{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T23:50:40Z","timestamp":1780962640053,"version":"3.54.1"},"reference-count":33,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2020,12,4]],"date-time":"2020-12-04T00:00:00Z","timestamp":1607040000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"Eklund foundation Malm\u00f6, Sweden"},{"DOI":"10.13039\/501100009457","name":"Region \u00d6sterg\u00f6tland","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100009457","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Sweden and Faculty of Odontology"},{"name":"Malm\u00f6 University, Sweden"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,12,1]]},"abstract":"<jats:title>Summary<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial design<\/jats:title>\n                  <jats:p>Two-arm parallel group single-centre randomized controlled trial.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Material and methods<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Limitations<\/jats:title>\n                  <jats:p>The trial was a single-centre trial and can thus be less generalizable.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The main treatment effect of early headgear activator treatment of Class II malocclusion with excessive overjet is reduction of overjet.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration<\/jats:title>\n                  <jats:p>NCT04508322.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ejo\/cjaa073","type":"journal-article","created":{"date-parts":[[2020,10,25]],"date-time":"2020-10-25T20:07:45Z","timestamp":1603656465000},"page":"639-647","source":"Crossref","is-referenced-by-count":11,"title":["Early headgear activator treatment of Class II malocclusion with excessive overjet: a randomized controlled trial"],"prefix":"10.1093","volume":"43","author":[{"given":"Jenny","family":"Kallunki","sequence":"first","affiliation":[{"name":"The Center for Orthodontics and Pedodontics, County Council \u00d6sterg\u00f6tland, Norrk\u00f6ping, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars","family":"Bondemark","sequence":"additional","affiliation":[{"name":"Department of Orthodontics, Faculty of Odontology, Malm\u00f6 University, Malm\u00f6, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liselotte","family":"Paulsson","sequence":"additional","affiliation":[{"name":"Department of Orthodontics, Faculty of Odontology, Malm\u00f6 University, Malm\u00f6, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,12,4]]},"reference":[{"key":"2021120504331396200_CIT0001","doi-asserted-by":"crossref","first-page":"728","DOI":"10.2319\/080414-542.1","article-title":"Prevalence and change of malocclusions from primary to early permanent dentition: a longitudinal study","volume":"85","author":"Dimberg","year":"2015","journal-title":"The Angle Orthodontist,"},{"key":"2021120504331396200_CIT0002","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1111\/edt.12126","article-title":"Over two hundred million injuries to anterior teeth attributable to large overjet: a meta-analysis","volume":"31","author":"Petti","year":"2015","journal-title":"Dental Traumatology,"},{"key":"2021120504331396200_CIT0003","first-page":"15","article-title":"Incidence of traumatic tooth injuries in children and adolescents in the county of V\u00e4stmanland, Sweden","volume":"20","author":"Glendor","year":"1996","journal-title":"Swedish Dental Journal,"},{"key":"2021120504331396200_CIT0004","doi-asserted-by":"crossref","DOI":"10.1002\/14651858.CD003452.pub4","article-title":"Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents","author":"Batista","year":"2018","journal-title":"Cochrane Database of Systematic Reviews"},{"key":"2021120504331396200_CIT0005","doi-asserted-by":"crossref","first-page":"580","DOI":"10.1016\/j.ajodo.2008.02.020","article-title":"Early treatment for Class II malocclusion and perceived improvements in facial profile","volume":"135","author":"O\u2019Brien","year":"2009","journal-title":"American Journal of Orthodontics and Dentofacial Orthopedics,"},{"key":"2021120504331396200_CIT0006","doi-asserted-by":"crossref","first-page":"238","DOI":"10.1093\/ejo\/cju046","article-title":"The impact of malocclusion on the quality of life among children and adolescents: a systematic review of quantitative studies","volume":"37","author":"Dimberg","year":"2015","journal-title":"European Journal of Orthodontics,"},{"key":"2021120504331396200_CIT0007","doi-asserted-by":"crossref","first-page":"111","DOI":"10.1093\/ejo\/cjy033","article-title":"Oral health-related quality of life among children with excessive overjet or unilateral posterior crossbite with functional shift compared to children with no or mild orthodontic treatment need","volume":"41","author":"Kallunki","year":"2019","journal-title":"European Journal of Orthodontics,"},{"key":"2021120504331396200_CIT0008","doi-asserted-by":"crossref","first-page":"488","DOI":"10.1016\/j.ajodo.2003.06.001","article-title":"Effectiveness of early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 2: Psychosocial effects","volume":"124","author":"O\u00b4Brien","year":"2003","journal-title":"American Journal of Orthodontics and Dentofacial Orthopedics,"},{"key":"2021120504331396200_CIT0009","first-page":"12","article-title":"The prevalence of malocclusion in Swedish schoolchildren","volume":"81","author":"Thilander","year":"1973","journal-title":"Scandinavian Journal of Dental Research,"},{"key":"2021120504331396200_CIT0010","doi-asserted-by":"crossref","first-page":"273","DOI":"10.1093\/ejo\/25.3.273","article-title":"Orofacial analysis on the Adriatic islands: an epidemiological study of malocclusions on Hvar Island","volume":"25","author":"Lauc","year":"2003","journal-title":"European Journal of Orthodontics,"},{"key":"2021120504331396200_CIT0011","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1093\/ejo\/cjl054","article-title":"Malocclusion frequency in Swedish and immigrant adolescents\u2013influence of origin on orthodontic treatment need","volume":"29","author":"Josefsson","year":"2007","journal-title":"European Journal of Orthodontics,"},{"key":"2021120504331396200_CIT0012","doi-asserted-by":"crossref","first-page":"353","DOI":"10.1016\/0002-9416(72)90300-4","article-title":"Simultaneous use of cervical appliance and activator: an orthopedic approach to fixed appliance therapy","volume":"61","author":"Pfeiffer","year":"1972","journal-title":"American Journal of Orthodontics,"},{"key":"2021120504331396200_CIT0013","first-page":"594","article-title":"Stability of Class II, division 1 treatment with the headgear-activator combination followed by the edgewise appliance","volume":"74","author":"Janson","year":"2004","journal-title":"The Angle Orthodontist,"},{"key":"2021120504331396200_CIT0014","doi-asserted-by":"crossref","first-page":"258","DOI":"10.1016\/0002-9416(78)90202-6","article-title":"A growth-related concept for skeletal class II treatment","volume":"74","author":"Teuscher","year":"1978","journal-title":"American Journal of Orthodontics,"},{"key":"2021120504331396200_CIT0015","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1093\/ejo\/cji062","article-title":"Effects of activator and activator headgear treatment: comparison with untreated Class II subjects","volume":"28","author":"T\u00fcrkkahraman","year":"2006","journal-title":"European Journal of Orthodontics,"},{"key":"2021120504331396200_CIT0016","doi-asserted-by":"crossref","first-page":"149","DOI":"10.1093\/ejo\/16.2.149","article-title":"Class II: a comparison of activator and activator headgear combination appliances","volume":"16","author":"Ozt\u00fcrk","year":"1994","journal-title":"European Journal of Orthodontics,"},{"key":"2021120504331396200_CIT0017","first-page":"512","article-title":"Questionnaire for measuring oral health-related quality of life in eight- to ten-year-old children","volume":"26","author":"Jokovic","year":"2004","journal-title":"Pediatric Dentistry,"},{"key":"2021120504331396200_CIT0018","doi-asserted-by":"crossref","first-page":"459","DOI":"10.1177\/154405910208100705","article-title":"Validity and reliability of a questionnaire for measuring child oral-health-related quality of life","volume":"81","author":"Jokovic","year":"2002","journal-title":"Journal of Dental Research,"},{"key":"2021120504331396200_CIT0019","doi-asserted-by":"crossref","first-page":"27","DOI":"10.3109\/00016356408993963","article-title":"A Method for epidemiological registration of malocclusion","volume":"22","author":"Bjoerk","year":"1964","journal-title":"Acta Odontologica Scandinavica,"},{"key":"2021120504331396200_CIT0020","first-page":"314","article-title":"International Association of Dental Traumatology guidelines for the management of traumatic dental injuries: 1. Fractures and luxations","volume-title":"Dental Traumatology","author":"Bourguignon","year":"2020"},{"key":"2021120504331396200_CIT0021","first-page":"104","article-title":"The relationship of the jaws to the cranium.","volume-title":"Introduction to Orthodontics","author":"Bj\u00f6rk","year":"1960"},{"key":"2021120504331396200_CIT0022","doi-asserted-by":"crossref","first-page":"370","DOI":"10.1093\/ejo\/cji033","article-title":"Roentgen-cephalometric standards for a Swedish population. A longitudinal study between the ages of 5 and 31 years","volume":"27","author":"Thilander","year":"2005","journal-title":"European Journal of Orthodontics,"},{"key":"2021120504331396200_CIT0023","first-page":"122","volume-title":"Statistical Methods for Medical and Biological Students","author":"Dahlberg","year":"1940"},{"key":"2021120504331396200_CIT0024","doi-asserted-by":"crossref","first-page":"234","DOI":"10.1016\/S0889-5406(03)00352-4","article-title":"Effectiveness of early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 1: Dental and skeletal effects","volume":"124","author":"O\u2019Brien","year":"2003","journal-title":"American Journal of Orthodontics and Dentofacial Orthopedics,"},{"key":"2021120504331396200_CIT0025","doi-asserted-by":"crossref","first-page":"391","DOI":"10.1016\/S0889-5406(97)80021-2","article-title":"The effect of early intervention on skeletal pattern in Class II malocclusion: a randomized clinical trial","volume":"111","author":"Tulloch","year":"1997","journal-title":"American Journal of Orthodontics and Dentofacial Orthopedics,"},{"key":"2021120504331396200_CIT0026","doi-asserted-by":"crossref","first-page":"279","DOI":"10.1016\/j.ajodo.2014.05.022","article-title":"Do orthodontic research outcomes reflect patient values? A systematic review of randomized controlled trials involving children","volume":"146","author":"Tsichlaki","year":"2014","journal-title":"American Journal of Orthodontics and Dentofacial Orthopedics,"},{"key":"2021120504331396200_CIT0027","first-page":"194","article-title":"Dental caries are more likely to impact on children\u2019s quality of life than malocclusion or traumatic dental injuries","volume":"19","author":"Martins","year":"2018","journal-title":"European Journal of Paediatric Dentistry,"},{"key":"2021120504331396200_CIT0028","doi-asserted-by":"crossref","first-page":"e0185365","DOI":"10.1371\/journal.pone.0185365","article-title":"Dental caries remains as the main oral condition with the greatest impact on children\u2019s quality of life","volume":"12","author":"Martins","year":"2017","journal-title":"PLoS One,"},{"key":"2021120504331396200_CIT0029","doi-asserted-by":"crossref","first-page":"71","DOI":"10.1111\/edt.12389","article-title":"World traumatic dental injury prevalence and incidence, a meta-analysis-One billion living people have had traumatic dental injuries","volume":"34","author":"Petti","year":"2018","journal-title":"Dental Traumatology,"},{"key":"2021120504331396200_CIT0030","doi-asserted-by":"crossref","first-page":"516","DOI":"10.1093\/ejo\/cjv080","article-title":"Treatment of large overjet in Angle Class II: division 1 malocclusion with Andresen activators versus prefabricated functional appliances-a multicenter, randomized, controlled trial","volume":"38","author":"\u010cirgi\u0107","year":"2016","journal-title":"European Journal of Orthodontics,"},{"key":"2021120504331396200_CIT0031","doi-asserted-by":"crossref","first-page":"e155","DOI":"10.1016\/j.ajodo.2011.02.023","article-title":"Effect of early Class II treatment on the incidence of incisor trauma","volume":"140","author":"Chen","year":"2011","journal-title":"American Journal of Orthodontics and Dentofacial Orthopedics,"},{"key":"2021120504331396200_CIT0032","doi-asserted-by":"crossref","first-page":"457","DOI":"10.1093\/ejo\/cjv046","article-title":"Randomized controlled trial: the gold standard or an unobtainable fallacy?","volume":"37","author":"Bondemark","year":"2015","journal-title":"European Journal of Orthodontics,"},{"key":"2021120504331396200_CIT0033","doi-asserted-by":"crossref","first-page":"267","DOI":"10.1016\/j.jclinepi.2013.08.015","article-title":"Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects","volume":"67","author":"McCambridge","year":"2014","journal-title":"Journal of Clinical Epidemiology,"}],"container-title":["European Journal of Orthodontics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ejo\/article-pdf\/43\/6\/639\/41428622\/cjaa073.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ejo\/article-pdf\/43\/6\/639\/41428622\/cjaa073.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,12,5]],"date-time":"2021-12-05T04:33:45Z","timestamp":1638678825000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ejo\/article\/43\/6\/639\/6020063"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,12,4]]},"references-count":33,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2020,12,4]]},"published-print":{"date-parts":[[2021,12,1]]}},"URL":"https:\/\/doi.org\/10.1093\/ejo\/cjaa073","relation":{},"ISSN":["0141-5387","1460-2210"],"issn-type":[{"value":"0141-5387","type":"print"},{"value":"1460-2210","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2021,12,1]]},"published":{"date-parts":[[2020,12,4]]}}}