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24 Orthodontics KCE Reports 77 This system assessing the quality of the evidence was not applied to individual studies, but to the body of evidence relating to a specific pathology or research question. In this report, the production of grades of recommendations was considered to be beyond the scope of the study. Table 2: Levels of evidence and grade recommendations (Source: Guyatt et al. (2006) 3 ) Grade of Recommendation/ Description 1A/Strong recommendation, highquality evidence 1B/Strong recommendation, moderate quality evidence 1C/Strong recommendation, low-quality or very low-quality evidence 2A/Weak recommendation, highquality evidence 2B/Weak recommendation, moderate-quality evidence 2C/Weak recommendation, low quality or very lowquality evidence Benefit vs Risk and Burdens Benefits clearly outweigh risk and burdens, or vice versa Benefits clearly outweigh risk and burdens, or vice versa Benefits clearly outweigh risk and burdens, or vice versa Benefits closely balanced with risks and burden Benefits closely balanced with risks and burden Uncertainty in the estimates of benefits, risks, and burden; benefits, risk, and burden may be closely balanced Methodological Quality of Supporting Evidence RCTs without important limitations or overwhelming evidence from observational studies RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies Observational studies or case series RCTs without important limitations or overwhelming evidence from observational studies RCTs with important limitations (inconsistent results, methodological flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies Observational studies or case series Implications Strong recommendation, can apply to most patients in most circumstances without reservation Strong recommendation, can apply to most patients in most circumstances without reservation Strong recommendation but may change when higher quality evidence becomes available Weak recommendation, best action may differ depending on circumstances or patients' or societal values 2.2.3 Data extraction, tables of evidence and level of evidence Weak recommendation, best action may differ depending on circumstances or patients’ or societal values Very weak recommendations: other alternatives may be equally reasonable First the studies retrieved for more detailed evaluation were assessed according to the Cochrane checklists, where possible. An excel file was completed for every article and again where possible the level of evidence was added. One example of the exhaustive procedure is added in the Appendix of Chapter 2.
KCE Reports 77 Orthodontics 25 2.3 RESULTS OF THE CLINICAL PART OF THE LITERATURE STUDY 2.3.1 Indications and contra-indications of orthodontic treatment When orthodontic provision is seen as a part of the health service, it is important to critically analyse the benefits of changing malocclusions towards the norm of “ideal” occlusion. If, for instance, untreated malocclusions lead to adverse effects or induce medical complications, it is obvious that orthodontic treatment should aim at preventing these complications. In the literature several indications are given to start an orthodontic treatment. The question is, which of these indications are based on pure medical-biological reasons (e.g. cleft palate, prevention of trauma,…), and which of them are based on other reasons, like psychosocial wellbeing. According to the Constitution of the WHO published in 1946 l , 'health' should be defined as "A state of complete physical, mental and social well-being and not merely the absence of disease or infirmity". So, from a bio-psycho-social point of view, psycho-social aspects also contribute to health, but it is up to society to judge to which extent such indications for treatment should be financed by the government; more specifically by the national health care insurance. Nowadays, an indication for an orthodontic treatment is often based on purely morphological considerations. The treatment priority indices, that are used today, are mainly based on morphological descriptions. However, as will be shown below, more evidence on the severity of malocclusion and the consequences of not treating malocclusions is still needed 4 . Consequences of malocclusion with regard to psychosocial, physical or functional wellbeing have seldom been seriously taken into consideration. Recent years have seen the transcendence of a psycho-social justification for orthodontic treatment -the enhancement of psycho-social well-being through improvements in appearance, thus 'self-concept' m -, and research has suggested that orthodontic treatment may have significant benefits in improving the 'Oral Health Impact' on life-quality. Orthodontic treatment ought to be motivated by the benefits the treatment is supposed to produce for the patient 4 , the morphological alteration being merely the tool to reach the goal. The supposed benefits yielded by orthodontic treatment should always be weighted against the risk of iatrogenic damage, inconvenience to the patient,… 2.3.1.1 Adverse effects of untreated malocclusions CLEFT LIP AND PALATE Orofacial clefts have a severe impact on facial aesthetics, on orofacial function and on 5, 6 psycho-social development and well being of the affected individual Effects of the cleft on the facial appearance and dentition become apparent in different stages of life: the primary effects are apparent immediately after birth, secondary effects in the teenage years, and tertiary effects, after the completion of growth, in adulthood. According to consensus clinical expert opinion (and as it is ethically not justifiable to not treat these patients), orthodontic treatment is an important aspect of the multidisciplinary treatment planning of cleft lip and/of palate patients 7 and has a high impact not only on their malocclusion, but also on Oral Health Quality of Life parameters 8 . l World Health Organization. Constitution. Geneva: WHO, 1946 m Shaw W.C and Turbill E.A. (2007). Public Health Aspects of Oral Diseases and Disorders - Dentofacial Irregularities. pp 227- 237; Chapter 9f in Community Oral Health, Ed: Cynthia Pine and Rebecca Harris, Quintessence Books, Quintessence Publishing Co, Ltd, London, Berlin, Chicago et al.
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