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Comparisons of costs and treatment effects—an RCT on headgear activator treatment of excessive overjet in the mixed and late mixed dentition

Kallunki, Jenny (author)
Region Östergötland, Centrum för Ortodonti/Pedodonti Norrköping,The Center for Orthodontics and Pedodontics, County Council Östergötland, Norrköping, Sweden
Bondemark, Lars (author)
Malmö universitet,Odontologiska fakulteten (OD),Department of Orthodontics, Faculty of Odontology, Malmö University, Malmö, Sweden
Paulsson, Liselotte (author)
Malmö universitet,Odontologiska fakulteten (OD),Department of Orthodontics, Faculty of Odontology, Malmö University, Malmö, Sweden
 (creator_code:org_t)
2021-05-27
2022
English.
In: European Journal of Orthodontics. - Oxford, United Kingdom : Oxford University Press. - 0141-5387 .- 1460-2210. ; 44:1, s. 86-94
  • Journal article (peer-reviewed)
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  • 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.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Odontologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Dentistry (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Hälsovetenskap -- Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Health Sciences -- Health Care Service and Management, Health Policy and Services and Health Economy (hsv//eng)

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Kallunki, Jenny
Bondemark, Lars
Paulsson, Liselo ...
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MEDICAL AND HEALTH SCIENCES
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and Dentistry
MEDICAL AND HEALTH SCIENCES
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Linköping University
Malmö University

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