Towards resorbable 3D-printed scaffolds for craniofacial bone regeneration.

This review will briefly examine the development of 3D-printed scaffolds for craniofacial bone regeneration. We will, in particular, highlight our work using Poly(L-lactic acid) (PLLA) and collagen-based bio-inks. This paper is a narrative review of the materials used for scaffold fabrication by 3D printing. We have also reviewed two types of scaffolds that we designed and fabricated. Poly(L-lactic acid) (PLLA) scaffolds were printed using fused deposition modelling technology. Collagen-based scaffolds were printed using a bioprinting technique. These scaffolds were tested for their physical properties and biocompatibility. Work in the emerging field of 3D-printed scaffolds for bone repair is briefly reviewed. Our work provides an example of PLLA scaffolds that were successfully 3D-printed with optimal porosity, pore size and fibre thickness. The compressive modulus was similar to, or better than, the trabecular bone of the mandible. PLLA scaffolds generated an electric potential upon cyclic/repeated loading. The crystallinity was reduced during the 3D printing. The hydrolytic degradation was relatively slow. Osteoblast-like cells did not attach to uncoated scaffolds but attached well and proliferated after coating the scaffold with fibrinogen. Collagen-based bio-ink scaffolds were also printed successfully. Osteoclast-like cells adhered, differentiated, and survived well on the scaffold. Efforts are underway to identify means to improve the structural stability of the collagen-based scaffolds, perhaps through mineralization by the polymer-induced liquid precursor process. 3D-printing technology is promising for constructing next-generation bone regeneration scaffolds. We describe our efforts to test PLLA and collagen scaffolds produced by 3D printing. The 3D-printed PLLA scaffolds showed promising properties akin to natural bone. Collagen scaffolds need further work to improve structural integrity. Ideally, such biological scaffolds will be mineralized to produce true bone biomimetics. These scaffolds warrant further investigation for bone regeneration.

Orthodontic Localization of Impacted Canines: Review of the Cutting-edge Evidence in Diagnosis and Treatment Planning Based on 3D CBCT Images.

A thorough clinical and radiographical assessment of an impacted maxillary canine's location forms the basis for proper diagnosis and successful treatment outcomes. Implementing a correct biomechanical approach for directing force application primarily relies on its precise localization. Poor biomechanical planning can resorb the roots of adjacent teeth and result in poor periodontal outcomes of the canine that has been disimpacted. Furthermore, treatment success and time strongly rely on an accurate assessment of the severity of impaction, which depends on its 3D spatial location. The evolution of cone-beam computed tomography (CBCT) radiographs provides more detailed information regarding the location of the impacted canines. In addition, the literature has shown that CBCT imaging has enhanced the quality of diagnosis and treatment planning by obtaining a more precise localization of impacted canines. This review article highlights current evidence regarding comprehensive evaluation of three-dimensional orientations of impacted canines on CBCT images for precise diagnosis and treatment planning.

Anterior openbite malocclusion in adults.

OBJECTIVES: To investigate stability and satisfaction in adult anterior open bite (AOB) patients at least 9 months post-treatment, as well as patient and practitioner factors that may be associated with stability and satisfaction. MATERIALS AND METHODS: Practitioners and their adult AOB patients were recruited through the National Dental Practice-Based Research Network. Data on patient and practitioner characteristics, treatment recommendations and factors were previously collected. Treatment stability was determined by assessing post-treatment intraoral photographs. Patient satisfaction was determined from post-treatment questionnaires. Treatment was categorized into aligners, fixed appliances, temporary anchorage devices, and orthognathic surgery. Extractions were also investigated. Retention type was categorized into vacuum-formed, Hawley-style, or bonded retainers, and regimens were classified as full-time or part-time wear. RESULTS: Retention data collected from 112 patients had a mean post-treatment time of 1.21 years. There were no statistically significant differences in stability between treatment groups. Depending on whether a qualitative index or a millimetric measure was employed, stability ranged from 65% to 89%. Extractions and less initial lower incisor proclination were associated with higher stability in patients treated with fixed appliances only. High satisfaction was reported by patients at retention. There were no clear differences in stability or satisfaction among retention types or regimens. CONCLUSIONS: The stability of adult AOB orthodontic treatment was high, regardless of treatment or retainer modality. Satisfaction in adult AOB patients was high, regardless of retention type or regimen.

Orthodontic retention: what's on the horizon?

Orthodontic retention remains one of the great challenges in orthodontics. In this article, we discuss what is on the horizon to help address this challenge, including biological approaches to reduce relapse, treating patients without using retainers, technological developments, personalised medicine and the impact of COVID-19 on approaches to orthodontic retention.

Influence of surgical technique and timing of primary repair on interarch relationship in UCLP: A randomized clinical trial.

OBJECTIVE: To compare dental arch relationships in children with unilateral cleft lip and palate (UCLP) between two surgical techniques for repair of cleft lip/palate and two ages of palate repair. SETTINGS AND SAMPLE: Dental models were taken for a group of 448 subjects at a mean age of 7 years and were evaluated by means of the Goslon Yardstick. The patients studied consisted of an initial group of 673 infants with complete UCLP randomized into 8 study groups according to lip repair procedures (Millard versus Spina techniques); palate repair procedures (von Langenbeck versus Furlow techniques); and palate repair timing (early: 9 to 12 months versus late: 15-18 months). METHODS: Four surgeons performed all surgeries. Dependent variables included the following: lip repair technique, palate repair technique, age at time of palate repair and surgeon; with sex as an independent variable. The data were analysed using a general linear model (P < .05). RESULTS: There were no significant differences for occlusal index scores as a function of lip or palate surgical technique, palatal repair timing and sex. Significant differences were found for occlusal index scores as a function of the surgeon. CONCLUSION: Dental arch relationships were not influenced by lip and palatal repair techniques or patient age at palatal repair. The surgeon was the major factor that influenced the dental arch relationship outcome.

The National Dental Practice-Based Research Network Adult Anterior Open Bite Study: Patient satisfaction with treatment.

INTRODUCTION: This article evaluates and reports on the satisfaction of adult patients across the United States who received orthodontic treatment for anterior open bite malocclusion. The factors that influence satisfaction are also described. METHODS: Practitioners were recruited from the National Dental Practice-Based Research Network. On joining the Network, practitioner demographics and information on their practices were acquired. Practitioners enrolled their adult patients in active treatment for anterior open bite. Patient demographics, patient dentofacial characteristics, and details regarding previous and current treatment were collected through questionnaires at enrollment (T1). Pretreatment lateral cephalograms and intraoral frontal photographs were submitted. Treatment performed, and details related to treatment outcome were recorded through questionnaires at the end of active treatment (T2). Posttreatment lateral cephalograms and intraoral frontal photographs were submitted. Patient satisfaction at T2 was assessed using a 5-point Likert-type scale and open-ended responses. Predictive univariate models were developed to evaluate the factors that affect patient satisfaction. Open-ended responses were reviewed for general trends. RESULTS: T2 data were received for 260 patients, and 248 of these patients completed and returned the patient satisfaction questionnaires. High levels of satisfaction were found in this sample of adult patients receiving treatment for anterior open bite malocclusion. Specifically, 96% of the sample reported being very or somewhat satisfied. Only 10 patients (4%) were not satisfied with the treatment provided or an element of the final result. Successful open bite closure, treatment modality, and certain patient characteristics may affect patient satisfaction. However, there was insufficient power to demonstrate statistical significance because of the very low number of dissatisfied patients. Open-ended responses directly associated with patient satisfaction were received from 23 patients (9%). They relayed positive, neutral, and negative feelings about the treatment received and final results. Additional responses regarding the orthodontic treatment in general, but not specifically linked to patient satisfaction, were received from 119 patients (48%). These comments depict an overwhelmingly positive experience. CONCLUSIONS: Adult patients who received orthodontic treatment for anterior open bite malocclusion were generally satisfied with the treatment provided, as well as the final esthetic and functional results.

The National Dental Practice-Based Research Network Adult Anterior Open Bite Study: Treatment success.

INTRODUCTION: Anterior open bite (AOB) continues to be a challenging malocclusion for orthodontists to treat and retain long-term. There is no consensus on which treatment modality is most successful. This study reports on the overall success rate of AOB orthodontic treatment in the adult population across the United States, as well as 4 major treatment modalities and other factors that may influence treatment success. METHODS: Practitioners and their adult patients with AOB were recruited through the National Dental Practice-Based Research Network. Patient dentofacial and demographic characteristics, practitioner demographic and practice characteristics, and factors relating to orthodontic treatment were reported. Treatment success was determined from posttreatment (T2) lateral cephalometric films and intraoral frontal photographs. Treatment was categorized into 4 main groups: aligners, fixed appliances, temporary anchorage devices (TADs), and orthognathic surgery. Extractions were also evaluated. Bivariate and multivariable models were used to investigate the association between treatment success and treatment modality, pretreatment (T1) dentofacial characteristics, patient and practitioner demographics, and practice characteristics, adjusting for clustering of patients within practice. RESULTS: A total of 254 patients, enrolled by 84 practitioners, contributed to T2 data for this study. There were 29 patients in the aligner group, 152 in fixed appliances, 20 in TADs, and 53 in surgery. A total of 49 patients underwent extractions of teeth other than third molars. Ninety-three percent finished treatment with a positive overbite on the T2 lateral cephalogram, and 84% finished with a positive vertical overlap of all incisors. The small number of aligners and TAD patients limited the ability to compare success rates in these groups. Patients treated with orthognathic surgery had a higher rate of success compared with those treated with fixed appliances only. Treatment success was also associated with academic practice setting, T1 mandibular plane angle ≤30°, no to mild T1 crowding, and treatment duration <30 months. CONCLUSIONS: The overall success of orthodontic treatment in adult patients with AOB who participated in this study was very high. Orthognathic surgery was the only treatment modality that exhibited a statistically higher odds of successful outcomes. Some T1 dentofacial characteristics and treatment factors were associated with the successful closure of AOB.

The National Dental Practice-Based Research Network Adult Anterior Open Bite Study: Treatment recommendations and their association with patient and practitioner characteristics.

INTRODUCTION: This aim of this paper is to describe and identify the practitioner and patient characteristics that are associated with treatment recommendations for adult anterior open bite patients across the United States. METHODS: Practitioners and patients were recruited within the framework of the National Dental Practice-Based Research Network. Practitioners were asked about their demographic characteristics and their treatment recommendations for these patients. The practitioners also reported on their patients' dentofacial characteristics and provided initial cephalometric scans and intraoral photographs. Patients were asked about their demographic characteristics, previous orthodontic treatment, and goals for treatment. Four main treatment groups were evaluated: aligners, fixed appliances, temporary anchorage devices (TADs), and orthognathic surgery. Extractions were also investigated. Predictive multivariable models were created comparing various categories of treatment as well as extraction/nonextraction decisions. RESULTS: Ninety-one practitioners (mostly orthodontists) and 347 patients were recruited from October 2015 to December 2016. Increased aligner recommendations were associated with white and Asian patients, the presence of tongue habits, and female practitioners. TADs were recommended more often in academic settings. Recommendations for orthognathic surgery were associated with demographic factors, such as availability of insurance coverage and practitioner race/ethnicity, and dentofacial characteristics, such as anteroposterior discrepancies, more severe open bites, and steeper mandibular plane angles. Extraction recommendations were largely associated with severe crowding and incisor proclination. CONCLUSIONS: Both doctor and patient demographic factors, as well as dentofacial characteristics, were significantly associated with treatment recommendations for adult anterior open bite patients.

Bis-enoxacin blocks rat alveolar bone resorption from experimental periodontitis.

Periodontal diseases are multifactorial, caused by polymicrobial subgingival pathogens, including Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia. Chronic periodontal infection results in inflammation, destruction of connective tissues, periodontal ligament, and alveolar bone resorption, and ultimately tooth loss. Enoxacin and a bisphosphonate derivative of enoxacin (bis-enoxacin) inhibit osteoclast formation and bone resorption and also contain antibiotic properties. Our study proposes that enoxacin and/or bis-enoxacin may be useful in reducing alveolar bone resorption and possibly bacterial colonization. Rats were infected with 10(9) cells of polymicrobial inoculum consisting of P. gingivalis, T. denticola, and T. forsythia, as an oral lavage every other week for twelve weeks. Daily subcutaneous injections of enoxacin (5 mg/kg/day), bis-enoxacin (5, 25 mg/kg/day), alendronate (1, 10 mg/kg/day), or doxycycline (5 mg/day) were administered after 6 weeks of polymicrobial infection. Periodontal disease parameters, including bacterial colonization/infection, immune response, inflammation, alveolar bone resorption, and systemic spread, were assessed post-euthanasia. All three periodontal pathogens colonized the rat oral cavity during polymicrobial infection. Polymicrobial infection induced an increase in total alveolar bone resorption, intrabony defects, and gingival inflammation. Treatment with bis-enoxacin significantly decreased alveolar bone resorption more effectively than either alendronate or doxycycline. Histologic examination revealed that treatment with bis-enoxacin and enoxacin reduced gingival inflammation and decreased apical migration of junctional epithelium. These data support the hypothesis that bis-enoxacin and enoxacin may be useful for the treatment of periodontal disease.

A better statistical method of predicting postsurgery soft tissue response in Class II patients.

OBJECTIVE: To propose a better statistical method of predicting postsurgery soft tissue response in Class II patients. MATERIALS AND METHODS: The subjects comprise 80 patients who had undergone surgical correction of severe Class II malocclusions. Using 228 predictor and 64 soft tissue response variables, we applied two multivariate methods of forming prediction equations, the conventional ordinary least squares (OLS) method and the partial least squares (PLS) method. After fitting the equation, the bias and a mean absolute prediction error were calculated. To evaluate the predictive performance of the prediction equations, a leave-one-out cross-validation method was used. RESULTS: The multivariate PLS method provided a significantly more accurate prediction than the conventional OLS method. CONCLUSION: The multivariate PLS method was more satisfactory than the OLS method in accurately predicting the soft tissue profile change after surgical correction of severe Class II malocclusions.

Orthodontic tooth movement with clear aligners.

Clear aligners provide a convenient model to measure orthodontic tooth movement (OTM). We examined the role of in vivo aligner material fatigue and subject-specific factors in tooth movement. Fifteen subjects seeking orthodontic treatment at the University of Florida were enrolled. Results were compared with data previously collected from 37 subjects enrolled in a similar protocol. Subjects were followed prospectively for eight weeks. An upper central incisor was programmed to move 0.5 mm. every two weeks using clear aligners. A duplicate aligner was provided for the second week of each cycle. Weekly polyvinyl siloxane (PVS) impressions were taken, and digital models were fabricated to measure OTM. Initial and final cone beam computed tomography (CBCT) images were obtained to characterize OTM. Results were compared to data from a similar protocol, where subjects received a new aligner biweekly. No significant difference was found in the amount of OTM between the two groups, with mean total OTM of 1.11 mm. (standard deviation (SD) 0.30) and 1.07 mm. (SD 0.33) for the weekly aligner and biweekly control groups, respectively (P = 0.72). Over eight weeks, in two-week intervals, material fatigue does not play a significant role in the rate or amount of tooth movement.

A randomized, placebo-controlled clinical trial on the effects of recombinant human relaxin on tooth movement and short-term stability.

INTRODUCTION: Moving teeth rapidly and avoiding posttreatment relapse are fundamental goals of orthodontic treatment. In-vitro and animal studies suggest that the human hormone relaxin might increase the rate of movement and the stability through its effect on the periodontal ligament. The purpose of this study was to compare relaxin and a placebo with regard to tooth movement and stability in human subjects. METHODS: A single-center, blinded, placebo-controlled, randomized clinical trial was used to examine the effect of relaxin on tooth movement and stability. Forty subjects were randomized 1:1 and received weekly injections of 50 µg of relaxin or a placebo for 8 weeks. Aligners programmed to move a target tooth 2 mm during treatment were dispensed at weeks 0, 2, 4, and 6. Movement was measured weekly on polyvinyl siloxane impressions that were scanned and digitized. The subjects were followed through week 12 to assess relapse. RESULTS: Tooth movement over the 8-week treatment period did not differ by treatment group (P = 0.995). By using an intent-to-treat analysis, we found that the mean tooth movement for both groups was 0.83 mm (SE, 0.08 for relaxin and 0.09 for the placebo). Relapse from weeks 8 to 12 was the same in both groups (P = 0.986), and the mean was -0.75 (SE, 0.07 for relaxin and 0.08 for theplacebo). CONCLUSIONS: No differences in tooth movement over 8 weeks of treatment or relapse at 4 weeks posttreatment were detected when comparing subjects who received weekly injections of relaxin with those who received a placebo. In both groups, an average of less than half of the programmed tooth movement was obtained after 8 weeks of treatment. The local doses of relaxin might have been too low to affect tooth movement or short-term relapse.

Intrarater agreement about the etiology of Class II malocclusion and treatment approach.

INTRODUCTION: The management of patients with Class II malocclusion has been an ongoing discussion in orthodontics. The aim of this study was to determine whether orthodontists agree among themselves and with each other about the etiology, timing, and difficulty of treating subjects with Class II malocclusion. METHODS: The initial records of 159 Class II subjects were sent to 8 orthodontists. In this sample, duplicate records of 18 subjects were dispersed. A questionnaire was sent with the records. RESULTS: The intrarater consistency values were 65% when determining the type of malocclusion, 60% when deciding which arch was at fault, and 81% when determining the need for immediate treatment. Consistency values were 33% regarding case difficulty and 77% regarding phase 2 treatment need. There was a significant negative correlation between the consistency of the orthodontists' responses and the peer assessment rating score. CONCLUSIONS: We found that practitioners had only moderate agreement among themselves when diagnosing a patient's type of malocclusion and which arch was at fault when a skeletal discrepancy was noted. Intrarater agreement improved as the peer assessment rating score increased, but the correlation was weak, and this was not consistent for all examiners. Because of insufficient intrarater agreement, interrater agreement was not examined.

Effect of early Class II treatment on the incidence of incisor trauma.

INTRODUCTION: Many researchers have examined the prevalence of dental injuries in children and adolescents. The purpose of this study was to examine the prevalence and incidence of incisor trauma in subjects who participated in a randomized clinical trial designed to investigate early growth modifications in the treatment of Class II malocclusion. METHODS: The subjects were randomized to 3 treatment groups during the initial phase of the study: (1) headgear or biteplane, (2) bionator, and (3) observation (no treatment). All 3 groups underwent phase 2 treatment with fixed appliances. Incisor injury was scored at every data collection point with the Ellis index by a blinded examiner using dental casts, intraoral photos, and panoramic and periapical x-rays. RESULTS: Twenty-five percent of the subjects had incisor trauma at the baseline examination, and 28% experienced new or worsening maxillary incisor injury during the study. No significant differences were found with regard to sex and prevalence of injury at baseline. No differences in incidence of trauma were found between the 3 treatment groups throughout the study (P = 0.19); however, boys were more likely to experience maxillary incisor injury (odds ratio estimate, 2.37; 95% CI, 1.33, 4.21), and those with an injury at baseline were more likely to experience an additional injury (odds ratio estimate, 1.81; 95% CI, 1.03, 3.17). CONCLUSIONS: Early orthodontic treatment did not affect the incidence of incisor injury. The majority of the injuries before and during treatment were minor; therefore, the cost-benefit ratio of orthodontic treatment primarily to prevent incisor trauma is unfavorable.

Relationship of body mass index to stability of mandibular advancement surgery with rigid fixation.

INTRODUCTION: Obesity is a growing problem in the United States. We examined patients undergoing orthognathic surgical correction for Class II skeletal malocclusions and assessed outcomes in relation to body mass index. METHODS: The patients (n = 78) were divided into 3 groups (obese, overweight, and normal or thin) based on body mass index score. They were treated with mandibular advancement (mean, 4.9 mm) with rigid fixation and evaluated cephalometrically for postsurgical changes over a 2-year period; a subset of 54 patients was followed for 5 years. RESULTS: Obese and overweight patients experienced relative postsurgical forward movements at B-point (means, 2.6 and 1.0 mm, respectively), whereas the normal or thin patients had relapses (mean, -0.7 mm) over the 2 years. This trend held up at 5 years, with the obese patients experiencing 3 mm of forward movement compared with the normal or thin patients. Potential reasons for this difference in postsurgical response are orthopedic effects of tongue posture and hormonal and biochemical differences caused by obesity. CONCLUSIONS: Obese and overweight patients have different responses to mandibular advancement with rigid fixation compared with normal or thin patients. These data should enable orthodontists and surgeons to more appropriately treat obese patients.

Comparison of arch dimension changes in 1-phase vs 2-phase treatment of Class II malocclusion.

INTRODUCTION: We compared arch dimension changes in 1-phase and 2-phase treatment of Class II malocclusion. This was a prospective randomized clinical trial conducted in the Department of Orthodontics at the University of Florida between 1990 and 2003. METHODS: During phase 1 treatment, 86 subjects were treated with a bionator, 93 were treated with headgear/biteplane, and 81 served as the observation group. For phase 2, all subjects were then treated with full orthodontic appliances. Arch dimensions were followed; maxillary and mandibular alginate impressions were taken at baseline, end of early Class II treatment or observation, beginning of fixed appliance treatment, end of orthodontic treatment, and approximately 3 years posttreatment. Alginate impressions were taken of each dental arch at each data collection point. These were poured in orthodontic stone, trimmed, and photocopied from the occlusal aspect. These images were then scanned and measured. RESULTS: Although differences between the treatment groups were found in both the maxillary and mandibular arches after phase 1, these differences were no longer evident by the end of full orthodontic treatment or after posttreatment retention. CONCLUSIONS: There were no differences in arch dimensions after 1-phase or 2-phase treatment of Class II malocclusion.

Effects of surgical mandibular advancement and rotation on signs and symptoms of temporomandibular disorder: a 2-year follow-up study.

INTRODUCTION: The possible effects of orthognathic surgery on signs and symptoms of temporomandibular disorder (TMD) are still controversial. We prospectively investigated the association between the amount of advancement and rotation of the mandible during bilateral sagittal split osteotomy (BSSO) and the development of TMD signs and symptoms. METHODS: Class II patients (n = 127) received mandibular advancement with BSSO. We used factorial analysis of covariance to assess whether the magnitude (< or > or = 7 mm) and the direction (clockwise or counterclockwise) of the movement were associated with the onset or worsening of TMD signs and symptoms during 2 years of follow-up. RESULTS: Counterclockwise rotation of the mandible was associated with more muscle tenderness, especially in patients receiving long advancements. The combination of long advancement with counterclockwise rotation was also associated with increased joint symptoms. All symptoms declined over the 2-year follow-up period. CONCLUSIONS: Counterclockwise rotation of the mandible is related to a slight increase in muscle symptoms after BSSO. The combination of counterclockwise rotation with long advancement also might increase joint signs and symptoms. All symptomatology tended to decline over time, suggesting that the amount of advancement and mandibular rotation should not be considered as risk factors for the development of TMD in patients without preexisting conditions.

Effect of early treatment on stability of occlusion in patients with Class II malocclusion.

INTRODUCTION: The purpose of this study was to evaluate the effect of early treatment on the stability of occlusion in patients with Class II malocclusions. The peer assessment rating (PAR) index was used to evaluate changes in occlusion after treatment of subjects treated in 1 phase or 2 phases. This study was a prospective, randomized, controlled clinical trial. METHODS: Dental casts were obtained from the participants, who were randomized into 3 phase-1 early treatment groups: bionator, headgear/bite plane, or observation. Phase 2 consisted of continued treatment of the bionator and the headgear/biteplane subjects and comprehensive treatment of the observation subjects. PAR scores were obtained for 208 subjects at end of treatment; 173 (83%) had at least 1 follow-up visit, with a median follow-up time of 5.0 years. PAR scores were calculated for each subject at key treatment and posttreatment time points. Linear mixed-effect models were used to evaluate the impact of phase-1 treatment group, years posttreatment, end of treatment PAR score, and other covariates that could affect stability on the posttreatment PAR score. RESULTS: Factors significantly affecting posttreatment PAR scores were PAR score at end of treatment (P <.0001), years posttreatment (P =.0064), and PAR score at the start of phase 2. Although phase-1 treatment was not statistically significant, those with early treatment had lower PAR scores at the start of phase 2 than the observation subjects (means [SD]: bionator 17.5 [7.4], headgear/biteplane 15.3 [7.0], observation 22.2 [8.6], P <.0001). Thus, early treatment had an indirect effect. CONCLUSIONS: Factors that affect posttreatment PAR score stability include PAR score at the end of treatment, years posttreatment, and PAR score at the start of phase-2 treatment. The early treatment modalities have limited positive impact on posttreatment stability PAR scores in Class II malocclusion patients due to their effect on PAR scores at the start of phase-2 treatment.

Timing of Class II treatment: skeletal changes comparing 1-phase and 2-phase treatment.

INTRODUCTION: Previous studies reported small but significant skeletal changes as a result of early treatment of Class II malocclusion with headgear and functional appliances. In this study, we report on the skeletal changes for 1-phase and 2-phase treatment of Class II malocclusion. METHODS: This was a prospective randomized clinical trial conducted sy the Department of Orthodontics at the University of Florida between 1990 and 2000. A total of 261 subjects demonstrating at least a one half-cusp Class II molar relationship and meeting the inclusion criteria were enrolled in the study and had at least 1 follow-up visit. During phase 1, 86 subjects were treated with a bionator, 95 were treated with a headgear/biteplane, and 80 served as the observation group. For phase 2, all subjects were then treated with full orthodontics appliances. Skeletal changes were monitored with cephalograms taken at baseline, at the end of early Class II treatment or observation baseline, at the beginning of fixed appliances, and at end of orthodontic treatment. RESULTS: Overall skeletal changes at the end of phase 1 treatment were as follows: (1) SNA angle increased in the bionator (0.51) and the observation groups (0.67), whereas it decreased (-0.50) in the headgear/biteplane group; (2) SNB angle increased in the bionator (1.36) and the observation groups (0.84), whereas it remained unchanged (0.19) in the headgear/biteplane group; (3) ANB angle decreased in the bionator (-0.85) and the headgear/biteplane groups (-0.72), and was unchanged in the observation group; and (4) the mandibular plane angle increased (1.30) only in the headgear/biteplane group. By the end of full orthodontic treatment, the skeletal differences in all measurements for all 3 groups were within 1 degrees . Linear regression models showed that, during phase 1, baseline value and treatment group were significant. However, when the entire treatment period was considered, treatment group had no effect. CONCLUSIONS: There is temporary skeletal change as a result of phase I treatment with both appliances but no detectible skeletal difference between 1-phase and 2-phase treatment of Class II malocclusion by the end of full orthodontic treatment.