RESUMEN
BACKGROUND: Maxillary bonded and removable retainers maintain teeth in correct positions following orthodontic treatment. There is insufficient evidence regarding the capacity of the retention methods to stabilize the maxillary teeth both during and after retention. OBJECTIVE: To evaluate retention capacity and 1-year post-retention changes in the irregularity of maxillary anterior teeth and single anterior tooth contact point discrepancy (CPD) of two bonded and one removable retention method. TRIAL DESIGN: Three-arm parallel group single-centre randomized controlled trial. METHODS: Ninety adolescent patients treated with fixed orthodontic appliances were enrolled. After gaining informed consent, the patients were randomized in blocks of 30 by an independent person into one of three groups: A) bonded retainer 13-23; B) bonded retainer 12-22; and C) removable vacuum-formed retainer. The primary outcomes were changes in Little's irregularity index (LII) and single CPD measured on digitalized casts before retention (T1), after 2 years of retention (T2), and 1-year post-retention (T3). BLINDING: The digital casts were blinded for the outcome assessor. RESULTS: Data on all 90 patients were analysed according to intention-to-treat principles. Changes in LII during retention were 0.3 mm in group A, 0.6 mm in group B, and 1.0 mm in group C. No significant differences between the groups were seen (P > 0.05). Changes during post-retention were 1.1 mm in group A, 0.5 mm in group B, and 0.4 mm in group C. Group A showed more significant changes than groups B and C (P = 0.003). During the whole post-treatment period, no significant differences were shown between the groups (P > 0.05). CPD did not differ significantly between the groups at any point. HARMS: Three patients showed changes of LII over 3 mm or CPD over 2 mm during the post-retention period, and two accepted to be realigned. LIMITATIONS: The trial was a single-centre study evaluating 1-year post-retention changes. CONCLUSIONS: The changes were clinically insignificant during and after the retention period. Thus, all three methods showed equal retention capacity. TRIAL REGISTRATION: www.clinicaltrials.com (NCT04616755).
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Retenedores Ortodóncicos , Ortodoncia Correctiva , Humanos , Adolescente , Vacio , Diseño de Aparato Ortodóncico , Aparatos Ortodóncicos FijosRESUMEN
BACKGROUND: There has been an increased interest in conducting healthcare economic evaluations. Also, orthodontic treatments have gathered focus from an economic point of view, however orthodontic research seldom examines both clinical and economic outcomes. OBJECTIVE: To evaluate and compare the costs of three retention methods: a bonded retainer to the maxillary four incisors, a bonded retainer to the maxillary four incisors and canines, and a removable vacuum-formed retainer (VFR) in the maxilla. The null hypothesis was that there was no difference in costs for the three types of retention methods. TRIAL DESIGN: Three-arm, parallel group, single-centre, randomized controlled trial. MATERIALS AND METHODS: Ninety adolescent patients, 54 girls and 36 boys, treated with fixed or removable retainers in the maxilla, were recruited to the study. The patients were randomized in blocks of 30, by an independent person, to one of three groups: bonded multistranded PentaOne (Masel Orthodontics) retainer 13-23, bonded multistranded PentaOne (Masel Orthodontics) retainer 12-22, and removable VFR. A cost analysis was made regarding chair time costs based on the costs per hour for the specialist in orthodontics, and material costs plus any eventual costs for repairs of the appliance. Changes in Little's irregularity index and in single contact point discrepancies (CPDs) were measured on digitalized three-dimensional study casts. Data were evaluated on an intention-to-treat basis. The analysis was performed at 2 years of retention. RESULTS: No statistically significant difference in costs between the maxillary fixed retainers and the VFRs was found, however, the material and emergency costs were significantly higher for the VFR compared with the bonded retainers. All three retention methods showed equally effective retention capacity, and no statistically significant differences in irregularity or CPDs of the maxillary anterior teeth in the three groups was detected. LIMITATIONS: It was a single-centre trial, and hence less generalizable. Costs depended on local factors, and consequently, cannot be directly transferred to other settings. CONCLUSIONS: All three retention methods can be recommended when considering costs and retention capacity. TRIAL REGISTRATION: NCT04616755.
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Maxilar , Retenedores Ortodóncicos , Adolescente , Costos y Análisis de Costo , Femenino , Humanos , Masculino , Diseño de Aparato Ortodóncico , Aparatos Ortodóncicos Fijos/economía , Retenedores Ortodóncicos/economía , Ortodoncia Correctiva/economía , VacioRESUMEN
OBJECTIVES: To compare the costs and treatment effects of headgear activator treatment of Class II malocclusion with excessive overjet between treatments started in the mixed (MD) and late mixed dentition (LMD). TRIAL DESIGN: Two-arm parallel-group single-centre randomized controlled trial (RCT). MATERIAL AND METHODS: A total of 56 children presenting Class II malocclusion with excessive overjet were assessed and invited to an RCT designed as intention-to-treat. The children were randomized, by an independent person not involved in the trial into two groups, treatment with headgear activator in the MD starting at the age of 9 or to treatment with a headgear activator in LMD, starting at the age of 11. The primary outcome measure was to compare the treatment costs between the two groups. Societal costs (the sum of direct and indirect costs) were calculated for successful treatments only and when unsuccessful treatments were included. Secondary outcomes were comparisons of oral health-related quality of life (OHRQoL), dental and skeletal treatment effects, lip closure, and trauma incidence. Data collections were performed before and after treatment, corresponding to a treatment period of 2 years. Blinding was accomplished when assessing outcomes. RESULTS: No group differences in costs were found of successful treatments or when unsuccessful treatments were included. The most pronounced treatment effects in both groups were the reduction of overjet and improved molar relation. Treatment started in MD or in LMD were equal and without significant differences regarding effects on OHRQoL, skeletal effects, lip closure, and incidence of trauma. HARMS: No harm was observed, but 8 of 30 children (27%) in the MD and 6 of 21 children (29%) in the LMD group showed unsuccessful results. LIMITATIONS: Costs depend on local factors and can thereby not be directly transferred to other settings. It was a single-centre trial and can thus be less generalizable. CONCLUSIONS: Regarding costs and treatment effects, there is no difference if headgear activator treatment of excessive overjet starts in the MD or LMD. CLINICAL TRIAL REGISTRATION: NCT04508322.
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Maloclusión Clase II de Angle , Sobremordida , Niño , Costos y Análisis de Costo , Dentición Mixta , Humanos , Maloclusión Clase II de Angle/terapia , Boca , Sobremordida/terapiaRESUMEN
Esthetics in the oro-facial region are important for perceived oral health and a common reason for treatment of discoloured, missing or crowded teeth. As one of the fundamental bricks of a patient's oral health, changes in the domain of oro-facial esthetics resides within the oral health-related quality of life (OHRQoL) of an individual. Four main dimensions, oral function, oro-facial pain, oro-facial appearance and psychosocial impact, are suggested to cover the concept of OHRQoL. The aim of this systematic review was to map the impact from oral conditions with principal impact on the oro-facial appearance dimension of OHRQoL (PROSPERO: CRD42017064033). Publications were included if they reported Oral Health Impact Profile (OHIP) mean or median domain scores for patients with esthetic treatment need relating to tooth wear, orthodontics, orthognathic surgery, frontal tooth loss or tooth whitening. A search in PubMed (Medline), EMBASE, Cochrane, CINAHL and PsycINFO 8 June 2017 and updated 14 January 2019, identified 2,104 abstracts. After screening of abstracts, 1607 articles were reviewed in full text and 33 articles included. These 33 articles reported OHIP-data for 9409 patients grouped in 63 patient populations. Median oro-facial appearance impact scores on a standardised 0-8 scale, for populations with treatment need relating to tooth wear, orthodontics, orthognathic surgery, frontal tooth loss and tooth whitening, ranged from 0.13 for tooth wear to 3.04 for tooth whitening populations. In conclusion, a moderate impact for the oro-facial appearance dimension of OHRQoL was found in patients with different conditions with esthetically related treatment need.
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Estética Dental , Calidad de Vida , Dolor Facial , Humanos , Salud Bucal , Encuestas y CuestionariosRESUMEN
Oral Function, Orofacial Pain, Orofacial Appearance, and Psychosocial Impact-the dimensions of oral health-related quality of life-capture dental patients' oral health problems worldwide and regardless of whether the patient currently suffers from oral diseases or intends to prevent them in the future. Using scores for these dimensions, the project Mapping Oral Disease Impact with a Common Metric (MOM) aims to provide four-dimensional oral health impact information across oral diseases and settings. In this article, project authors summarize MOM's findings and provide recommendations about how to improve standardized oral health impact assessment. Project MOM's systematic reviews identified four-dimensional impact information for 189 adult and 22 pediatric patient populations that were contained in 170 publications. A typical functional, pain-related, aesthetical, and psychosocial impact (on a 0-8 impact metric based on two items with a response format 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often) was about 2 to 3 units. Project MOM provides five recommendations to improve standardized oral health impact assessment for all oral diseases in all settings.
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Salud Bucal , Calidad de Vida , Adulto , Niño , Dolor Facial , Humanos , Encuestas y CuestionariosRESUMEN
OBJECTIVE: To evaluate whether retention is needed after orthodontic treatment of impacted maxillary canines. TRIAL DESIGN: Two-arm parallel group single-centre randomized controlled trial. MATERIALS AND METHODS: Sixty-three patients, 39 girls and 24 boys, were recruited to the study. The inclusion criteria were patients with at least one impacted or unerupted maxillary canine, and moderate irregularity of the maxillary six anterior teeth according to Little's index (LI). After gaining informed consent from the patient and their custodians, the patients were randomized to one of two groups, i.e. to a non-retention group or a retention group. The randomization process was prepared and carried out by an independent person not involved in the trial and the randomization used blocks of 20 (10 + 10). Primary outcomes were changes in single contact point discrepancy, and LI measured on digitalized three-dimensional study casts 1-year post-treatment. The study casts were anonymized before assessment and the changes were blinded for the assessor. Data were evaluated on an intention-to-treat basis. Thus, all randomized patients were incorporated into the final analysis. In the non-retention group a 10-week interim period was used to detect patients who eventually have a relapse immediately after treatment. If so, the patient got the arch-wire reinserted. Most patients in the retention group received a vacuum-formed retainer and pretreatment spacing cases got a bonded retainer. RESULTS: Mean irregularity change was 0.4 mm in the retention and 1.3 mm in the non-retention group (P < 0.001). Maximum change was 2.5 mm in the retention and 3.2 mm in the non-retention group (P < 0.001). Most changes in the non-retention group occurred during the 10-week interim period. In the non-retention group, one patient developed contact point discrepancy of >2 mm during the interim period and was realigned. HARMS: One patient met the stopping guideline criteria. This patient had the arch wire reinserted for 2 months. After realignment, the patient received a retention appliance. LIMITATIONS: The trial was a single-centre study and short-term changes were evaluated. CONCLUSIONS: Changes between the retention and the non-retention group were statistically but not clinically significant. Since satisfactory clinical results 1-year post-treatment were found in the non-retention group, retention does not appear to be needed. The 10-week interim period was useful in detecting patients who might have a relapse immediately after treatment. TRIAL REGISTRATION: The trial was not registered.
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Retenedores Ortodóncicos , Ortodoncia Correctiva , Adolescente , Diente Canino , Femenino , Humanos , Masculino , Diseño de Aparato Ortodóncico , Aparatos Ortodóncicos Fijos/efectos adversosRESUMEN
BACKGROUND: Retention of the maxillary anterior teeth is commonly recommended to maintain the teeth in their corrected positions. Both fixed and removable retention methods are used, but the certainty of evidence is low. OBJECTIVE: To evaluate post-treatment changes in irregularity of the maxillary six anterior teeth and single tooth contact point discrepancy (CPD) of three different retention methods. TRIAL DESIGN: Three-arm parallel group single-centre randomized controlled trial. MATERIALS AND METHODS: Ninety patients, 54 girls and 36 boys, were recruited to the study. The inclusion criteria were adolescent patients treated with fixed appliances at least in the maxilla. After gaining informed consent from the patient and their custodians, the patients were randomized to one of three groups: bonded retainer 13-23, bonded retainer 12-22, and removable vacuum-formed retainer (VFR) covering the maxillary teeth including the second molars. The randomization, prepared by an independent person, used blocks of 30. The primary outcomes were changes in single CPD and Little's irregularity index (LII) measured on digitalized three-dimensional study casts before and after 2-year retention. The study casts were anonymized before assessment and the changes were blinded for the assessor. Data were evaluated on an intention-to-treat basis. Thus, all randomized patients were incorporated into the final analysis. RESULTS: The LII and CPDs increased slightly in all three groups without any statistically significant differences between the groups. The VFR group showed a small intercanine width increase and some more changes of canine rotations than in the other groups. HARMS: No harm was observed in any subjects and none of the patients needed retreatment. LIMITATIONS: The trial was a single-centre study and short-term changes were evaluated. CONCLUSIONS: All three retention methods showed equally effective retention capacity and all the changes found in the three groups were small and considered clinically insignificant. Thus, the null hypothesis was confirmed. All three methods can be recommended. TRIAL REGISTRATION: NCT04616755.
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Retenedores Ortodóncicos , Ortodoncia Correctiva , Adolescente , Femenino , Humanos , Masculino , Diseño de Aparato Ortodóncico , Aparatos Ortodóncicos Fijos , VacioRESUMEN
OBJECTIVES: To compare early headgear activator treatment of Class II malocclusion with excessive overjet with untreated control subjects in terms of the primary outcomes overjet and overbite as well as the effect regarding oral-health-related quality of life (OHRQoL), lip closure, incidence of trauma, and skeletal changes. TRIAL DESIGN: Two-arm parallel group single-centre randomized controlled trial. MATERIAL AND METHODS: A total of 60 children (mean age 9.5 years) presenting a Class II malocclusion with excessive overjet were recruited. The trial was designed as intention-to-treat and the participants randomized by an independent person not involved in the trial to either early treatment with headgear activator or to an untreated control group (UG). Dental and skeletal variables as well as registrations of OHRQoL, lip closure, and incidence of trauma were recorded. For the treatment group, data were registered at baseline before treatment and when treatment was finished, corresponding to approximately 2 years. For the UG, registrations were made at baseline and at 11 years of age. Observers were blinded to treatment allocation when assessing outcomes. RESULTS: Early treatment with headgear activator significantly decreased overjet and improved molar relationship when compared with untreated controls. The effects were primarily due to dentoalveolar changes. Early treatment had no evident effect regarding OHRQoL, lip closure, or incidence of trauma. Lack of cooperation resulted in unsuccessful treatments for 27% of the patients. LIMITATIONS: The trial was a single-centre trial and can thus be less generalizable. CONCLUSIONS: The main treatment effect of early headgear activator treatment of Class II malocclusion with excessive overjet is reduction of overjet. TRIAL REGISTRATION: NCT04508322.
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Maloclusión Clase II de Angle , Sobremordida , Niño , Humanos , Maloclusión Clase II de Angle/terapia , Sobremordida/terapia , Calidad de VidaRESUMEN
Orthodontics has witnessed not only an exponential rise in demand from adult patients but accompanying this, the emergence of alternate aesthetic treatment options to the more traditional fixed labial appliance. The concept of using clear aligners as a means of achieving tooth movement has increased in popularity among both patients and clinicians alike. However, the question over best research evidence as to their clinical effectiveness to treat a range of malocclusion traits remains elusive and controversial among the profession.In an attempt to offer the profession some clear guidance, The Angle Society of Europe reviewed and discussed the current published evidence (2005-2018) on their clinical use, during the annual meeting in January 2020, to help formulate a consensus viewpoint on the clinical applications.
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Maloclusión , Aparatos Ortodóncicos Removibles , Adulto , Consenso , Europa (Continente) , Humanos , Maloclusión/terapia , Diseño de Aparato Ortodóncico , Técnicas de Movimiento DentalRESUMEN
OBJECTIVES: To evaluate the costs of quad-helix (QH) and removable expansion plate (EP) treatments performed either in specialist or general dentistry for the correction of unilateral posterior crossbite with functional shift in the mixed dentition. TRIAL DESIGN: Four-arm parallel group multicentre randomized controlled trial. MATERIALS AND METHODS: One hundred and ten patients with unilateral posterior crossbite with functional shift were recruited. The patients were randomized by an independent person not involved in the trial. The randomization used blocks of 20 and into the following four groups: QH treatments in specialist orthodontic clinics (QHS), QH treatments in general dentistry (QHG), EP treatments in specialist orthodontic clinics (EPS), and EP treatments in general dentistry (EPG). Blinding was accomplished of the outcome assessor and data analyst. A cost analysis was performed with reference to intention-to-treat (ITT), regarding direct costs, indirect costs, and societal costs (the sum of direct and indirect costs) for calculations of successful treatments alone and for retreatments when required. To determine which alternative has the lower cost, a cost-minimization analysis was undertaken, based on that the outcome of the treatment alternatives were broadly equivalent, so the difference between them reduces to a comparison of costs. RESULTS: In the QHS group, 28 of 28 patients were successfully corrected compared to 23 of 27 in the QHG group. Treatment with expansion plate was less successful: 18 of 27 patients in the EPS group and 18 of 28 in the EPG group. QH treatment performed in specialist orthodontic clinics had significantly lower costs than QH or EP treatment accomplished in general dentistry as well as EP treatments in specialist orthodontic clinics. LIMITATIONS: Costs depend on local factors and should not be directly extrapolated to other locations. CONCLUSION: Treatment of unilateral posterior crossbite in the mixed dentition is recommended to be performed by a specialist orthodontist using the QH appliance. TRIAL REGISTRATION: The trial was not registered.
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Maloclusión , Aparatos Ortodóncicos Removibles , Control de Costos , Costos y Análisis de Costo , Odontología , Dentición Mixta , Economía en Odontología , Humanos , Maloclusión/terapia , Aparatos Ortodóncicos Removibles/economía , Resultado del TratamientoRESUMEN
OBJECTIVES: The objectives of this study were to assess the three-dimensional (3D) treatment changes (palatal surface area and volume) of forced unilateral posterior crossbite correction using either quad-helix or removable expansion plate appliances in the mixed dentition, and to compare the treatment changes with the three-dimensional changes occurring in age-matched untreated unilateral posterior crossbite patients as well as in subjects with normal occlusion and with no or mild orthodontic treatment need. TRIAL DESIGN: Six-arm parallel group multicentre randomized controlled trial. MATERIALS AND METHODS: One-hundred and thirty-five patients with unilateral posterior crossbite with functional shift were recruited. The patients were randomized by an independent person not involved in the trial. The randomization used blocks of 25, and the patients were randomized into the following five groups: quad-helix treatments in specialist orthodontic clinics (QHS), quad-helix treatments in general dentistry (QHG), removable expansion plate treatments in specialist orthodontic clinics (EPS), removable expansion plate treatments in general dentistry (EPG), and untreated crossbite (UC). Twenty-five patients with normal occlusion who served as normal controls were also included in the trial. Blinding of the outcome assessor and data analyst was accomplished. Data on all children were evaluated on an intention-to-treat basis, regarding 3D palatal surface area, palatal projection area, and palatal shell volume; two-dimensional linear measurements were registered at the same time. RESULTS: After treatment, the surface and projection area and shell volume increased in the four treatment groups (QHS, QHG, EPS, and EPG). QHS increased significantly more than EPG for the surface and projection area. The QHS and EPS had significantly higher mean difference for shell volume. LIMITATIONS: The trial considers a short-term evaluation. CONCLUSION: After treatment, there were no significant differences between the four treatment groups and the normal group, which implies that the surface and projection area together with the shell volume for the four treatment groups and the normal group were equivalent. TRIAL REGISTRATION: The trial was registered with https://www.researchweb.org/is/sverige, registration number: 220751.
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Dentición Mixta , Maloclusión/terapia , Técnica de Expansión Palatina , Placas Óseas , Niño , Humanos , Hueso PaladarRESUMEN
Objective: To examine the validity and reliability of the Swedish versions of the short-form Child Perceptions Questionnaire 11-14 (CPQ11-14) and Parental Perceptions Questionnaire (P-CPQ) for measuring children's oral health-related quality of life (OHRQoL). Material and methods: The sample comprised 247 children and parents. OHRQoL was assessed by asking each child and their accompanying parent to complete the relevant questionnaire. To allow test-retest analysis, 30 children and 32 parents were asked to complete the instrument a second time within 2-4 weeks. Results: In terms of construct validity, significant correlations were observed between CPQ scale scores and the global ratings of oral health and overall well-being for both the CPQ11-14 and the P-CPQ. Regarding internal consistency, Cronbach's alphas for the total scales were 0.81 and 0.77, respectively, indicating good reliability, and internal consistency for the subscales (two or four dimensions) was acceptable. Test-retest reliability was good for the CPQ11-14 total scale (ICC 0.77) and acceptable for the P-CPQ total scale (ICC 0.63). Conclusions: The Swedish versions of the short-form CPQ11-14 and P-CPQ are both valid and reliable, and can be recommended for use among Swedish children aged 11-14 years for evaluation of OHRQoL.
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Salud Bucal , Padres , Psicometría/normas , Calidad de Vida , Adolescente , Adulto , Niño , Femenino , Humanos , Masculino , Padres/psicología , Percepción , Reproducibilidad de los Resultados , Encuestas y Cuestionarios/normas , SueciaRESUMEN
Objective: To explore the agreement between children and parents on children's oral health-related quality of life (OHRQoL) when using the Swedish short forms of CPQ11-14 and P-CPQ, and to evaluate the impact on agreement of oral health including malocclusion and background characteristics (dental fear, family situation, gender of informant). Material and methods: A total of 257 children and their accompanying parents were asked to fill in the Swedish versions of the short-form CPQ11-14 and P-CPQ separately in connection with a clinical examination. Results: The participants comprised 247 child-parent pairs: 116 (47%) boys, 131 (53%) girls, 166 (67%) mothers and 81 (33%) fathers. The agreement between the child and parental ratings of the children's OHRQoL was low, with an ICC of 0.22 (95% CI: 0.04-0.37) for the total scale. Conclusions: There was a low agreement between children's and parents' answers. For best care, it is advisable to consider perceptions of both children and parents because they can complement each other in estimating the child's OHRQoL.
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Salud Bucal , Padres/psicología , Calidad de Vida , Encuestas y Cuestionarios , Actitud Frente a la Salud , Niño , Atención Odontológica/estadística & datos numéricos , Femenino , Estado de Salud , Humanos , Masculino , SueciaRESUMEN
INTRODUCTION: The aim of this work was to analyze the dental and skeletal changes in patients treated with fixed orthodontic appliances with or without retention appliances, and to compare the changes with untreated subjects. Specifically, mandibular incisor irregularity was analyzed. METHODS: A total of 105 children who had undergone orthodontic treatment with fixed appliances in both jaws were examined in 2 groups: 64 had a lingual mandibular retainer and 41 had no retainer. Retention time was 2.7 ± 1.5 years. The untreated group consisted of 25 subjects. Measurements were done on study casts and lateral head radiographs before and after treatment and 6 and 12 years after treatment. The Little irregularity index (LII) was the most important variable. RESULTS: No differences were found in LII 12 years after treatment between the group that had a retainer and the group without a retainer after treatment. In the untreated group, LII was increased over time, but not to the same extent as in the treated groups. Correction of overjet and overbite was stable long-term. At the last examination, the amount of overjet was almost the same in all 3 groups. CONCLUSIONS: The routine use of mandibular retainers for 2 to 3 years does not appear to prevent long-term relapse. If the patient wants to constrain natural development and changes, lifelong retainers are needed.
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Incisivo , Maloclusión/terapia , Mandíbula , Retenedores Ortodóncicos , Ortodoncia Correctiva , Adolescente , Niño , Femenino , Humanos , Masculino , Factores de Tiempo , Adulto JovenRESUMEN
Objective: To analyse in 10 orthodontic journals how many randomized controlled trials (RCTs) performed 'single-', 'double-', 'triple-', or 'outcome assessors blinding' and to evaluate, from the number of RCTs that did not conduct blinding, how many could actually have achieved it. Material and methods: Randomized controlled trials published in 10 orthodontic journals between 1 September 2012 and 28 February 2018 were included. A search was performed in PubMed and conducted for publication type 'randomized controlled trial' for each journal. Two reviewers independently analysed each RCT and registered that blinding was performed and included which specific type. It was also evaluated whether misclassifications of blinding items occurred and whether it was possible to achieve blinding among the RCTs that did not perform blinding. Results: After applying the inclusion criteria, 203 RCTs were assessed, and 61.6 per cent of them had used blinding, with the main type being 'outcome assessors blinding' (40.4%) followed by 'single-blinding' (15.3%), 'double-blinding' (2.5%), and 'triple-blinding' (3.4%). In 38.4 per cent of the trials, no blinding was performed; however, 79.4 per cent of them could have achieved blinding. Fifteen RCTs (7.3%) misclassified the blinding in relation to single-, double-, or triple-blinding. Journals followed the CONSORT (AJODO, EJO, JO, OCR) published together significantly more RCTs that performed blinding than journals not following the CONSORT. Conclusions: Blinding of outcome assessors was the most frequent type, as orthodontic trials are often of intervention design and thereby difficult to mask for patients and trial staff. The misclassifications of blinding items may indicate suboptimal knowledge among researchers and peer-reviewers regarding the definitions for diverse blinding types.
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Método Doble Ciego , Ortodoncia/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Método Simple Ciego , Humanos , Ortodoncia/normas , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Proyectos de Investigación/normas , Proyectos de Investigación/estadística & datos numéricos , Informe de Investigación , Resultado del TratamientoRESUMEN
OBJECTIVE: To analyse cost-effectiveness of anchorage reinforcement with buccal miniscrews and with molar blocks. We hypothesized that anchorage with miniscrews is more cost-effective than anchorage with molar blocks. TRIAL DESIGN: A single-centre, two-arm parallel-group randomized controlled trial. METHODS: Adolescents (age 11-19 years) in need of treatment with fixed appliance, premolar extractions, and en masse retraction were recruited from one Public Dental Health specialist centre. The intervention arm received anchorage reinforcement with buccal miniscrews during space closure. The active comparator received anchorage reinforcement with molar blocks during levelling/alignment and space closure. The primary outcome measure was societal costs defined as the sum of direct and indirect costs. Randomization was conducted as simple randomization stratified on gender. The patients, caregivers, and outcome assessors were not blinded. RESULTS: Eighty patients were randomized into two groups. The trial is completed. All patients were included in the intention-to-treat analysis. The median societal costs for the miniscrew group were 4681 and for the molar block group were 3609. The median of the difference was 825 (95% confidence interval (CI) 431-1267). This difference was mainly caused by significantly higher direct costs consisting of material and chair time costs. Differences in chair time costs were related to longer treatment duration. No serious harms were detected, one screw fractured during insertion and three screws were lost during treatment. GENERALIZABILITY AND LIMITATIONS: The monetary variables are calculated based on a number of local factors and assumptions and cannot necessarily be transferred to other countries. Variables such as chair time, number of appointments, and treatment duration are generalizable. Owing to the study protocol, the benefit of miniscrews as a stable anchorage has not been fully utilized. CONCLUSIONS: When only moderate anchorage reinforcement is needed, miniscrews are less cost-effective than molar blocks. The initial hypothesis was rejected. Miniscrews provide better anchorage reinforcement at a higher price. They should be used in cases where anchorage loss cannot be accepted. TRIAL REGISTRATION: NCT02644811.
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Tornillos Óseos/economía , Métodos de Anclaje en Ortodoncia/economía , Métodos de Anclaje en Ortodoncia/instrumentación , Técnicas de Movimiento Dental/economía , Técnicas de Movimiento Dental/instrumentación , Adolescente , Citas y Horarios , Diente Premolar/cirugía , Tornillos Óseos/efectos adversos , Costo de Enfermedad , Análisis Costo-Beneficio , Femenino , Costos de la Atención en Salud/estadística & datos numéricos , Humanos , Masculino , Diente Molar , Suecia , Factores de Tiempo , Extracción Dental , Técnicas de Movimiento Dental/efectos adversos , Técnicas de Movimiento Dental/métodos , Adulto JovenRESUMEN
OBJECTIVES: To compare Oral health-related quality of life (OHRQoL) among 9-year-old children with excessive overjet (EO) to children with unilateral posterior crossbite (UPC) and children with normal occlusion (NO). MATERIALS AND METHODS: The study sample sourced from 19 Public Dental Service Clinics in Sweden. Reported are baseline data originating from two controlled trials, one regarding UPC and the other focusing on EO. The NO children derive from the same trials. The UPC group comprised 93 children (45 boys and 48 girls), the EO group 71 children (36 boys and 35 girls), and the NO group 65 children (32 boys and 33 girls). In conjunction to a clinical examination, all children completed the Child Perceptions Questionnaire (CPQ8-10) for evaluation of OHRQoL. The CPQ8-10 comprises 25 questions grouped into four domains: oral symptoms, functional limitations, emotional, and social well-being. Validated questions about pain in the jaws and face were also included. RESULTS: The total mean CPQ score was 5.1 for the UPC, 7.4 for the EO, and 4.4 for the NO group, showing a significant difference between the UPC and EO (P = 0.048) and between EO and NO group (P = 0.012). These differences remained when adjusted for the confounders' caries, trauma, enamel defects, and headache. No difference between UPC and NO was found. The EO children also reported significantly higher scores in the domains emotional and social well-being (P = 0.039 and P = 0.012). LIMITATIONS: The study would be strengthened if a longitudinal design had been performed. CONCLUSION: Children with EO reported significantly lower OHRQoL compared to children with UPC or NO. The children generally reported low CPQ scores that imply an overall fairly good OHRQoL.
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Maloclusión/psicología , Salud Bucal , Calidad de Vida , Adolescente , Estudios de Casos y Controles , Niño , Atención Odontológica , Caries Dental/psicología , Emociones , Femenino , Humanos , Masculino , Ortodoncia Correctiva , Sobremordida/psicología , Psicometría , Encuestas y Cuestionarios , SueciaRESUMEN
One goal of producing relevant clinical research is to ensure that evidence-based research results are transformed into everyday clinical practice that help clinicians deliver high quality care. It also involves ensuring that the individual patient receives the most effective and least risky treatment, ultimately leading to an optimal treatment outcome both in the short and long term. Some fundamentals of evidence-based dentistry are highlighted with focus on performing orthodontic randomised controlled trials.
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Odontología Basada en la Evidencia , Ortodoncia , Ensayos Clínicos Controlados Aleatorios como Asunto , HumanosRESUMEN
OBJECTIVES: The objective of this study was to investigate the number and proportions, study design, journal publications, authors and countries involved in orthodontic randomised controlled trials (RCTs) over the past 50 years. METHOD: A MEDLINE database search (Entrez PubMed, http://www.ncbi.nlm.nih.gov ) was performed in November 2018 for RCT publications from 1 January 1968 to 31 December 2017. All orthodontic publications, clinical trials (CTs) or RCTs were selected. For each year from 1968 to 2017, the total number of orthodontic publications and total number of CTs and RCTs were computed. Following this, study design, journal publications, authors and countries involved in orthodontic RCTs were noted. RESULTS: The RCTs accounted for 0.1% of all orthodontic publications in the 1970s and 1980s, and, following this, the proportion of RCTs was increased and amounted to 2.7% over the past decade (2008-2017). The majority of RCTs were of single centre design (93.4%) and in 88.3% a parallel-arm design was performed. The United States and United Kingdom endorsed 16.9% and 15.5% of the RCTs, followed by Turkey (11.1%), Brazil (7.0%), Sweden (6.6%), China (5.6%), Italy (5.4%), and Germany (4.1%). Of all RCTs, 74.2% were published in 20 orthodontic journals and 25.8% in 81 non-orthodontic journals. The American Journal of Orthodontics and Dentofacial Orthopedics, Angle Orthodontist, European Journal of Orthodontics and Journal of Orthodontics contributed to 60.2% of all the RCTs. CONCLUSION: The considerable increase in orthodontic RCTs over the past 50 years implies an increased scientific impact of orthodontic literature.
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Ortodoncia , Publicaciones Periódicas como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Bibliometría , China , MEDLINE , Encuestas y Cuestionarios , Reino Unido , Estados UnidosRESUMEN
INTRODUCTION: Anchorage can be reinforced in many ways. Due to the variety of anchorage concepts, only a few general conclusions can be drawn. Therefore, more research is needed to investigate specific concepts with specific indications. The objective of this trial was to compare the anchorage capacities of miniscrews and molar blocks. METHODS: This randomized controlled trial was conducted on 2 parallel arms. The trial was conducted at the Public Dental Service Orthodontic Clinic in Gävle, Sweden. Participants were adolescents who needed orthodontic treatment with a fixed appliance, extraction of the maxillary first premolars, and anchorage reinforcement. In group A, miniscrews were used as direct anchorage during space closure. In group B, molar blocks were used as anchorage reinforcement during leveling and alignment and space closure. The primary outcome was loss of anchorage assessed as maxillary first molar movement. Random allocation was maintained with a simple randomization stratified by sex. The observer was blinded to the allocations during the measurements. RESULTS: Forty participants each were randomized to groups A and B. Results were analyzed on an intention-to-treat basis, meaning that all participants, successful or not, were included in the analysis. Group A showed a mean anchorage loss of 1.2 mm during leveling and alignment. During space closure with miniscrews, no significant anchorage loss was found. Group B showed mean anchorage losses of 1.4 mm during leveling and alignment and 2.4 mm during space closure. No serious harms were detected. The first molar rotation, torque, and tipping showed different characteristics during the treatment phases. CONCLUSIONS: Miniscrews can be recommended for anchorage reinforcement. Depending on the need for anchorage reinforcement, miniscrews can be inserted at the beginning of treatment or when space closure starts. Molar blocks cannot be recommended for anchorage reinforcement. REGISTRATION: This trial was registered at www.clinicaltrials.gov (NCT02644811). PROTOCOL: The protocol was published after trial commencement. FUNDING: This trial received funding from the Center for Research and Development, Uppsala University/Region Gävleborg; Thuréus Foundation for the Promotion of Dental Science; and the Swedish Dental Associations Scientific Funds.