Evaluation of Facial Esthetics Following NAM Versus CAD/NAM in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial.

OBJECTIVE: The aim is to compare the facial esthetics following nasoalveolar molding (NAM) versus computer-aided design NAM (CAD/NAM) in patients with bilateral cleft lip/palate (CLP). DESIGN: The trial is a randomized comparative trial with a 1:1 allocation ratio. PARTICIPANTS: Thirty infants with bilateral complete cleft lip and palate were recruited. INTERVENTIONS: Patients were randomized between NAM and CAD/NAM groups. The treatment steps described by Grayson were followed for the NAM group. In the CAD/NAM group, digitized maxillary models were made to create a series of modified virtual models, which were used to fabricate the molding plates using 3-dimensional printing technology. The nasal stents were then added to the intraoral plates following the Grayson method. The study lasted for 4 months. MAIN OUTCOMES: The assessment of the changes observed in the interlabial gap and nasolabial esthetics was done using standardized 2-dimensional photographs. The correlation between dental arch changes and extraoral facial esthetics was studied. RESULTS: Both modalities showed improvement in nasolabial esthetics before the lip surgery. No statistically significant difference was found between NAM and CAD/NAM groups in any of the assessed variables. CONCLUSIONS: Both interventions were effective in the management of infants with bilateral CLP.

Binding of the Dual-Action Anti-Parkinsonian Drug AG-0029 to Dopamine D2 and Histamine H3 Receptors: A PET Study in Healthy Rats.

Introduction: Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction and a diverse range of nonmotor symptoms. Functional relationships between the dopaminergic and histaminergic systems suggest that dual-action pharmaceuticals like AG-0029 (D2/D3 agonist/H3 antagonist) could ameliorate both the motor and cognitive symptoms of PD. The current study aimed to demonstrate the interaction of AG-0029 with its intended targets in the mammalian brain using positron emission tomography (PET). Methods: Healthy male Wistar rats were scanned with a small-animal PET camera, using either the dopamine D2/D3 receptor ligand [11C]raclopride or the histamine H3 receptor ligand [11C]GSK-189254, before and after treatment with an intravenous, acute, single dose of AG-0029. Dynamic [11C]raclopride PET data (60 min duration) were analyzed using the simplified reference tissue model 2 (SRTM2) with cerebellum as reference tissue and the nondisplaceable binding potential as the outcome parameter. Data from dynamic [11C]GSK-189254 scans (60 min duration) with arterial blood sampling were analyzed using Logan graphical analysis with the volume of distribution (VT) as the outcome parameter. Receptor occupancy was estimated using a Lassen plot. Results: Dopamine D2/3 receptor occupancies in the striatum were 22.6 ± 18.0 and 84.0 ± 3.5% (mean ± SD) after administration of 0.1 and 1 mg/kg AG-0029, respectively. In several brain regions, the VT values of [11C]GSK-189254 were significantly reduced after pretreatment of rats with 1 or 10 mg/kg AG-0029. The H3 receptor occupancies were 11.9 ± 8.5 and 40.3 ± 11.3% for the 1 and 10 mg/kg doses of AG-0029, respectively. Conclusions: Target engagement of AG-0029 as an agonist at dopamine D2/D3 receptors and an antagonist at histamine H3 receptors could be demonstrated in the rat brain with [11C]raclopride and [11C]GSK-189254 PET, respectively. The measured occupancy values reflect the previously reported high (subnanomolar) affinity of AG-0029 to D2/D3 and moderate (submicromolar) affinity to H3 receptors.

Pharmacokinetic Modeling of [11C]GSK-189254, PET Tracer Targeting H3 Receptors, in Rat Brain.

The histamine H3 receptor has been considered as a target for the treatment of various central nervous system diseases. Positron emission tomography (PET) studies with the radiolabeled potent and selective histamine H3 receptor antagonist [11C]GSK-189254 in rodents could be used to examine the mechanisms of action of novel therapeutic drugs or to assess changes of regional H3 receptor density in animal models of neurodegenerative disease. [11C]GSK-189254 was intravenously administered to healthy Wistar rats (n = 10), and a 60 min dynamic PET scan was carried out. Arterial blood samples were obtained during the scan to generate a metabolite-corrected plasma input function. PET data were analyzed using a one-tissue compartment model (1T2k), irreversible (2T3k) or reversible two-tissue compartment models (2T4k), graphical analysis (Logan and Patlak), reference tissue models (SRTM and SRTM2), and standard uptake values (SUVs). The Akaike information criterion and the standard error of the estimated parameters were used to select the most optimal quantification method. This study demonstrated that the 2T4k model with a fixed blood volume fraction and Logan graphical analysis can best describe the kinetics of [11C]GSK-189254 in the rat brain. SUV40-60 and the reference tissue-based measurements DVR(2T4k), BPND(SRTM), and SUV ratio could also be used as a simplified method to estimate H3 receptor availability in case blood sampling is not feasible.

Evaluation of the Clinical Effectiveness of Nasoalveolar Molding (NAM) Using Grayson Method Versus Computer-Aided Design NAM (CAD/NAM) in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial.

OBJECTIVE: The aim is to compare between the clinical effectiveness of nasoalveolar molding (NAM) versus the computer-aided design NAM (CAD/NAM) in patients with bilateral clefts. DESIGN: The trial is a randomized comparative trial with 1:1 allocation ratio. PARTICIPANTS: Thirty infants with bilateral complete cleft lip and palate were recruited. INTERVENTIONS: Patients were randomized between NAM and CAD/NAM groups. The treatment steps described by Grayson were followed for the NAM group. In the CAD/NAM group, digitized maxillary models were made to create series of modified virtual models which were used to fabricate the molding plates using 3-dimensional printing technology. The nasal stents were then added to the plates following Grayson method. The study lasted for 4 months. MAIN OUTCOMES: The primary outcome was to evaluate the changes in the intersegment cleft gap. Secondary outcomes included the analysis of the maxillary arch in transverse, anteroposterior, and vertical dimensions as well as the premaxillary deviation and rotation. Chair side time was assessed for both methods. RESULTS: Both modalities decreased the intersegment cleft gap. The CAD/NAM plates caused more reduction in the total arch length by 1.99 mm (-3.79 to 0.19, P = .03) as compared to the NAM treatment. No differences were found between groups in the transverse and vertical maxillary arch changes. CONCLUSIONS: Both interventions were effective in narrowing the cleft gap. Similar maxillary changes were found in both groups. The CAD/NAM modality required less chair side time compared to the NAM treatment.

Single-Stage Vascular Repair and Tissue Cover in Complex Ankle Injuries.

Infragenicular arterial trauma with associated soft-tissue defects presents a challenging scenario. Vascular reconstruction along with concurrent tissue cover may be necessary. We present our experience with six vascular injuries with associated tissue loss. There were 3 male and 3 female patients (age range: 4-60 years). Minimum follow-up was for 12 months. All patients survived with satisfactory coverage of the defect. There was one partial necrosis treated conservatively. Satisfactory limb function was observed in all patients. Thus, these injuries may be treated by simultaneous vascular repair and local flap cover. This may help prevent postoperative infection and save the limb.

Effectiveness of Gingivoperiosteoplasty on Alveolar Bone Reconstruction and Facial Growth in Patients With Cleft Lip and Palate: A Systematic Review and Meta-Analysis.

OBJECTIVE: The aim of the systematic review is to evaluate the effects of gingivoperiosteoplasty (GPP) on alveolar bone quality and facial growth in patients with cleft lip and palate (CLP). SEARCH METHODS: Electronic and manual search was done up to October 2017. ELIGIBILITY CRITERIA: Clinical and observational studies that compared GPP to control; patients without GPP evaluated either before or after the age for secondary bone graft (SBG). DATA COLLECTION AND ANALYSIS: Studies selection was done by 2 authors independently. Risk ratio and mean difference with 95% confidence intervals (CIs) were calculated using random-effects models. RESULTS: Thirteen articles were included in the review. All studies were at high risk of bias. Poorer alveolar bone quality was found in the GPP group compared to the SBG group. The pooled data showed a statistically significant increase in the incidence of Bergland type III in the GPP group compared to SBG (risk ratio: 11.51, 95% CI: 3.39-35.15). As for facial growth, GPP group resulted in a more retruded maxillary position (as indicated by "Sella-Nasion-Subspinale" angle [SNA value]) compared to control group by -1.36 (CI: -4.21 to 1.49) and -1.66 (CI: -2.48 to -0.84) when evaluated at 5 and 10 years, respectively. The protocol for presurgical infant orthopedics used in conjunction with the GPP procedure might have affected the results of the alveolar bone and facial growth outcomes. CONCLUSIONS: Definitive conclusions about the effectiveness of GPP cannot be drawn. Very weak evidence indicated that GPP might not be an efficient method for alveolar bone reconstruction for patients with unilateral and bilateral CLP. Gingivoperiosteoplasty surgery could lead to maxillary growth inhibition in patients with CLP.

A Simple Technique to Create Cheek Dimples.

BACKGROUND: Cheek dimple is a commonly requested aesthetic procedure, especially in the Arabian Gulf area. AIM: This work describes the authors' experience in creation of cheek dimples using simple rapid technique. PATIENTS AND METHODS: This study included 116 dimples in 74 patients. The dimple is done through an intraoral stab incision and prolene suture to fix the dermis of the cheek skin to the underlying buccinator muscle. RESULTS: Eighty-six percent of patients had satisfactory results. The most common complications were fading or complete disappearance of the dimple in 14 dimples and infection in 5 patients. CONCLUSIONS: This technique is very simple, very rapid, easy to execute, and gives satisfactory results in up to 86% of patients. This article also highlights the important information that must be discussed with the patients preoperatively.

Comparison of patient acceptance of the Forsus Fatigue Resistant Device with and without mini-implant anchorage: a randomized controlled trial.

INTRODUCTION: The objective of this 2-arm parallel randomized controlled trial was to evaluate patient acceptance of the mini-implant anchored Forsus Fatigue Resistant Device (FFRD) (3M Unitek, Monrovia, Calif). METHODS: The study included 32 skeletal Class II girls. The eligibility criteria included a deficient mandible, a horizontal or neutral growth pattern, an increased overjet, and a full set of erupted permanent teeth. After the leveling and alignment stage, FFRDs and mini-implants were inserted; they were removed after the teeth reached an edge-to-edge incisor relationship. The patients were afterward asked to fill out assessment questionnaires regarding their experience with the FFRD. OUTCOMES: The primary outcome of this study was to assess patient acceptance of the appliance and satisfaction with the results. The secondary outcomes were interference with functional activities, noticeability by others, pain, swelling, gum problems caused by the appliance, and appliance breakage. RANDOMIZATION: Computer random sequence generation was done using block sizes of 6 and 4. Allocation concealment was achieved with sequentially numbered opaque sealed envelopes. BLINDING: Blinding of the clinicians and the patients to the intervention was impossible, but it was done for the outcome assessment and the statistician. RESULTS: The 32 patients were randomly allocated in a 1:1 ratio into 2 groups: 16 patients (mean age, 13.25 ± 1.12 years) received the FFRD alone (FFRD group), and 16 patients (mean age, 13.07 ± 1.41 years) had mini-implants in conjunction with FFRDs (FMI group). No statistically significant differences were reported between the 2 groups regarding ease of appliance insertion, noticeability by others, pain, swelling, effects on eating and speech, and gum bleeding; 100% and 87.5% were satisfied with the results in the FFRD and FMI groups, respectively, with a ridit value of 0.57 (95% confidence interval, 0.43-0.71; P = 0.36). No serious harm was observed other than swelling of the cheeks, which occurred in 4 patients. CONCLUSIONS: There were no significant differences between the patients' acceptance of the FFRD and the mini-implant anchored FFRD. They were highly satisfied with the results. Neither group reported significant functional limitations. REGISTRATION: This trial was not registered. PROTOCOL: The protocol was not published before trial commencement. FUNDING: The study was self-funded by the authors.

Preciseness of artificial intelligence for lateral cephalometric measurements.

BACKGROUND: The aim of the study was to assess the accuracy and efficiency of a new artificial intelligence (AI) method in performing lateral cephalometric radiographic measurements. MATERIALS AND METHODS: A total of 200 lateral cephalometric radiographs were assessed for quality and included. Three methods were used to perform the cephalometric measurements: (1) the AI method using WebCeph software (AssembleCircle Corp., Gyeonggi-do, Republic of Korea), (2) the modified AI method using WebCeph software after manual modification of the landmarks' position, and (3) using OnyxCeph software (Image Instruments GmbH, Chemnitz, Germany) by manual landmark identification and digital measurements generation. The results of the measurements produced by the three methods were compared, in addition to comparing the time required for the measurements' generation required for each method. RESULTS: Statistically significant differences were detected between the measurements resulting from the three used methods. Fewer differences were detected between the modified AI method and the OnyxCeph method. The AI method produced the measurements the fastest followed by the modified AI method and then the OnyxCeph method. CONCLUSIONS: Considering the used AI software, AI followed by manual tuning of the landmarks' position might be an accurate method in lateral cephalometric analysis. AI alone is still not fully reliable at locating the different landmarks on the lateral cephalometric radiographs.

Role of ultrasound elastography in prediction of malignancy in thyroid nodules.

BACKGROUND: Ultrasonography is considered useful to distinguish between solid and cystic thyroid nodules and to stratify a nodule's risk of cancer as low, medium, or high. Ultrasound (US) elastography has been applied to study the hardness/elasticity of nodules to differentiate malignant from benign lesions. Elastography possibly can solve the dilemma in reaching an accurate diagnosis for the cytologically known as indeterminate nodules. AIM: To evaluate the sensitivity and specificity of US elastography in the diagnosis of thyroid cancer. PATIENTS AND METHODS: This prospective study included 40 patients. The total number of nodules was 46, they were all euthyroid. Laboratory investigations were done including FT3, FT4, and TSH to exclude hot nodules. Neck US, US elastography, and fine-needle aspiration were done to all patients, and US elastography scoring system from 1 to 4 was used. RESULTS: Four out of the 46 studied nodules were malignant. The ROC curve for elastography score (E-score) showed high sensitivity, specificity for the diagnosis of malignant thyroid nodules with a cut-off value of E-score 4 and high significance (p<0.001), the area under curve was 0.92. The sensitivity was 75.0% and specificity was 100%. For E-score more than 2, the sensitivity was 100% and specificity was 85.37%. CONCLUSION: US elastography can be used to increase both the sensitivity and the specificity of US for the detection of malignant thyroid nodules, and so it seems to have great potential as a new tool for the diagnosis of thyroid cancer.

Intrauterine ovarian dermoid cyst complicated by torsion: an uncommon presentation of abdominal mass in a neonate.

Fetal ovarian cysts are the most common abdominal masses in the female fetuses and believed to be caused by in utero exposure of fetus to maternal and placental hormones. Majority of them are diagnosed in third trimester and should be distinguished from other causes of abdominal masses of genitourinary and gastrointestinal origin. Once diagnosed serial ultrasound monitoring is recommended to document changes in size or appearance. Complications like torsion or rupture merit careful assessment and surgical intervention to preserve ovarian function and fertility. We report a case of intrauterine ovarian dermoid cyst complicated by torsion, which was diagnosed prenatally on ultrasound as complex cystic lesion within the abdomen.

Anchorage control using miniscrews in comparison to Essix appliance in treatment of postpubertal patients with Class II malocclusion using Carrière Motion Appliance.

OBJECTIVES: To evaluate anchorage control using miniscrews vs an Essix appliance in treatment of Class II malocclusion by distalization using the Carrière Motion Appliance (CMA). MATERIALS AND METHODS: Twenty-four postpubertal female patients with Class II, division 1 malocclusion were randomly distributed into two equal groups. CMA was bonded in both groups, and one group was treated with miniscrews as anchorage (12 patients, mean age = 18.0 years) while the other group was treated with an Essix appliance as anchorage (12 patients, mean age = 17.8 years). For each patient, two cone-beam computed tomographic scans were obtained: one preoperatively and another after completion of distalization. RESULTS: In the Essix appliance group, there was a statistically significant anterior movement (2.2 ± 1.43 mm) as well as proclination of the lower incisor (5.3° ± 4.0°), compared to a nonsignificant anterior movement (0.06 ± 1.45 mm) and proclination (0.86° ± 2.22°) in the miniscrew group. The amount of maxillary molar distalization was higher in the miniscrew group (2.57 ± 1.52 mm) than in the Essix appliance group (1.53 ± 1.11 mm); however, the difference was not statistically significant. CONCLUSIONS: Miniscrews led to a decrease in the amount of anchorage loss in the mandibular incisors, both in terms of anterior movement and proclination.

Serum Estrogen and its Soluble Receptor Levels in Egyptian Patients with Chronic Myeloid Leukemia: A Case-Control Study.

Chronic myeloid leukemia (CML) is a clonal myeloproliferative disorder. CML cells contain a BCR-ABL gene, not typically found in normal cells that produce a protein (BCR-ABL) causing CML cells to proliferate. CML occurs in three phases: chronic, accelerated and blast crisis. Disease staging is primarily based on percent of blasts in the blood and bone marrow. Most cases of CML are diagnosed in chronic phase (CP). The major objective in CML clinical management is to prevent progression from chronic to accelerated and blast crisis phases. While earlier treatments, such as cytoreductive chemo- and interferon therapies increased overall survival rates among patients, the advent of tyrosine-kinase inhibitors (TKIs) have changed the CML treatment landscape. Despite the widespread use of these therapies, there have also been associated side effects that could potentially affect its use. Also it is necessary to avoid all deaths and complications related to the treatment, by limiting as much as possible the side-effects of the treatment while ensuring the compliance of the patients. The aim of this work was to measure the serum estrogen and its soluble receptor levels in patients with chronic myeloid leukemia in order to extrapolate their possible clinical significance. The present study included 40 (20 males and 20 females) healthy volunteers clinically free from any disease, 40 (20 males and 20 females) patients of newly diagnosed CML. Blood samples were collected from all subjects and the level of serum estrogen (E2) and serum soluble estrogen receptor (ER) were measured by enzyme linked immunosorbent assay (ELISA). The level of serum E2 (pg/ml) in both male and female patients groups with CML was significantly higher than in control group. The level of serum ER (ng/ml) in both male and female patients groups with CML was significantly lower than in control group. Estimating the serum level of E2 and soluble ER is of informative diagnostic value. Estimation serum level of E2 and soluble ER in patients with CML is of value in deciding use of antiestrogen as therapeutic target in treatment protocol. Supplementary Information: The online version contains supplementary material available at 10.1007/s12288-021-01451-8.

Dental arch changes after anterior open bite treatment in the mixed dentition produced by miniscrew-supported palatal crib vs conventional fixed palatal crib.

OBJECTIVES: To evaluate the dental arch changes produced by the miniscrew-supported palatal crib (MSPC) and the conventional fixed palatal crib (CFPC) after the treatment of patients with anterior open bite (AOB) attributed to the tongue-thrusting habit in the mixed dentition stage. MATERIALS AND METHODS: A total of 26 children aged 8 to 11 years with an AOB were randomly distributed into two equal groups; the MSPC group was treated using a palatal crib supported by two miniscrews inserted paramedially, whereas the CFPC group was treated using a conventional fixed palatal crib soldered to bands. Digital models were obtained pretreatment and after a follow-up duration of 9 months. RESULTS: The MSPC group included 12 participants (9 girls and 3 boys; mean age, 9.4 ± 0.75 years), and the CFPC group included 12 participants (10 girls and 2 boys; mean age, 9.0 ± 0.73 years). The amount of AOB closure was similar in both groups: 3.97 ± 1.44 mm in the MSPC group and 3.97 ± 0.89 mm in the CFPC group. There was significant mesial movement of the maxillary first molar in the CFPC (-1.42 ± 0.99 mm) compared with the MSPC group (-0.53 ± 0.32 mm). CONCLUSIONS: Both appliances resulted in similar improvement in the amount of AOB closure. There was significantly more mesial movement of the maxillary first molars in the CFPC group compared with the MSPC group.

Kommerell's diverticulum with right-sided aortic arch and anomalous origin of neck vessels: Uncommon imaging finding in neonate with cyanosis.

Kommerell diverticulum is a rare developmental anomaly of aortic arch. It is most frequently seen with right-sided aortic arch and aberrant left subclavian artery or ligamentum arteriosum, which have a significant role in completing a vascular ring. However, aberrant origin of neck vessels along with it is not commonly seen. The signs and symptoms vary depending on the severity. The paediatric patients usually present early due to compression of mediastinal structures such as trachea or oesophagus.

A new approach to produce [18F]MC225 via one-step synthesis, a PET radiotracer for measuring P-gp function.

BACKGROUND: [18F]MC225 is a radiotracer for imaging P-glycoprotein (P-gp) function at the blood-brain barrier. The P-gp function can be altered due to different factors, for instance, decreased P-gp function has been described in patients with Alzheimer's or Parkinson's Disease. The current applied radiosynthesis of [18F]MC225 involves 2 steps, including the distillation of the [18F] fluoroethylbromide intermediate. To develop a more robust synthetic procedure, it is of interest to produce the radiotracer via a 1-step synthesis. The present study describes a new synthetic approach to produce [18F]MC225 via direct 18F-fluorination. Moreover, we also provide the appropriate conditions for the automation of the synthesis. A mesylate precursor was synthesized via a multi-step synthetic route and used for the radiolabeling. The nucleophilic substitution of the mesylate group by [18F] Fluoride was automated in two different synthesis modules: IBA Synthera and Eckert and Ziegler PharmTracer (E&Z). RESULTS: The mesylate precursor was synthesized in 7 steps starting with 5-hydroxy-1-tetralone (commercially available) in practical yields. The stability of the precursor was improved via mesylate salt formation method. The radiolabeling was done by adding the mesylate precursor dissolved in DMF to the dried [18F]KF/K2.2.2 complex and heating at 140 °C for 30 min. Quality control by UPLC confirmed the production of [18F]MC225 with a molar activity (Am) higher than 100 GBq/micromole. The synthesis time in Synthera was 106 min and the product was obtained with a radiochemical purity higher than 95% and RCY of 6.5%, while the production in E&Z lasted 120 min and the product had a lower radiochemical purity (91%) and RCY (3.8%). CONCLUSIONS: [18F]MC225 was successfully produced via a 1-step reaction. The procedure is suitable for automation using commercially available synthesis modules. The automation of the radiosynthesis in the Synthera module allows the production of the [18F]MC225 by a reliable and simple method.

GMP Compliant Synthesis of [18F]Canagliflozin, a Novel PET Tracer for the Sodium-Glucose Cotransporter 2.

Inhibition of the sodium-glucose cotransporter 2 (SGLT2) by canagliflozin in type 2 diabetes mellitus results in large between-patient variability in clinical response. To better understand this variability, the positron emission tomography (PET) tracer [18F]canagliflozin was developed via a Cu-mediated 18F-fluorination of its boronic ester precursor with a radiochemical yield of 2.0 ± 1.9% and a purity of >95%. The GMP automated synthesis originated [18F]canagliflozin with a yield of 0.5-3% (n = 4) and a purity of >95%. Autoradiography showed [18F]canagliflozin binding in human kidney sections containing SGLT2. Since [18F]canagliflozin is the isotopologue of the extensively characterized drug canagliflozin and thus shares its toxicological and pharmacological characteristics, it enables its immediate use in patients.

Three-dimensional dental measurements: An alternative to plaster models.

INTRODUCTION: The aim of this study was to compare the accuracy of dental measurements taken with calipers on plaster dental casts and those from computed tomography scans of the dentition with a dental measurement program. METHODS: The sample consisted of plaster dental models of 34 orthodontic subjects. Dental arch measurements, including mesiodistal widths of teeth, arch widths, arch lengths, arch perimeters, and palatal depths were made with the calipers. The patients were also scanned with computed tomography, and measurements were made digitally with a 3-dimensional-based dental measurements program (3DD, Biodent, Cairo, Egypt). RESULTS: The results showed strong agreement in most measurements between the conventional method and the 3DD in the 3 planes of space. The mesiodistal measurements of the maxillary right and left second premolars, left central incisor, and right first molar, and the mandibular left and right central incisors, right canine, and left first premolar had fair agreement. CONCLUSIONS: Excellent agreement between the measurements with the conventional and 3DD methods in the 3 planes of space was found; 3DD can be an alternative to conventional stone dental models.

Complications encountered during Forsus Fatigue Resistant Device therapy.

INTRODUCTION: Fixed functional appliances are non-compliant solutions to Class II malocclusion treatment. The clinician, however, should be careful of unexpected complications during the therapy. METHODS: 58 female adolescents who presented with Class II malocclusion due to deficient mandible were treated with Forsus Fatigue Resistant Device (FFRD) therapy until an overcorrection to an edge to edge incisor relationship was achieved. RESULTS: Incisor relationship and overjet were corrected successfully in all the subjects. Twenty-two patients had a complications-free treatment, while several complications were encountered with the remaining 36 subjects. In particular, mandibular canine rotation and development of posterior crossbites were the most common complications, with percentages of 51.7% and 25.9% respectively. Other complications included the breakage and shearing of the extraoral tubes of the first molar bands, and excessive intrusion of the upper first molars. CONCLUSIONS: FFRD is an efficient appliance for treatment of Class II malocclusion; however, different complications were encountered during the appliance therapy. A focus on taking precautions and applying preventive measures can help to avoid such problems, reducing the number of emergency appointments and enhancing the treatment experience with the appliance.