The Effect of Timing on Lateral Crossbite Correction - a Randomized Study

1. The aim of this longitudinal randomized investigation is to determine the long-term effects of early lateral crossbite correction with Quad-Helix appliance, during the deciduous dentition, on craniofacial structures and dental arches, compared to treatment started later, after the first permanent molars have erupted.
2. The aim was further to find out the possible benefits and the burden of early treatment to the patients and parents of these common malocclusions, when compared to groups treated later, but with the same methods as much as possible.
3. The hypothesis is that the timing of treatment has significant effects on orthodontic treatment total time, the general outcome of the treatment, and the compliance of the patient.
4. Background. In spite of the fact that about 30 to 50% of the children in Europe undergo orthodontic treatment during growth, negligible amount of RCT based data is available concerning these treatments.
5. The most used treatment method in Finland, and one of the most popular in the world, is to treat lateral malocclusion with the maxillary dental arch expanding Quad-Helix appliance (Bodoy et al., 2011; Petren et al., 2011; Lippold et al., 2013).

The goal of the expansion treatment is typically described as to expand maxillary dental arch, expand the maxilla and correct the possible functional shift in the occlusion.

The views of the effects of the expanding devices during early childhood are to some extent inconclusive, at least when the long-term effects are concerned. Most reports that are based on a short-term follow-up, describing maxillary arch expansion and the correction of the crossbite. When the Quad-Helix appliance is compared to the removable appliance, the Q-H is found to be more effective (Petren et al., 2011). When it comes to the elimination of the functional lateral shift after the crossbite treatment, the research data is weak and not sufficient (Tsanidis et al., 2016). Valid evidence based data is rare and the thus exact conclusions are very difficult to be set. 6. Preliminary Studies. The investigators conducted a randomized clinical study with an expanding Headgear device, where the control group was treated with a camouflage treatment, without expansion in the adolescence. The main difference between the groups was broader dental arch with less extractions in the headgear group, the differences between the groups being relatively small, except the broader dental arch in the Headgear group. (Mäntysaari et al.,2004; Pirttiniemi et al.,2005; Krusinskiene et al., 2008). However, canine eruption pattern was found to be more favorable in the early headgear group (Silvola et al., 2008). 7. Experimental Design and Methods

• The Age cohort of five-year-old of children living in the community areas of Oulunsalo are screened at the age of 5 years for malocclusions. Of these children 80 children who meet the criteria are chosen for the study after the written consent. The inclusion criteria are crossbite of at least two deciduous lateral teeth.
• Exclusion criteria are anterior crossbite, missing permanent teeth, or craniofacial anomaly.
• The subjects are randomized into two groups. In the first group the treatment with Quad-Helix appliance is started at the age of 5 to 6 years, before the eruption of the permanent molars. The device is cemented to the second deciduous molars. The treatment is continued and continued until normal lateral occlusion is achieved and the device is kept stable for one year after this.
• In the second group headgear treatment is started after the first permanent maxillary molars have erupted. The device is cemented to the first permanent molars. The treatment is continued until normal lateral occlusion is achieved and the device is kept stable for one year after this In both groups dental casts, cephalograms, and standardized 3D facial photographs are taken before treatment (T0), after the first treatment phase (T1), after the second treatment phase (T2) and after the growth (T3).

Facial 3D scanning is performed for all the subjects after the treatment to find out the effect of different treatment methods on facial characteristics. The dental casts are scanned to make 3D models of the cast to be used in detailed analysis.

• A wide multi-level questionnaire is performed before, during and after the study to the parents and the children to find out the comprehensive effects of orthodontic treatment on the well-being of the child. The questionnaire includes the Rutter's child behavioral pattern (Rutter et al., 2001).
• In both studies, all the guidelines of RCT are applied (Moher and Schulz, 2005). Blinding of the clinicians is gained, as the orthodontists or dentists treating the children are not aware of the rationale of the study. Blinding is applied on all measurement of the documents.

8. Quality assurance plan. Quality of the data collected is secured by preliminary training that has been done concerning the input data and the registration processes. The collected data is monitored on regular basis, on clinical records this is done by three months intervals. The quality assurance of the clinical data is done by the same person who has trained the dental personnel by on-site monitoring and auditing. Immediate feed-back is given to the registering personnel concerning the quality of the records.