Effectiveness of a Novel 3D-Printed Nasoalveolar Molding Appliance (D-NAM) on Improving the Maxillary Arch Dimensions in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial.

OBJECTIVE: The aim of the current study was to introduce and measure the effectiveness of a new 3D-printed nasoalveolar molding (D-NAM) appliance on improving the maxillary arch dimensions (MADs) in infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair. DESIGN: A prospective, balanced, randomized, parallel groups, single-blinded, controlled trial. SETTING: All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt. PARTICIPANTS: Thirty-four, nonsyndromic infants with UCLP. INTERVENTIONS: The eligible infants were randomly assigned into either no-treatment (control) or to the new D-NAM groups. In D-NAM group, the maxillary models were 3D scanned into virtual models onto which segmentation and alveolar segments approximation were performed. Approximation movements were divided into 3 models representing 3 activation steps. On each of these models, virtual appliance construction was performed followed by 3D printing of the appliance. Nasal stent was added manually to the appliances of the second and third steps. Horizontal tapes were applied to infants in the D-NAM group only. MAIN OUTCOMES MEASURES: A Blinded assessors carried all the MADs measurements virtually on digital models collected at the beginning (T1) and after (T2) treatment. RESULTS: Clinically and/or statistically significant improvements in all the measured MADs were recorded in D-NAM group at T2 before surgical lip repair in comparison to control group. CONCLUSIONS: The introduced D-NAM/3D-printed appliance is a simple and efficient technique to improve the MADs in infants with UCLP before surgical lip repair.

Is Taping Alone an Efficient Presurgical Infant Orthopedic Approach in Infants With Unilateral Cleft Lip and Palate? A Randomized Controlled Trial.

OBJECTIVE: The aim of the current randomized controlled trial (RCT) was to assess the effectiveness of taping alone in changing the maxillary arch dimensions (MADs) in infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair. DESIGN: A prospective, balanced, randomized, parallel-group, single-blinded, controlled trial. SETTING: All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt. PARTICIPANTS: Thirty-one, nonsyndromic infants with UCLP. INTERVENTIONS: The eligible infants were randomly assigned to either no-treatment (control) or taping groups. In the taping group, all the infants received horizontal tape between the 2 labial segments aiming to decrease the cleft gap. No other interventions were performed to infants included in this group. Rubber base impressions were made to all the included infants in both groups at the beginning of the treatment (T1) and directly before surgical lip repair (T2). All the produced models were scanned using a desktop scanner producing digital models for outcome assessment. MAIN OUTCOMES MEASURES: A blinded assessor carried out all the MAD measurements virtually on the produced digital models at the beginning (T1) and after (T2) treatment. RESULTS: Clinically and/or statistically significant changes in all the measured MADs were recorded in the taping group at T2 before surgical lip repair in comparison to the control group. CONCLUSIONS: It seems that taping alone is an efficient tool in changing the MADs before surgical lip repair in infants with UCLP.

Does Presurgical Taping Change Nose and Lip Aesthetics in Infants with Unilateral Cleft Lip and Palate? A Randomized Controlled Trial.

BACKGROUND: The aim of this randomized controlled trial was to assess the effectiveness of taping alone in changing nose and lip aesthetics in infants with unilateral complete cleft lip and palate before and after surgical lip repair. METHODS: The study design was a prospective, balanced, randomized, parallel-group, single-blinded, controlled trial. All the steps were carried out in the Department of Orthodontics of Cairo University in Egypt. Thirty-one infants with nonsyndromic unilateral complete cleft lip and palate were randomly assigned to either no treatment (control) or taping groups. In the taping group, all infants received horizontal tape between the two labial segments, aiming to decrease the cleft gap. No other interventions were performed in this group. Standardized photographs and videos were taken of the infants in both groups at the beginning of the treatment (T1), directly before surgical lip repair (T2), and 2 weeks after surgical lip repair (T3). Photographs and shots from videos were calibrated and used for outcome assessment. Blinded assessors carried out all the measurements digitally on the standardized photographs at T1, T2, and T3 using computer software. RESULTS: Significant changes in all the measurements were recorded in the taping group at T2 before surgical lip repair in comparison with the control group. At T3, no differences were found between the two groups. CONCLUSIONS: Taping is a successful intervention in changing nose and lip aesthetics before surgical lip repair. After surgical lip repair, both groups had matching aesthetics. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Cytotoxicity, genotoxicity, and metal release in patients with fixed orthodontic appliances: a longitudinal in-vivo study.

INTRODUCTION: Treatment with fixed orthodontic appliances in the corrosive environment of the oral cavity warrants in-vivo investigations of biocompatibility. METHODS: Eighteen control and 28 treated subjects were evaluated longitudinally. Four combinations of brackets and archwires were tested. Buccal mucosa cell samples were collected before treatment, and 3 and 6 months after appliance placement. The cells were processed for cytotoxicity, genotoxicity, and nickel and chromium contents. RESULTS: In the treatment group, buccal mucosa cell viability values were 8.1% at pretreatment, and 6.4% and 4.5% at 3 and 6 months, respectively. The composite score, a calculated DNA damage value, decreased from 125.6 to 98.8 at 6 months. Nickel cellular content increased from 0.52 to 0.68 and 0.78 ng per milliliter, and chromium increased from 0.31 to 0.41 and 0.78 ng per milliliter at 3 and 6 months, respectively. Compared with the control group, the treated subjects showed significant differences for DNA damage and chromium content at 3 months only. CONCLUSIONS: Fixed orthodontic appliances decreased cellular viability, induced DNA damage, and increased the nickel and chromium contents of the buccal mucosa cells. Compared to the control group, these changes were not evident at 6 months, possibly indicating tolerance for or repair of the cells and the DNA.

Transverse Skeletal Effects of Rapid Maxillary Expansion in Pre and Post Pubertal Subjects: A Systematic Review.

OBJECTIVE: The aim of this systematic review was to assess the transverse skeletal effects of rapid maxillary expansion (RME) in pre and post-pubertal subjects. MATERIAL AND METHODS: Five databases were searched till May 2018; Pubmed, Cochrane, Scopus, Lilacs and Web of science in addition to the manual search of other sources. There were no language restrictions. Methodological Index for Non-Randomized Studies MINORS was used to assess the quality and risk of bias of the trials included. RESULTS: Six studies were finally included in the qualitative analysis. A meta-analysis wasn't performed due to the heterogeneity of methodologies and outcomes. All of the included studies showed drawbacks in their structure yielding weak evidence. On the short term, RME caused an increase in the maxillary and lateral-nasal widths in pre-pubertal subjects by 3.4 mm and 3.3 mm, and by 2.8 and 2.2 mm respectively in post-pubertal subjects. Although statistically insignificant, the maxillary width increase was more than that of the post-pubertal subjects by 0.6 mm. Over the long term, expansion produced permanent increases in the transverse dimensions of both the dento-alveolar and skeletal components of the maxilla and circum-maxillary structures in pre-pubertal subjects. The post-pubertal subjects presented with a statistically significant increase only in the later-nasal width by 1.3 mm than the untreated controls with no permanent increase in the skeletal maxillary width. CONCLUSION: The literature is very deficient regarding the use of skeletal age as a reference in the treatment of skeletal crossbites using RME. Only weak evidence exists supporting the increased maxillary and lateral-nasal widths after tooth-tissue borne RME in pre-pubertal subjects, with these effects being less in the post-pubertal ones.