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Wearing a brace places a considerable burden on young people and their parents. In addition to problems with pain and discomfort from braces and coping with the appearance, wearing an active brace requires regular visits to the orthodontist, involving time off school or work for the parent and travelling to and from the surgery. The young person also has to look after the brace, so that it does not break and keep it clean, so that it does not damage the teeth.
It is not surprising then that a proportion of young people do not wear their brace as prescribed or ask to have their braces removed before the orthodontist considers the treatment has finished. Incomplete treatment can lead to unsightly gaps, if teeth have been taken out, as well as unstable positions of the teeth and relapse back to their original position. One randomised controlled trial investigating the treatment of young people with quite a severe malocclusion, in 14 UK hospital orthodontic departments found that 12 % (19 out of 159) dropped out or did not return for comprehensive orthodontic treatment.(O'Brien et al., 2009) This figure rose to a surprising 37% (41 out of 110) who did not complete treatment using a particular type of removable brace (O'Brien et al., 2003).
Incomplete treatment represents a huge waste of time and money to the young people and their parents, who have sought out and started orthodontic treatment, as well as to the clinicians who are treating them and the NHS, which is funding the treatment. This wasted spending could be between £32 to £101 million per annum, based on the current expenditure and depending upon the true dropout rate. Investigating the impact of orthodontic appliances on young people might give insight into why some cannot tolerate appliances and give up part way through treatment. A validated measure of appliance impact would be a very relevant outcome measure in clinical trials investigating differences between orthodontic appliances. There is currently a paucity of clinical trials in the orthodontic literature that have used properly validated patient reported outcomes (Tsichlaki and O'Brien, 2014).
A previous attempt to assess the impact of fixed appliances has been undertaken by Mandall and colleagues (Mandall et al., 2006). They carried out a mixed methods study to produce a questionnaire investigating the impact of fixed appliances on young people aged 10 to 18 years. The questionnaire has been little used as an outcome measure and it would be interesting to see if the issues with fixed appliances are common to other types of appliances, particularly those that the patient can remove, which might affect how well they are worn. It would also be interesting to see how the impact of active appliances differs from those worn for retention. The aim of this study is therefore to build on the work of Mandall and colleagues and produce a questionnaire that can be used for any type of orthodontic appliance.
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| Study Design
The project will follow a well-developed mixed methods methodology developed by Guyatt and colleagues (Guyatt et al., 1986), which has been used successfully by researchers at the University of Sheffield School of Clinical Dentistry, to develop and initially validate several questionnaires measuring the impact of three dental conditions (Boiko et al., 2010, Gilchrist et al., 2015, Benson et al., 2016, Patel et al., 2016). The study will involve two stages:
1. Developing the measure;
2. Testing the measure.
STAGE 1 includes a qualitative study of young people’s experiences of orthodontic appliances through conducting and analysing individual interviews.
STAGE 2 involves validating the measure in two phases. The first phase includes a qualitative study, involving panel interviews or one-to-one interviews to test face and content validity. This will ensure that participants understand the items, instructions and response format of the questionnaire and that no important items have been omitted. The second phase of validation will involve a cross-sectional quantitative study (survey) using the developed instrument. Further longitudinal testing to assess responsiveness will be required in a follow-up study
Justification
A validated questionnaire assessing the impact of orthodontic appliances on young people’s everyday life will be a very helpful patient reported outcome measure for use in clinical trials of orthodontic interventions. It might also aid a reduction in the proportion of patients who fail to complete orthodontic treatment. By measuring the impact of orthodontic appliances this will assist clinicians understanding of their patients’ experiences and help to identify and provide support to those who are struggling to cope with their appliance. This will help reduce the considerable waste of time and money that patients, parents, clinicians and the NHS sustains when braces are removed early or not worn as advised.
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Benson PE, Cunningham SJ, Shah N, Gilchrist F, Baker SR, Hodges SJ, et al. Development of the Malocclusion Impact Questionnaire (MIQ) to measure the oral health-related quality of life of young people with malocclusion: part 2 - cross-sectional validation. J Orthod 2016; 43: 14-23.
Boiko OV, Baker SR, Gibson BJ, Locker D, Sufi F, Barlow AP, et al. Construction and validation of the quality of life measure for dentine hypersensitivity (DHEQ). J Clin Periodontol 2010; 37: 973-980.
Gilchrist F, Marshman Z, Deery C, Rodd HD. The impact of dental caries on children and young people: what they have to say? Int J Paediatr Dent 2015; 25: 327-338.
Guyatt GH, Bombardier C, Tugwell PX. Measuring disease-specific quality of life in clinical trials. Can Med Assoc J 1986; 134: 889-895.
Mandall NA, Vine S, Hulland R, Worthington HV. The impact of fixed orthodontic appliances on daily life. Community Dent Health 2006; 23: 69-74.
O'Brien K, Wright J, Conboy F, Appelbe P, Davies L, Connolly I, et al. Early treatment for Class II Division 1 malocclusion with the Twin-block appliance: a multi-center, randomized, controlled trial. Am J Orthod Dentofacial Orthop 2009; 135: 573-579.
O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, et al. Effectiveness of treatment for Class II malocclusion with the Herbst or twin-block appliances: a randomized, controlled trial. Am J Orthod Dentofacial Orthop 2003; 124: 128-137.
Patel N, Hodges SJ, Hall M, Benson PE, Marshman Z, Cunningham SJ. Development of the Malocclusion Impact Questionnaire (MIQ) to measure the oral health-related quality of life of young people with malocclusion: part 1 - qualitative inquiry. J Orthod 2016; 43: 7-13.
Tsichlaki A, O'Brien K. Do orthodontic research outcomes reflect patient values? A systematic review of randomized controlled trials involving children. Am J Orthod Dentofacial Orthop 2014; 146: 279-285.
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