Outcome assessment of orthodontic clear aligner vs fixed appliance treatment in adolescents with moderate to severe malocclusions.

OBJECTIVE: To compare the efficacy and efficiency of treatment with clear aligners (CAT) vs fixed appliances (FAT) in adolescents with Class I and II moderate to severe malocclusions. MATERIALS AND METHODS: One operator's (Garfinkle) cases from 2014 to 2019, started at age 12-18 years, with pre- and posttreatment records were identified and used according to an institutional review board-approved protocol. Records were measured by two calibrated, blinded investigators, aided by software (OrthoCAD [Cadent, Fairview, N.J.], Dolphin Imaging & Management Solutions [Chatsworth, Calif]). Discrepancy index (DI) and cast radiograph evaluation (CRE) scores, treatment duration, number of scheduled and emergency visits, and reported appliance and interarch elastic wear compliance were compared between groups using Wilcoxon rank sum and Fisher's exact tests. Cephalometric superimpositions were completed to evaluate craniofacial growth and dental changes. RESULTS: Records from 72 cases met the criteria and were included. For the 47 CAT and 25 FAT cases, mean DI (21 ± 5 and 24 ± 8, respectively; P = .20) and CRE (35 ± 10 and 34 ± 9, respectively; P = .90) scores were not significantly different. Other case attributes and reported appliance and interarch elastic wear compliance were also not significantly different. CAT vs FAT cases had significantly smaller treatment durations (24 ± 6 vs 27 ± 5 months; P = .01) and visit numbers (16 ± 5 vs 24 ± 4; P < .01), but emergency visit numbers were not significantly different (2 ± 2 vs 3 ± 2; P = .08). CONCLUSIONS: In adolescents with Class I and II malocclusions and moderate to severe DI scores, on average, CAT vs FAT cases were completed 3 months faster with eight fewer visits, but treatment efficacy was not significantly different.

Outcome assessment of orthodontic clear aligner vs fixed appliance treatment in a teenage population with mild malocclusions.

OBJECTIVE: To assess the efficacy and efficiency of treatment in adolescents presenting with mild malocclusions, comparing outcomes using clear aligners to fixed appliances. MATERIALS AND METHODS: Patients identified retrospectively and consecutively from one private practice had been treated with either clear aligners (Invisalign, Align Technology, Santa Clara, Calif) or fixed appliances (0.022 Damon, Ormco, Orange, Calif; n = 26/group). Assessments of occlusion were made using the American Board of Orthodontics Discrepancy Index (DI) for initial records and Cast-Radiograph Evaluation (CRE) for final records. Number of appointments, number of emergency visits, and overall treatment time were determined from chart reviews. Data were analyzed using Pearson's correlation, Wilcoxon rank tests, unpaired t-tests, and Chi-square tests, with significance set to P ≤ .05. RESULTS: Pretreatment, the aligner and fixed groups showed no significant difference in overall severity (DI: 11.9 ± 5.3 vs 11.6 ± 4.8) or in any individual DI category. Posttreatment scores showed finishes for the aligner group had fewer discrepancies from ideal relative to the fixed appliance group (CRE: 30.1 ± 8.3 vs 37.0 ± 9.3; P < .01). Patients treated with aligners had fewer appointments (13.7 ± 4.4 vs 19.3 ± 3.6; P < .0001), fewer emergency visits (0.8 ± 1.0 vs 3.6 ± 2.5; P < .0001), and shorter overall treatment time (16.9 ± 5.7 vs 23.4 ± 4.4 months; P < .0001). CONCLUSIONS: Outcomes for treatment of mild malocclusions in adolescents showed equivalent effectiveness of clear aligners compared to fixed appliances, with significantly improved results for clear aligner treatment in terms of tooth alignment, occlusal relations, and overjet. Assessment of the number of appointments, number of emergency visits, and overall treatment time showed better outcomes for treatment with clear aligners.

Early Weight Gain in Infants With Cleft Lip and Palate Treated With and Without Nasoalveolar Molding: A Retrospective Study.

OBJECTIVE: To assess weight gain of infants with cleft lip and/or palate (CL ± P) treated with nasoalveolar molding (NAM). DESIGN: Retrospective, case-control chart review. SETTING: Doernbecher Children's Hospital, Oregon Health & Science University, Portland, Oregon. PATIENTS, PARTICIPANTS: Infants with nonsyndromic CL ± P and noncleft controls. INTERVENTIONS: Prior to primary lip surgery, NAM was either included (+NAM) or not included (-NAM) in the cleft treatment protocol. MAIN OUTCOME MEASURE(S): Weight gain and percentage weight gain relative to initial weight were compared among +NAM, -NAM, and control groups from birth to 7 months and from birth to 36 months. RESULTS: Comparing +NAM and -NAM groups, no significant difference in weight or percentage weight gain was found in either time window. Compared to controls, from birth to 7 months, both CL ± P groups weighed less (P < .001), while percentage weight gain was greater for the +NAM (P < .001) and did not differ for -NAM. From birth to 36 months relative to controls, weight for +NAM showed no significant difference and -NAM weighed less (P < .01), while percentage weight gain was greater for both CL ± P groups (P < .001). CONCLUSIONS: Comparisons of CL ± P infants treated with and without NAM showed that with the NAM appliance, despite its added complexity, there was no adverse impact on weight gain. Comparisons to noncleft, control infants suggests that NAM treatment may have a beneficial impact on weight gain.

Factors Associated With Adherence to Nasoalveolar Molding (NAM) by Caregivers of Infants Born With Cleft Lip and Palate.

OBJECTIVE: Identify factors associated with adherence to nasoalveolar molding (NAM) therapy. DESIGN: Retrospective case-control study. SETTING: Tertiary referral center. PATIENTS, PARTICIPANTS: Infants with cleft lip, with or without cleft palate, referred for NAM. One hundred thirty-five patients met criteria. MAIN OUTCOME MEASURE(S): Adherence to NAM therapy, defined as continuous use of the appliance and attendance of NAM adjustment visits. RESULTS: Female sex (OR = 2.85, 95% CI 1.21-6.74), bilateral cleft (OR = 2.88, 95% CI 1.29-6.46), and travel distance (OR = 1.01, 95% CI 1.00-1.01) were independent predictors of nonadherence. Bilateral clefts (OR = 8.35, 95% CI 2.72-25.64) and public-payer insurance (OR = 3.67, 95% CI 1.13-11.91) for male patients were significantly associated with nonadherence, in our sex-stratified multivariate model. The majority of the families (58%) had public health insurance. Males comprised 77.0% of the cohort. CONCLUSIONS: NAM treatment adherence is impaired by bilateral clefts, female sex, increased travel distance, and public insurance. Further studies are warranted to investigate how these factors affect adherence, and to develop interventions to improve adherence in families at risk due to economic or psychosocial barriers.

Surgeon's and Caregivers' Appraisals of Primary Cleft Lip Treatment with and without Nasoalveolar Molding: A Prospective Multicenter Pilot Study.

BACKGROUND: Despite the increasing use of nasoalveolar molding in early cleft treatment, questions remain about its effectiveness. This study examines clinician and caregiver appraisals of primary cleft lip and nasal reconstruction with and without nasoalveolar molding in a nonrandomized, prospective, multicenter study. METHODS: Participants were 110 infants with cleft lip/palate (62 treated with and 48 treated without nasoalveolar molding) and their caregivers seeking treatment at one of six high-volume cleft centers. Using the Extent of Difference Scale, standard photographs for a randomized subset of 54 infants were rated before treatment and after surgery by an expert clinician blinded to treatment group. Standard blocked and cropped photographs included frontal, basal, left, and right views of the infants. Using the same scale, caregivers rated their infants' lip, nose, and facial appearance compared with the general population of infants without clefts before treatment and after surgery. Multilevel modeling was used to model change in ratings of infants' appearance before treatment and after surgery. RESULTS: The expert clinician ratings indicated that nasoalveolar molding-treated infants had more severe clefts before treatment, yet both groups were rated equally after surgery. Nasoalveolar molding caregivers reported better postsurgery outcomes compared with no-nasoalveolar molding caregivers (p < 0.05), particularly in relation to the appearance of the nose. CONCLUSIONS: Despite having a more severe cleft before treatment, infants who underwent nasoalveolar molding were found by clinician ratings to have results comparable to those who underwent lip repair alone. Infants who underwent nasoalveolar molding were perceived by caregivers to have better treatment outcomes than those who underwent lip repair without nasoalveolar molding. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

A 12-year anthropometric evaluation of the nose in bilateral cleft lip-cleft palate patients following nasoalveolar molding and cutting bilateral cleft lip and nose reconstruction.

BACKGROUND: Patients with bilateral cleft lip-cleft palate have nasal deformities including reduced nasal tip projection, widened ala base, and a deficient or absent columella. The authors compare the nasal morphology of patients treated with presurgical nasoalveolar molding followed by primary lip/nasal reconstruction with age-matched noncleft controls. METHODS: A longitudinal, retrospective review of 77 nonsyndromic patients with bilateral cleft lip-cleft palate was performed. Nasal tip protrusion, alar base width, alar width, columella length, and columella width were measured at five time points spanning 12.5 years. A one-sample t test was used for statistical comparison to an age-matched noncleft population published by Farkas. RESULTS: All five measurements demonstrated parallel, proportional growth in the treatment group relative to the noncleft group. The nasal tip protrusion, alar base width, alar width, columella length, and columella width were not statistically different from those of the noncleft, age-matched control group at age 12.5 years. The nasal tip protrusion also showed no difference in length at 7 and 12.5 years. The alar width and alar base width were significantly wider at the first four time points. CONCLUSIONS: This is the first study to describe nasal morphology following nasoalveolar molding and primary surgical repair in patients with bilateral cleft lip-cleft palate through the age of 12.5 years. In this investigation, the authors have shown that patients with bilateral cleft lip-cleft palate treated at their institution with nasoalveolar molding and primary nasal reconstruction, performed at the time of their lip repair, attained nearly normal nasal morphology through 12.5 years of age.

Documentation of the incidents associated with mandibular distraction: introduction of a new stratification system.

BACKGROUND: This article aims to assess the spectrum of unfavorable events or incidents encountered during mandibular distraction and to evaluate the difference in the incident rates among the following treatment groups: (1) native bone distraction using an external device, (2) native bone distraction using an internal device, and (3) grafted bone distraction using an external device. METHODS: This retrospective study examined the records of 141 patients treated by mandibular distraction over a 16-year period. Of the total 141 patients, 56 underwent unilateral mandibular distraction and 85 underwent bilateral mandibular distraction, contributing to a total of 226 sided distraction procedures. The number of procedures performed on native bone using external devices was 149, versus 41 internal devices. There were 36 distractions performed on grafted bone with external devices. Incidents were broadly classified into three groups based on a severity index. A minor incident was one that resolved satisfactorily with minimal or no invasive intervention. A moderate incident was one that resolved satisfactorily with moderate clinical intervention. A major incident was one that did not resolve or could not be resolved with surgical intervention, and compromised treatment outcome. RESULTS: The major incident rate was 5.31 percent (total of 226 distraction procedures). A higher rate of major incidents was observed when distracting grafted bone. The overall minor incident rate was 26.99 percent and the moderate incident rate was 20.35 percent. CONCLUSION: Mandibular distraction can be considered a safe and predictable procedure for lengthening/augmenting the mandible in patients with lower jaw deficiencies.

Nasoalveolar molding improves appearance of children with bilateral cleft lip-cleft palate.

BACKGROUND: Bilateral cleft lip-cleft palate is associated with nasal deformities typified by a short columella. The authors compared nasal outcomes of cleft patients treated with banked fork flaps to those of patients who underwent nasoalveolar molding and primary retrograde nasal reconstruction. METHODS: A retrospective review of 26 consecutive patients with bilateral cleft lip-cleft palate was performed. Group 1 patients (n = 13) had a cleft lip repair and nasal correction with banked fork flaps. Group 2 patients (n = 13) had nonsurgical columellar elongation with nasoalveolar molding followed by cleft lip closure and primary retrograde nasal correction. Group 3 patients (n = 13) were age-matched controls. Columellar length was measured at presentation and at 3 years of age. The number of nasal operations was recorded to 9 years. The Kruskal-Wallis and Tukey-Kramer tests were used for statistical analysis. RESULTS: Initial columellar length was 0.49 +/- 0.37 mm in group 1 and 0.42 +/- 0.62 mm in group 2. Post-nasoalveolar molding columellar length was 4.5 +/- 0.76 mm in group 2. By 3 years of age, columellar length was 3.03 +/- 1.47 mm in group 1, 5.98 +/- 1.09 mm in group 2, and 6.35 +/- 0.99 mm in group 3. Group 2 columellar length was significantly greater (p < 0.001) than that of group 1 and not statistically different from that of group 3 (p > 0.05). All group 1 patients (13 of 13) needed secondary nasal surgery. No nasoalveolar molding patients (zero of 13, group 2) required secondary nasal surgery. CONCLUSION: Nonsurgical columellar elongation with nasoalveolar molding followed by primary retrograde nasal reconstruction restored columellar length to normal by 3 years and significantly reduced the need for secondary nasal surgery.

The importance of vector selection in preoperative planning of bilateral mandibular distraction.

BACKGROUND: The application of distraction osteogenesis is an effective treatment for mandibular deficiencies. A priori, a horizontal vector of distraction was hypothesized to produce horizontal movement of the mandible and a vertical vector of distraction to produce primarily downward vertical elongation of the ramus. This study was designed to test this hypothesis. METHODS: A retrospective clinical and radiographic review was conducted of all patients who underwent bilateral, uniplanar distraction with an external device at the New York University Medical Center between October of 1990 and February of 2004 (n = 185). A subset of 15 patients was identified who satisfied inclusion criteria and had adequate predistraction and postdistraction lateral cephalograms. Cephalometric tracings were made and multiple landmarks were assessed before and after distraction. RESULTS: A strong correlation was noted between the vector of distraction and rotation of the symphyseal plane, movement of the mandibular symphysis, and change in interocclusal angle. A horizontal vector of distraction resulted in minimal counterclockwise rotation of the symphyseal plane, greater downward vertical translation of the mandibular symphysis, and minimal closure of an anterior open bite. In contrast, a vertical vector resulted in greater counterclockwise rotation of the symphyseal plane, greater horizontal projection of the mandibular symphysis, and greater closure of an anterior open bite. Mathematical formulas were derived to correlate the distraction vector and mandibular movements. CONCLUSIONS: Successful distraction is dependent on accurate prediction of outcomes. This study demonstrates that the vector of distraction predictably affects the mandibular response during bilateral distraction osteogenesis but contradicts the a priori hypothesis.

The importance of vector selection in preoperative planning of unilateral mandibular distraction.

BACKGROUND: Unilateral craniofacial microsomia is characterized by soft-tissue and bony deficiencies. Mandibular distraction osteogenesis can be used to augment the hypoplastic skeleton and improve facial symmetry. The aim of this study was to determine how the vector of unilateral mandibular distraction affects treatment outcomes. METHODS: A retrospective chart and radiographic review was conducted of all patients treated with external mandibular distraction osteogenesis between October of 1990 and February of 2004 (n = 185). A subset of 42 patients underwent primary unilateral, uniplanar, external distraction, and 13 patients were found to have satisfied inclusion criteria and had adequate predistraction and postdistraction lateral and posteroanterior cephalograms. Cephalometric tracings were made and multiple points and planes were assessed before and after distraction. RESULTS: A strong correlation was noted between the vector of distraction and the movement of the mandible. A horizontal vector of distraction resulted in minimal increase in ramal length but a marked shift in the mandibular midline (r = 0.68, p < 0.05). In contrast, a vertical vector of distraction resulted in marked mandibular ramus lengthening but minimal mandibular midline shift (r = 0.73, p < 0.05). Mathematical formulas were derived to correlate the distraction vector and mandibular movements to improve preoperative planning. CONCLUSIONS: Successful distraction is dependent on accurate preoperative planning and prediction of outcomes. This study demonstrates a predictable relationship between the vector of unilateral distraction and the mandibular response.

Evaluation of orthodontic mini-implant anchorage in premolar extraction therapy in adolescents.

INTRODUCTION: The purpose of this study was to determine the success rate, positional stability, and patient evaluation of orthodontic mini-implants (OMIs). METHODS: Thirteen patients (8 girls, 5 boys; average age, 14 years 10 months) were treated with 82 OMIs measuring 1.6 mm in diameter and 6 mm in length placed in the buccal alveoli (1 unloaded OMI and 1 loaded OMI per quadrant). The right or left side of each arch was randomly selected for immediate loading with up to 250 g of direct force; the contralateral side was loaded 3 to 5 weeks later. Serial impressions, clinical observations, and orthodontic maintenance were performed until adequate space closure was achieved. RESULTS: The overall OMI success rate was 70.73%. As calculated with a mixed-model analysis, there was no statistically significant difference between the success rates of immediately loaded OMIs (80.0%) and delayed loaded OMIs (80.95%). The combined success rate for loaded OMIs (80.49%) was significantly higher than that of unloaded OMIs (60.98%). Patients' motivation for OMI treatment was primarily the desire to avoid headgear. Using a 100-mm visual analog scale, the patients indicated average scores of 54.77 for the amount of pain during OMI placement and 27.10 for the amount of pain during OMI removal. CONCLUSIONS: OMIs are a predictable, effective, and well-tolerated anchorage source for adolescents. Neither the timing of force application nor the force itself precipitated failure of the OMIs. Orthodontic forces can be applied immediately to OMIs. Various anatomic and behavioral conditions unique to adolescents and a clinical learning curve can affect the success rate of OMIs.

Success rate of gingivoperiosteoplasty with and without secondary bone grafts compared with secondary alveolar bone grafts alone.

BACKGROUND: Gingivoperiosteoplasty has been shown to eliminate the need for secondary alveolar bone grafting in 60 percent of patients. The purpose of this study was to compare radiographic alveolar anatomy following infant gingivoperiosteoplasty, secondary alveolar bone grafting, and secondary alveolar bone grafting in patients who had prior infant gingivoperiosteoplasty with inadequate bone formation. METHODS: Seventy-four consecutive nonsyndromic patients (complete bilateral cleft lip-cleft palate, n = 12; complete unilateral cleft lip-cleft palate, n = 46; complete unilateral cleft lip and alveolus, n = 14) treated at New York University Medical Center were available for evaluation. Eighty-two complete alveolar cleft sites were assigned to three groups: gingivoperiosteoplasty (n = 30), secondary alveolar bone grafting (n = 41), and secondary alveolar bone grafting following gingivoperiosteoplasty (n = 11). All gingivoperiosteoplasties were performed at the time of primary lip surgery, and secondary alveolar bone grafting (cancellous iliac crest at 7 to 12.5 years of age) was performed before eruption of the permanent canine. Radiographs were measured according to the modified method of Long. RESULTS: Seventy-three percent of gingivoperiosteoplasty cases did not require secondary alveolar bone grafting and none had fistulas. The rate of missing teeth in the total sample, adjacent to the cleft, was within normal limits for the population. Group 1 alone and groups 1 and 3 combined had superior alveolar anatomy compared with group 2 (p < 0.01). No significant differences existed between groups 1 and 3 (p > 0.05). Crest height was best in group 1 (p < 0.01), followed by group 3 and then group 2, with no difference between the latter two groups. CONCLUSION: Gingivoperiosteoplasty alone or combined with secondary alveolar bone grafting results in superior bone levels when compared with conventional secondary alveolar bone grafting alone.