclusions No difference was found between the orthopedic, dental, and alveolar bone plate changes of SME and RME in children with BCLP. Both appliances produced significant skeletal transverse gains with negligible periodontal bone changes. Treatment time for SME, however, was longer than the observed for RME. Clinical relevance SME and RME can be similarly indicated to correct maxillary arch constriction in patients with BCLP in the mixed dentition.

ObjectiveThis prospective controlled study evaluated the effect of bone-anchored maxillary protraction therapy in cleft children with Class III malocclusion using CBCT-derived 3D surface models.Materials and subjectsEighteen cleft patients between 10 and 12 years old were included. Intermaxillary elastics were worn after the placement of four zygoma bone plates for 18 months. Uniquely, three age-matched untreated groups including both cleft subjects and non-cleft subjects with Class III malocclusion served as controls. Profile photos and CBCT scans for each patient were taken before (T0) and 18 months after the protraction (T1). 3D measurements were made on CBCT surface models from the treatment group using tomographic color mapping method. Cephalometric measurements were made on lateral cephalogram reconstructed from the CBCT scans and were compared with those obtained from the control groups.ResultsTwo thirds of the treatment subjects showed improved lip projection towards more convex facial profile. The most significant skeletal changes on 3D surface models were observed at the zygomatic regions (mean 1.5-mm forward, downward, and outward displacement) and at the maxillary complex (mean 1.5-mm forward displacement). Compared with the control groups, the treatment subjects showed significant increase in the SNA and ANB angles, increased Wits appraisal, a more forward movement of point A and overjet improvement (p < 0.05).ConclusionsBAMP in cleft patients gives a significant forward displacement of the zygomaxillairy complex in favor of the Class III treatment.Clinical relevanceThis treatment method shows clearly favorable outcome in cleft patients after 1.5 years of BAMP.

Objectives This study aimed to compare the 3D changes of maxillary arches in infants with bilateral cleft lip and palate (BCLP) undergoing vacuum formed nasoalveolar molding appliance with active screw (VF-NAM) to those who received conventional Grayson (G-NAM). Methods A total of 24 BCLP infants were randomly allocated into, group 1 ( n  = 12) who received V-NAM and Group 2 ( n  = 12) underwent G-NAM appliances. In the V-NAM group, all infants received 1- 2 vacuum formed maxillary plates incorporated with active retraction screw. In the G-NAM group, Grayson’s NAM technique was followed. The nasal stents were added to the maxillary plates in both groups in the same manner to mold the deformed nasal cartilages. Sixteen items in the digital maxillary models were analyzed at T1 (pre-NAM therapy) and T2 (post-NAM therapy) using 3D software. Parametric data were analyzed using a repeated measures ANOVA test to compare between groups and assess changes within each group by time, while non-parametric data were analyzed using the Mann–Whitney U test to compare between groups and the Wilcoxon signed-rank test to assess changes within each group by time. Results By the end of this study, both groups showed no statistically significant differences in all variables associated with changes in the transverse and vertical arch dimensions except the mid-arch width in which the VF-NAM group exhibited a significantly greater change compared to the G-NAM group, with an effect size of 0.953 (CI 95%: -0.03 − 2.46). In the sagittal dimensions, A more significant decrease in the right and left alveolar cleft widths was observed in the VF-NAM group relative to the G-NAM group with effect sizes of 0.89 (CI 95%: -3.73–0.11). and 0.85 (CI 95%: -3.82 − 0.14), respectively ( P  < 0.05). Conversely, the G-NAM group demonstrated a significantly greater increase in the premaxillary rotation angle compared to the VF-NAM group, with an effect size of 0.875(CI 95%: -3.06 − 13.56) ( P  < 0.05). Conclusion Both VF-NAM and G-NAM effectively reduced alveolar cleft gaps, retracted the premaxillary segment, and normalized alveolar contour. However, VF-NAM resulted in greater reductions in cleft width and mid-arch width expansion. Conversely, G-NAM was more effective in improving premaxillary rotation. These findings may contribute to clinical decision-making in the early cleft management by guiding the selection of appliances based on individual anatomical characteristics. The use of a VF-NAM or G-NAM appliance could strategically optimize pre-surgical outcomes and enhance treatment planning in infants with BCLP. Trial registration NCT04966572 -July 8th 2021.

Objective The objective of the study is to evaluate the skeletal, dentoalveolar and soft tissue changes before and after treatment with Alt-RAMEC protocol and protraction headgear in comparison to the controls. Material and methods A quasi experimental study was conducted in the orthodontic department on 60 patients of cleft lip and palate. These patients were divided into two groups. Group I was the Alt-RAMEC group that underwent Alt-RAMEC protocol followed by facemask therapy while group II was the control group that underwent RME and facemask therapy. Total treatment time in both the groups was approximately 6 to 7 months. Mean and standard deviation was calculated for all the quantitative variables. Pre and post treatment changes between treatment and control groups were made using paired t-test. Intergroup comparison between treatment and control group was analyzed using independent t-test. Significance for all tests was predetermined at a P -value of  ≤ 0.05. Results The Alt-RAMEC group showed significant forward movement of maxilla and improvement in the maxillary base. A remarkable improvement in SNA was seen. The overall outcome was better maxillo-mandibular relationship as shown by positive ANB values and angle of convexity. More effect on maxilla and least effect on mandible was notified with Alt-RAMEC protocol and facemask therapy. Improvement in transverse relationship was also evident in the Alt-RAMEC group. Conclusion Alt-RAMEC protocol in combination with protraction headgear is a better alternative to treat cleft lip and palate patients in comparison to the conventional protocol.

Objective A long-term evaluation to assess the transverse dental arch relationships at 9 and 12 years of age in unilateral cleft lip and palate treated with or without infant orthopedics (IO). The hypothesis is that IO has no effect on the transverse dental arch relationship. Material and methods A prospective two-arm randomized controlled trial (DUTCHCLEFT) in three academic cleft palate centers (Amsterdam, Nijmegen and Rotterdam, the Netherlands). Fifty-four children with complete unilateral cleft lip and palate and no other malformations were enrolled in this evaluation. One group wore passive maxillary plates (IO+) during the first year of life, and the other group did not (IO−). Until the age of 1.5, all other interventions were the same. Hard palate was closed simultaneously with bone grafting according to protocol of all teams. Orthodontic treatment was performed when indicated. The transverse dental arch relationship was assessed on dental casts using the modified Huddart/Bodenham score to measure the maxillary arch constriction at 9 and 12 years of age. Results No significant differences were found between the IO+ and IO− groups. Differences between the centers increased from 9 to 12 years of age. Conclusions Transverse dental arch relationships at 9 and 12 years of age do not differ between children with UCLP treated with or without IO. Clinical relevance There is no orthodontic need to perform IO as applied in this study in children with UCLP.

Objective: To evaluate longitudinally the effect of infant orthopedics (IO) on dentofacial cephalometric variables in unilateral cleft lip and palate (UCLP) patients from 4 to 6 years of age. Design: Prospective two-arm randomized controlled clinical trial in three cleft palate centers in The Netherlands (Dutchcleft trial). Patients: Fifty-four children with complete UCLP. Interventions: Patients were divided randomly into two groups. Half of the patients (IO+) had IO until surgical closure of the soft palate at the age of ±52 weeks; the other half (IO−) received no intervention. Mean Outcome Measures: Cephalometric values representing soft tissue, hard tissue, and dental structures, measured on lateral headfilms made at 4 and 6 years of age. Results: In the IO+ group, 21 patients were analyzed; in the IO− group, 20 patients were analyzed at age 4 and 22 at age 6. No differences were found between IO+ and IO−, except for two measurements: The interincisal angle was larger and the mentolabial angle was smaller in the IO+ group. Conclusions: For infants with UCLP whose surgical management included soft palate repair at 12 months and delayed hard palate closure, cephalometric outcomes at ages 4 and 6 provide no indication for the type of IO used in this study.

Objective: Evaluation of the effect of infant orthopedics on maxillary arch dimensions in the deciduous dentition in patients with unilateral cleft lip and palate. Design: Prospective two-arm randomized controlled clinical trial with three participating cleft palate centers. Setting: Cleft palate centers of the Radboud University Nijmegen Medical Center, Academic Center of Dentistry Amsterdam, and University Medical Center Rotterdam, the Netherlands. Patients: Children with complete unilateral cleft lip and palate (n = 54) were included. Interventions: Patients were randomly divided into two groups. Half of the patients (IO+) had a presurgical orthopedic plate until surgical closure of the soft palate at the age of 52 weeks; the other half (IO−) did not undergo presurgical orthopedics. Mean outcome measures: Maxillary arch dimensions were assessed on dental casts at 4 and 6 years of age with measurements for arch width, arch depth, arch length, arch form, and the vertical position of the lesser segment. Contact and collapse were assessed also. Results: There were no clinically significant differences found between IO+ and IO− for any of the variables. Conclusions: Infant orthopedics had no observable effect on the maxillary arch dimensions or on the contact and collapse scores in the deciduous dentition at the ages of 4 and 6 years. Considering the Dutchcleft results to date, there is no need to perform infant orthopedics for unilateral cleft lip and palate patients.

Objective: To study the effect of infant orthopedics on facial appearance. Design: Prospective two-arm randomized controlled trial in parallel with three participating academic cleft palate centers. Treatment allocation was concealed and performed by means of a computerized balanced allocation method. Setting: Cleft Palate Centers of Amsterdam, Nijmegen, and Rotterdam, the Netherlands. Patients: Infants with complete unilateral cleft lip and palate, no other malformations. Interventions: One group (IO+) wore passive maxillary plates during the first year, the other group (IO−) did not. Main Outcome Measure(s): Two metrical response modalities were used (i.e., visual analog scales and reference scores) to score facial appearance. Full face and cropped photographs were compared with reference photographs and were judged. The photographs were judged by 45 judges, 24 laypeople, and 21 professionals. Transformation of the scores into z scores was applied to compare and to pool both response modalities. The validity of each individual judge was evaluated, as was the reliability of the scales. Differences between the treatment groups were evaluated by means of t tests. Results: Photographs were available of 41 subjects, 21 with and 20 without infant orthopedics. No significant differences were found between groups. Mean z-score values for the full-face photographs were: group IO+ = 0.10 (SD = 0.73) and group IO− = −0.03 (SD = 0.48); for the cropped photographs were: group IO+ = 0.12 (SD = 0.71) and group IO− = −0.06 (SD = 0.55). Conclusions: Infant orthopedics have no effect on facial appearance.